Cellceutix Corporation (OTCBB CTIX): At Cellceutix, we have an exciting pipeline. We have the expertise of a large pharmaceutical company, but we're also focused, nimble and willing to supplement our own creative energies with ideas from the outside. We're focused on our lead candidate, Kevetrin, which we plan to develop for head and neck cancer. And we're focused on developing high quality data and patents to support Kevetrin. We're also open to new ideas from outside as well as inside. As a matter of fact, our pipeline already includes compounds licensed from the outside to supplement those invented by one of our co-founders, Dr. Krishna Menon. We're willing to partner with anyone who will help us meet our goals. When you put all this together, it means we at Cellceutix have a very exciting opportunity to create real value for our shareholders, as well as for our ultimate customers, the patients.
[ February 17, 2016, 07:45: Message edited by: Bob Frey ]
Posted by moogoo gaipan on :
Should be about due for more news...........
Tue, Aug 25, 2009 7:30 AM Cellceutix Announces Acquisition of New Compound With High Blood Pressure Lowering Properties - GlobeNewswire Tue, Aug 18, 2009 5:32 AM Cellceutix Corp executes manufacturing agreement for Kevetrin API - M2 Presswire Mon, Aug 17, 2009 8:00 AM Cellceutix Signs Agreement for Kevetrin(tm) API - GlobeNewswire Wed, Jul 22, 2009 11:22 AM Stock Watch: CTIX, IFSL, LLFH - M2 Presswire 7:30 AM Cellceutix's Cancer Drug Shows No Significant Indications of Toxicity - GlobeNewswire Tue, Jul 14, 2009 5:41 PM Cellceutix Announces Dr. Samuel Danishefsky Joins Its Scientific Advisory Board - GlobeNewswire Mon, Jul 13, 2009 12:13 PM Stock Profiler.US: Stock Watch: BELM, MCII, CTIX - M2 Presswire 7:00 AM Cellceutix Announces Kevetrin(tm) Animal Model Testing Success Against Multi-Drug Resistant Lung Cancer Cell Lines - GlobeNewswire Tue, Jun 30, 2009 1:19 PM Stock Profiler.US: Stock Watch: ALKN, PGOG, CTIX - M2 Presswire 7:31 AM Cellceutix Announces Dr. Emil Frei to be On Its Scientific Advisory Board Through June 30, 2010 - GlobeNewswire Fri, May 22, 2009 7:21 AM Cellceutix Corp applies for cancer compound patent - M2 Presswire
Posted by moogoo gaipan on :
Check out the big + moves on minimal buys, and there's no IR-PR push on either.
Filings are up to date.
This could get very interesting.
Posted by moogoo gaipan on :
Forbes.com profile of Dr. Krishna Menon, CSO:
Krishna Menon President, Chief Scientific Officer and Director Cellceutix Corporation Beverly , MA Sector: HEALTHCARE / Biotechnology Officer since December 2007 61 Years Old Krishna Menon RCM, PhD, VMD served as President of Cellceutix Pharma since inception in June 2007. Following the acquisition, he was appointed President and a director. Dr. Menon, simultaneously therewith, also serves as the Chief Operating Officer at Kard Scientific, Inc. Dr. Menon is also the inventor of Kevetrin, our lead compound. Since June 2005, Dr. Menon is also the Chief Regulatory Officer (a non- executive officer position) at Nanoviricides, Inc. Dr. Menon has more than 35 years in drug development for academia and industry. Originally trained as a veterinary surgeon, Menon began his career as Chief Government Veterinarian for a major Parish in Jamaica. He segued to a three-year stint as Director of Agriculture for the Cayman Islands, in the British Caribbean and, in 1982, moved to the Dana Farber Cancer Research Institute, where he worked under the direction of Nobel Laureate Dr. Tom Frye. Two years later, he earned his PhD in Pharmacology from Harvard University. Menon's PhD work focused on anti-folate therapy of various cancers. Menon was Research Scientist at Dana Farber from 1985 to 1990 and Senior Research Scientist, In Vivo Research (Cancer), at Bayer Pharmaceuticals (Miles Laboratories) from 1991 to 1993. After a year operating his own veterinary oncology and drug development consultancy practice, Menon was tapped Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly (1995-2001), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta which in 2006 had over 2.1 billion dollars ($2,100,000,000) in sales, and co-developed another seven compounds currently in late-stage clinical development. In 1999, Lilly honored Menon as "Employee of the Year." Lilly's is one of the few "Employee of the Year" awards not bestowed annually but, rather, on only special occasions. .
Posted by moogoo gaipan on :
Should see news on this stock soon.
Meds to fight drug-resistant cancer.
Posted by moogoo gaipan on :
CTIX's approach to drug-resistant cancer:
Excellent results in animal model experiments in drug-resistant cancers Kevetrin, our lead product candidate, is a small molecule compound proprietary to the Company. Its structure is distinct from other anti-cancer agents currently on the market. Kevetrin was discovered by the Company's founder, Dr. Krishna Menon, and has been studied extensively (in vitro and in vivo) demonstrating potent anti-cancer activity against various cancer cell lines. Kevetrin's recent success in a series of animal model experiments with drug-resistant cancer cell lines, has galvanized the Company to focus on Kevetrin's development potential in this area. Kevetrin's primary mechanism of action is as an AKT inhibitor but it also acts as an alkylating agent and LTB4 inhibitor with anti-angiogenic properties. Some highlights of the studies conducted to date include: * Small molecule drug that is structurally different from anti-cancer agents currently on the market * Primary mechanism of action is AKT inhibition * Potent in vitro cytotoxicity against a panel of human tumor cell lines * Demonstrated success in more than 5,000 small animal tests, achieving significant delays in tumor growth compared to controls in breast, prostate and colon cancer tumors. * In animal tests of a head and neck cancer cell line, delay in tumor growth was significantly increased by 14 days with Kevetrin alone (about the same as with radiation alone) but when Kevetrin was administered in conjunction with radiation, tumor growth delay increased by 36 days, more than two-fold compared to controls * In small animal tests, Kevetrin was well tolerated. We are now conducting additional studies to allow us to request permission from FDA to begin studies in humans.
CTIX is starting to get some trading activity now and the Bid-Ask has begun tightening up.
Perhaps some good news in on the way. Their website says they are looking to go to initial FDA trials soon. .
Posted by moogoo gaipan on :
CTIX NEWS: Cellceutix Meets With One of the World's Largest Pharmaceutical Companies At Partnering Meeting Sep. 23, 2009 (GlobeNewswire) --
BEVERLY, Mass., Sept. 23, 2009 (GLOBE NEWSWIRE) -- Cellceutix Corporation (OTCBB:CTIX), an emerging bio-pharmaceutical company in the business of developing small-molecule therapies in areas of unmet medical needs, announced today that its officers met with one of the world's largest pharmaceutical companies at the pharma's partnering meeting last week. Cellceutix was invited to introduce its anti-inflammatory drug pipeline in "face to face" meetings with the business development staff of this major pharmaceutical company, whose name was not disclosed. The pharmaceutical company is seeking the best advances in modern medicine to strengthen its R&D portfolio.
"We were taken by surprise to have received this prestigious invitation considering we have released very little information about these specific compounds. To have received this invite is testament to the quality of Cellceutix's compound pipeline and the supporting science," said Leo Ehrlich, chief financial officer of Cellceutix. "As we move the compounds along in development, we will continue to communicate with this pharmaceutical company as well as others. Currently we are expending an enormous effort on Kevetrin, our lead oncology compound, which has consistently shown success in animal models against drug resistant cancers. Of our compounds, this drug is furthest along in preclinical development and we hope to progress it rapidly through Phase 1 clinical studies."
About Cellceutix Corp.:
Headquartered in Beverly, Mass., Cellceutix is an emerging bio-pharmaceutical company in the business of developing small-molecule therapies in areas of unmet medical needs. It owns the rights to seven drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-133, which it is developing for psoriasis. For more information, visit: www.cellceutix.com.
This release contains forward-looking statements with respect to the results of operations and business of Cellceutix Corporation, which involve risks and uncertainties. The Company's actual future results could materially differ from those discussed. The Company intends that such statements about the Company's future expectations, including future revenues and earnings, and all other forward-looking statements, be subject to the "Safe Harbors" provision of the Private Securities Litigation Reform Act of 1995.
All forward-looking statements are also expressly qualified in their entirety by the cautionary statements included in Cellceutix's SEC filings, including its quarterly reports on Form 10-Q and its annual report on Form 10-K. Positive results in animal studies do not necessarily predict success in human trials.
CONTACT: The Mishra Group, Inc. Upendra Mishra (781) 466-9900, ext. 215 Umishra*MishraGroup.com
Cellceutix Corp. Leo Ehrlich (978) 633-3623 Leo*Cellceutix.com .
Posted by moogoo gaipan on :
Pharmaceutical Micro-Cap Company Demonstrates Significant Delay of Tumor Growth in Drug Resistant Breast Cancer
By: **************.com News
September 22, 2009 It is the scourge of our era, and that era’s women. More than 1.3 million women worldwide are diagnosed with breast cancer annually, and more than a third of these (465,000) will lose their battle with the deadly disease. About 41,000 of these deaths will be in the United States, according to the latest figures from the American Cancer Society.
The cry for a treatment, a cure - to be more optimistic, a preventive measure – is growing louder day by day, for these numbers are tragically high. Fortunately, the cry is being heard in several quarters of the medical community, provoking cheers of delight from patients, their doctors, and small cap investors.
On the last official, full day of summer came word from Cellceutix Corporation (OTCBB:CTIX), a Massachusetts-based researcher, that successful tests had been completed on animals involving the company’s pharmaceutical compound known as Kevetrin™. The tests were performed on a taxane-resistant, estrogen receptor-negative breast cancer human cell line, MDA-MB-435s, and compared favorably with other cancer fighters such as paclitaxel and cisplaten in delaying tumor growth.
A news release, issued after the closing bell on September 21, reported that tumor volume was reduced by 72%, tumor growth by 52%, results that were far superior to the other two substances. There was also no significant weight loss in the mice used in the experiments.
CTIX President, Dr. Krishna Menon, said the results were consistent with those of multi-drug resistant lung cancer cell lines the company came out with in July.
Cellceutix, based in the town of Beverly, MA, owns the rights to seven drug compounds, including Kevetrin which it is developing as a treatment for certain cancers, and KM-133, which it is developing for the treatment of psoriasis. On its website, CTIX likens its approach to drug research to that of New England weather; if you don’t like it, wait a minute. By which the company means, if things look dull on the research front, folks are urged to remember that developments change day to day, and that they never know what to expect.
The company’s exploits with Kevetrin provide a case in point. The product was initially applied to fighting head and neck cancers, a market CTIX considers underserviced, but has also since been applied to the battle against other cancers, as we have seen. The patent battle involving Kevetrin is one the higher-ups at the company consider well worth it, as, quote, “this complex and far-reaching patent is now filed with much broader claims than we imagined at the beginning of the patent process.” Simply put, Kevetrin has all the marking of a flagship product for Cellceutix.
The news of the successful tests were greeted with plenty of investor interest; although the price dipped a dime to about 70 cents the day after the press release, volume was at its yearly high, showing that investors are seeing value in this pharmaceutical micro-cap. While the stock is still in bargain territory, it’s appreciably dearer than the 15-cent mark at which the company found itself last November, giving bargain sleuths a stronger sense of urgency.
Tue, Oct 06, 2009 8:15 AM A New Audio Interview with Cellceutix Corporation's CEO, George Evans, is Now at SmallCapVoice.com - Business Wire 3:57 AM Opinions Requested on Proprietary Compound Successfully Tested: Review Initiated by Online Financial Magazine and Investor Social Network - M2 Presswire Mon, Oct 05, 2009 8:17 PM AXcess News: Breast Cancer Awareness Draws Investors Too - Marketwire 4:01 PM Cellceutix Compound Shows Significant Effect On Psoriasis - GlobeNewswire .
Posted by alan93 on :
Looks like you guys are posting this one into the ground.
Posted by moogoo gaipan on :
CTIX - starting to see a little volume amost every day now; non-toxic breast & other cancer drugs in the pipeline to trials........
CELLCEUTIX CORP - Nasdaq: CTIX Time & Sales most recent next page Rec. Time Action Price Volume 2:24:45 PM Trade 0.55 350 12:12:34 PM Trade 0.55 1700 10:19:40 AM Trade 0.55 1244 10:19:17 AM Ask 0.55 2500 10:10:21 AM Trade 0.58 1000 10:03:29 AM Trade 0.58 629 9:53:10 AM Bid 0.31 5000 9:53:10 AM Trade 0.45 200 9:53:08 AM Trade 0.45 800 9:30:35 AM Trade 0.58 1000 9:30:35 AM Trade 0.58 2000 9:04:18 AM Ask 0.58 2500 9:04:18 AM Bid 0.45 5000 9:04:02 AM Ask 0.6 2500
Cellceutix Confident as Cancer Compound Shows Activity in All Cancers Tested Cellceutix Updates Shareholders; Answers Questions About Clinical Trials for Novel Cancer Drug
Cellceutix Hits Major Milestone in Company History; Dosing Underway for New Cancer Drug at Leading Hospitals
Kevetrin is First-in-Class of Novel Chemistry to Reach Clinical Stage
BEVERLY, MA – November 8, 2012– Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to report that dosing of patients is now being conducted in clinical trials with Kevetrin(TM), the Company’s novel anti-cancer drug candidate, at Harvard University’s Dana Farber Cancer Center and Beth Israel Deaconess Medical Center.
This major milestone transitions Cellceutix into a clinical stage biotech company with a novel drug in some of the leading cancer hospitals in the world. Kevetrin has reached its initial clinical stage goal of Phase 1 human trials for solid tumors and the protocol is now being written for clinical trials in blood cancers at university-sponsored studies in Europe.
“These advancements for a small biotech company could not have been possible without the dedication and passion our whole team demonstrated working on Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Kevetrin has shown in laboratory studies to activate p53, ‘the Guardian Angel Gene,’ to reduce tumor volume and slow tumor progression in cancers which other drugs were ineffective in doing so. A completely new class in chemistry, we believe that our novel drug is something that the cancer industry has been in search of for decades. We have extremely high expectations for Kevetrin.”
About Kevetrin™
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function, which Kevetrin appears to be doing the majority of the time.
The clinical trial titled, “A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors,” is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.
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Cellceutix Signs Material Transfer Agreement for Research of Kevetrin in Lymphoma and Multiple Myeloma Cancers With Major Cancer Center Press Release: Cellceutix – 19 minutes ago
BEVERLY, MA--(Marketwired - Jun 26, 2013) - Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces today that the Company has signed a Material Transfer Agreement (MTA) with The University of Texas M.D. Anderson Cancer Center ("MD Anderson"). Per the MTA, Cellceutix will provide MD Anderson with Kevetrin, the Company's novel anti-cancer drug candidate, for laboratory research of Kevetrin as a potential new treatment for Lymphoma and Multiple Myeloma.
MD Anderson intends to utilize in vivo and in vitro methods to research specific pathways, gene expression, mechanism of action and apoptotic activity of Kevetrin in a range of concentrations and time points in both mutant and wild-type p53 Myeloma and Lymphoma cell lines. Research is also planned to evaluate Kevetrin against models of Multiple Myeloma cell lines that are resistant to bortezomib, lenalidomide and other FDA-approved chemotherapies. Additional studies will be conducted evaluating the anti-tumor activity of Kevetrin when used as a combination therapy with several FDA-approved drugs. MD Anderson will provide funding for these studies of Kevetrin defined by the MTA.
"This is another significant development in our advancement of Kevetrin. We are thrilled by the collaboration and MD Anderson's interest in researching Kevetrin as a potential new drug for Multiple Myeloma and Lymphoma," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "Currently moving through clinical trials for solid tumors at Harvard's Dana-Farber Cancer Center, Kevetrin being evaluated for blood cancers at MD Anderson puts our novel drug in the hands of innovative and experienced scientists at two of the most prestigious cancer research centers in the world, bar none. MD Anderson has defined a robust course of study that will provide invaluable insight to the anti-tumor activity of Kevetrin that will be used to plan for additional clinical trials as we continue to execute our strategy to aim Kevetrin at a broad spectrum of cancer lines."
About MD Anderson
Employing more than 19,000 people caring for more than 110,000 cancer patients in 2012, the mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public. From 2001 through 2012, MD Anderson has ranked No. 1 in cancer care in the "Best Hospitals" survey published in U.S. News & World Report, in addition to many other accolades.
About Myeloma
Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). It is also called Kahler disease, multiple myeloma, myelomatosis, and plasma cell myeloma. The National Cancer Institute estimates that there will be 22,350 new cases of myeloma diagnosed in 2013 in the United States and that there will be 10,710 deaths from the disease. Myeloma constitutes approximately one percent of all cancers in the United States.
About Kevetrin™
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.
Further information on the clinical trial, titled "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
Contact: Cellceutix Corp. Leo Ehrlich (978) 236-8717 Email Contact
Posted by BooDog on :
Cellceutix Completes Acquisition Of Polymedix Assets, Immediately Plans Brilacidin™ Phase 2b Clinical Trial For Acute Bacterial Skin And Skin Structure Infections (ABSSSI) and Phase 2 Clinical Trial For Oral Mucositis
Beverly, MA -- 09/16/13 -- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company, is pleased to provide shareholders an update regarding the Company’s recent acquisition of the assets of PolyMedix. In the acquisition announced September 9, 2013, Cellceutix acquired substantially all of the assets of PolyMedix, including multiple compounds, two of which were in clinical trials, equipment assets at the former PolyMedix headquarters, as well as the Intellectual Property relating to drugs in the pipeline.
The Company has decided to immediately advance the Brilacidin compound portfolio asset. The Company now has in its possession all of the research data from the PolyMedix pipeline, including the Phase 2a clinical data from the antibiotic Brilacidin. The plan is to immediately advance Brilacidin into a Phase 2b clinical trial for acute bacterial skin and skin structure infections, or ABSSSI. Under the initiatives of the GAIN Act (Generating Antibiotic Incentives Now) passed in 2012, the Company intends to pursue an expedited regulatory review process, which can include Fast Track designation, for Brilacidin.
Brilacidin has also demonstrated potent activity as a potential new therapeutic for oral mucositis, an often-serious complication of chemotherapy and radiation therapy for cancer. Prior to PolyMedix’s bankruptcy, the company had communicated with the U.S. Food and Drug Administration (“FDA”) and was near completion of an Investigational New Drug application to move the drug into a Phase 2 trial for oral mucositis. Cellceutix has prioritized to complete this process and submit the application to the FDA. It is the Company’s understanding that oral mucositis is a qualifying condition under the Orphan Drug Act, a designation that Cellceutix intends to pursue.
Additionally, Cellceutix is now studying scientific data that show Brilacidin as a potential treatment for other indications. An examination of data and collaboration with researchers has shown a strong potential for Brilacidin for inflammatory bowel diseases, such as Crohn’s disease, as well as wound infections. After studies are completed at Cellceutix, the Company will update shareholders on its plan going forward, particularly on Crohn’s disease.
The Company has also started reviewing other newly acquired compounds and, in particular, sees strong possibilities in PMX-10098 for fungal infections. The Cellceutix team intends to immediately begin further research.
Chief Executive Officer of Cellceutix, Leo Ehrlich commented, “The energy at Cellceutix is very high as we believe we hit a home run with the PolyMedix acquisition, especially as it pertains to Brilacidin. The reality of owning these assets is now beginning to set in. With Brilacidin, there is very little work to be done to advance this compound into two different Phase 2 clinical trials. Brilacidin is the ‘low hanging fruit’ in this acquisition with tremendous upside potential. We believe that the clinical development of the Brilacidin franchise will firmly stamp our name in the lucrative and rapidly growing antibiotic industry. The only feeling that parallels my pride in our accomplishments to date is my excitement for the future.”
Posted by BooDog on :
Cellceutix Completes Final Study to File IND Application for New Psoriasis Drug Prurisol(TM) MarketwiredPress Release: Cellceutix – 47 minutes ago..
CTIX 1.77
BEVERLY, MA--(Marketwired - Oct 2, 2013) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, today announces that the bridging study on Prurisol, the Company's anti-psoriasis drug candidate, has been completed by an outside vendor and that Cellceutix has received the report. The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug ("IND") application with the FDA under a 505(b)(2) designation. This completes the lab studies needed for filing an IND for Prurisol.
Cellceutix is reviewing clinical sites in the United States and internationally to initiate a Phase 2/3 trial as Dr. Reddy's Laboratories Ltd. finalizes the Chemistry, Manufacturing, and Controls section ("CMC") of the IND. The CMC is expected by the end of the month and the IND filing shortly thereafter. Dr. Reddy's has already completed the manufacturing and stability studies of Prurisol for a multi-center clinical trial.
"I wish to thank Dr. Reddy's Laboratories for their assistance in this study. The results from the final study for the FDA submission were exactly as expected. We are very eager to move Prurisol into a large-scale human trial, where we are optimistic that the drug will validate earlier research and prove itself as a new, potent therapeutic for psoriasis," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Meanwhile, we are moving quickly with the regulatory work with our new antibiotic, Brilacidin™, to begin a Phase 2b clinical trial for ABSSSI and phase 2 trial for oral mucositis. In recent weeks, we have added to our clinical support staff in preparation for all of the trials in addition to the ongoing Phase 1 trial of our anti-cancer drug Kevetrin™. We have been advised that the Safety Review Committee is meeting early next week to determine the dosing levels of Kevetrin for the sixth cohort in the trial at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. We anticipate that the dosing will be above 100 mg/m2, a level that we have considered an important dose since the trial began. This is an exciting time as there are many, many positive developments happening concurrently as we align to conduct multiple clinical trials with our extremely promising compounds."
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company focused on developing and commercializing its pipeline of compounds for novel therapies in areas of serious unmet medical need, including cancer, psoriasis and antibiotic applications. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission. . . Contact:. . Cellceutix Corp. Leo Ehrlich (978) 236-8717 Email Contact
Posted by BooDog on :
This is pretty good news for Cellceutix. Getting some nice backing going forward.
Cellceutix Antibiotic Brilacidin Chosen by Elsevier as “Top Project to Watch” in Infectious Disease
Cellceutix Drug Brilacidin™ May Be The Key Antibiotic on the Horizon for Serious Skin Infections; Plans to Start Phase 2b Study in January 2014
Antimicrobial resistance is one of our most serious health threats states Centers for Disease Control. Declares Urgency for New Antibiotic Drugs.
Beverly, MA -- 10/14/13 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that the Company is completing the required documentation to begin a Phase 2b clinical trial of Brilacidin as a new drug candidate for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI.
Based upon what Cellceutix can only describe as exceptional results in a completed Phase 2a trial and building upon guidance from prior meetings regarding Brilacidin with the Division of Anti-Infective Products of the U.S. Food and Drug Administration, Cellceutix is planning to advance the clinical development of Brilacidin in a Phase 2b dose-optimization clinical trial. The trial will include a single-dose regimen as well as a three-day dosing regimen using Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Cellceutix believes that, based upon consultation, the trial will begin in January 2014.
In September, the Centers for Disease Control and Prevention (“CDC”) released a report, entitled, “Antibiotic Resistance Threats in the United States, 2013.” Specifically, the report stated “Antimicrobial resistance is one of our most serious health threats” as part of an analysis of the “potentially catastrophic consequences of inaction” in a growing epidemic where resistance to current antibiotics is leaving few options that are generally less effective and more expensive. Cellceutix is diligently working to commence the Brilacidin Phase 2b trial as well as exploring accelerated approval programs available with the FDA to meeting this area of great unmet medical need.
“More than two million Americans acquire serious bacterial infections annually. The CDC has made it clear as to how critical it is to develop new therapies to address this fact, which has recently been highlighted by news of National Football League and NFL Players Association acknowledging a problem with MRSA infections.” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Brilacidin is the first of an entirely new class of antibiotics, known as defensin-mimetics. It can rapidly kill the bacteria that cause ABBBSI, including resistant strains of Staph aureus, such as MRSA. Also, unlike most antibiotics, Brilacidin has minimal potential to promote the further development of resistant strains. This is because of its unique mechanism of action, as well as its ability to be given as a short course regimen, perhaps as a single dose. Both single and 3-day dosing regimens will be explored in the upcoming phase 2b study. Single-dose therapy removes patient non-adherence as a driver of antimicrobial resistance, and it allows for reduced health care costs, as patients do not need to return to the clinic or hospital for additional doses.”
Dr. Menon added, “Brilacidin could be the key antibiotic on the horizon for serious skin infections. Based on sales of antibiotic compounds and recent billion-dollar acquisitions that reflect the value of new antibiotics, we are very excited and believe that an FDA approved Brilacidin would capture a significant share of the ABSSSI market, due to its unique attributes, including short-course therapy. With ABSSSI as the lead indication, followed by other possible uses for infected wounds, bone, joint and blood stream infections, Brilacidin could fill a large void in the dwindling global portfolio of effective antibiotics. Our strategy includes capitalizing on the Generating Antibiotics Incentives Now (GAIN) Act, which, combined with other government efforts, is positively changing the regulatory climate in the developmental of drugs like Brilacidin.”
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company focused on developing and commercializing its pipeline of compounds for novel therapies in areas of serious unmet medical need, including cancer, psoriasis and antibiotic applications. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
Posted by BooDog on :
The Centers for Disease Control and Prevention 2013 Threat Report:
News for 'CTIX' - (Cellceutix to Pursue Significant Conjuctivitis and Kerititis Ocular Markets With Novel Antibiotic Brilacidin)
BEVERLY, MA, Nov 04, 2013 (Marketwired via COMTEX) -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to inform shareholders that the Company is conducting experiments on Brilacidin(TM), its lead antibiotic compound, for ophthalmic infections, including keratitis and conjunctivitis. Cellceutix estimates the market potential for these indications well in excess of $1 billion and has its antibiotic team expanding upon the significant amount of preclinical research that has been conducted on Brilacidin for these conditions.
Prior to the Cellceutix acquisition of PolyMedix in September, lab studies conducted at the Charles T. Campbell Ophthalmic Microbiology Laboratory at the University of Pittsburgh demonstrated the safety, tolerability and broad activity of Brilacidin against clinically important Gram-positive and Gram-negative pathogens, including drug-sensitive and drug-resistant clinical isolate strains of ocular infections.
Pharmacokinetic studies were conducted at Iris Pharma, a Contract Research Organization based in France, showing that Brilacidin has a high residence time on the surface of the eye with negligible systemic exposure. This indicates that effective therapeutic concentrations of Brilacidin can be maintained in the eye with infrequent treatments.
As a defensin-mimetic, Brilacidin is a completely novel class of antibiotics and a platform for a broad spectrum of indications in an area of urgent need for new drugs. Topical ophthalmic anti-infective drugs that are used today for keratitis and conjunctivitis have serious limitations due to bacterial resistance and serious side effects. For example, although exclusive of topical uses of fluoroquinolones for eye and ear infections, the U.S. Food and Drug Administration in August required that drug labels and Medication Guides for all systemic fluoroquinolone antibacterial drugs be updated to describe the potential serious side effect of peripheral neuropathy.
"The Brilacidin ocular data is highly exciting. Our new research program focusing on ocular drugs is the next step in expanded uses of Brilacidin that we believe will develop into a blockbuster antibiotic drug franchise," said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "We have a litany of clinical and preclinical data on Brilacidin. Our research staff is currently growing epithelial cells for testing so that we can formulate Brilacidin as a topical solution with efficient penetration of the epithelium to maximize clinical results."
"We are going to continue aggressively moving forward with Brilacidin as the current biotechnology environment is desperate for new therapeutics," added Leo Ehrlich, Chief Executive Officer at Cellceutix. "Reuters reported only yesterday that Swiss drugmaker Roche is poised to get back into antibiotics because of a novel drug that they want to develop to tackle drug-resistant bacteria. Simply, a novel drug has phenomenal sales potential. Johnson & Johnson's Levaquin was generating $1.3 billion in sales before it came off patent. Cubist's Daptomycin for ABSSSI only comprised 8 percent of total doses, yet controlled approximately 82 percent of total sales in that market. The majority of approved antibiotics today are legacy drugs or variations of them for which resistance is constantly evolving. Our plan is to establish Brilacidin as the next generation antibiotic. It has opened a door to a multi-billion-dollar pathway and we are not just looking at it, we are part way through it and moving as quickly as possible to establish a leadership position."
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is being readied for a Phase 2/3 clinical trial at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is set to begin a Phase 2b trial in the first half of 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. Cellceutix has formed research collaborations with world renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
Email Contact
SOURCE: Cellceutix
(C) 2013 Marketwire L.P. All rights reserved.
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SUBJECT CODE: Pharmaceuticals and Biotech:Biotech
Pharmaceuticals and Biotech:Trials
Pharmaceuticals and Biotech:Equipment and Supplies
Pharmaceuticals and Biotech:Drugs
Posted by BooDog on :
Cellceutix to Initiate Psoriasis Clinical Trial
Company Conducting Three Clinical Trials for Three Separate Areas of Unmet Medical Need
BEVERLY, MA--(Marketwired - Mar 21, 2014)- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the U.S. Food and Drug Administration’s (“FDA”) 30-day waiting period pertaining to the Company’s Investigational New Drug Application (“IND”) for Prurisol™ has now passed. Cellceutix is moving towards the commencement of clinical trials of Prurisol™ as a new drug candidate for the treatment of psoriasis.
“This is another significant moment for our Company as we bring our third compound into clinical trials,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “A steady stream of developments has led to a great start to 2014 for our Company. We initiated a multi-center Phase 2b trial of our novel antibiotic Brilacidin. The Phase 1 trial of our novel anti-cancer compound Kevetrin™ is in the seventh cohort and now Prurisol™ is set to enter human trials, positioning us with three clinical drug candidates targeting three different areas of unmet medical need.”
“I am also excited about the laboratory research that is being conducted on Brilacidin for a wide range of indications,” added Mr. Ehrlich. “We are nearing completion of IND-enabling studies of Brilacidin-OM for oral mucositis. Other pre-clinical studies of Brilacidin are ongoing for otitis and ophthalmic infections. Separately, in our recent acquisition of assets we acquired a library of compounds that have shown promise for Gram-negative bacterial infections. These compounds have been sent to a university laboratory in Texas for further testing. We are actively developing other acquired compounds for anti-fungal treatments. In short, while we are very pleased with the clinical development to date, we feel that there are many other areas of tremendous opportunity for our pipeline and intend to relentlessly research them to define future clinical trials.”
Cellceutix is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate development pathway. The initial clinical research will be a brief Bioequivalence crossover study expected to last approximately 45 days with the primary endpoint of demonstration that Prurisol converts to abacavir in humans, as it has been shown to do in animal models. Upon successful completion of the crossover trial, the Company will initiate a larger Phase 2/3 clinical trial under a 505(b)(2) designation, which would permit Prurisol to move to advanced trials because the active moiety of Prurisol is that of a drug already approved by the FDA.
Cellceutix management previously submitted to the FDA an application for an Orphan Drug designation for Brilacidin-OM for the prevention of oral mucositis in head and neck cancer patients. After reviewing the extensive data supplied with the application, the FDA advised the Company that the data would indicate that Brilacidin–OM could treat a patient population that is actually too large for an Orphan Drug designation. Although the Company is glad that the market is potentially much larger than initially thought, meaning that Brilacidin-OM would be beneficial to so many more people suffering from this terrible disease, Cellceutix management is evaluating all scenarios. The Company may narrow the focus of the application and continue the dialogue with the FDA going forward or pursue the larger market. The Company believes either option presents the potential to capture significant market share with the introduction of a new therapy for oral mucositis.
About Cellceutix: Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is being readied for clinical trials at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Posted by BooDog on :
Did The Medicines Company Trump Cellceutix And Others In A $1B-Plus Skin Infection Market?
Cellceutix to Present at Rodman & Renshaw's 16th Annual Global Investment Conference 3 days 20 hours 6 minutes ago - DJNF Cellceutix to Present at Rodman & Renshaw's 16th Annual Global Investment Conference BEVERLY, MA--(Marketwired - Sep 5, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announced today that Leo Ehrlich, CEO will be presenting Cellceutix at the 16(th) Annual Rodman & Renshaw Global Investment Conference, on Tuesday, September 9 at 3:20 PM EDT.
The conference is being held at the Palace Hotel in New York City from September 8 - September 10. The webcast can be listened to live at http://wsw.com/webcast/rrshq24/ctix and thereafter will be archived for 90 days on the Rodman & Renshaw website and archived as well on the Cellceutix website.
"We are very pleased to once again be presenting at the Rodman and Renshaw annual investment conference," said Leo Ehrlich, Chief Executive Officer at Cellceutix. "In a live webcast for institutional and other investors, we will be providing a comprehensive update on Kevetrin and Prurisol clinical trials and our observations of the recently completed Brilacidin ABSSSI Phase 2b trial. In addition we will be announcing significant corporate developments pertaining to our programs in oral mucositis, and antibacterial and antifungal infections."
The effectiveness of the Company’s internal control over financial reporting as of June 30, 2014 has been audited by Baker Tilly Virchow Krause, LLP, an independent registered public accounting firm, as stated in their report, which appears herein.
Cellceutix to President Obama: We Have The Tools And Will Rise Up To The Challenge To Prevent Antibiotic Resistant Bacteria Becoming A Serious Threat to Public Health
Posted by BooDog on :
U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, - See more at: http://cellceutix.com/cellceutix-antibiotic-brilacidin-receives-qidp-designation -from-fda/#sthash.60YVYS9o.dpuf Posted by BooDog on :
4.52 hod and still looking good.
4.52 1.17 34.93% 3,812,503 214.7K
Posted by BooDog on :
CTIX conference coming up on Monday.
I've still been flipping some of this along the way.
Added back in 3.82 Dec 17th
Posted by BooDog on :
Cellceutix at ASCO 2015
A phase 1, dose-escalation, safety, pharmacokinetic, pharmacodynamic study of thioureidobutyronitrile, a novel p53 targeted therapy, in patients with advanced solid tumors.
Sub-category: Cytotoxic and Other Novel Agents
Category: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Author s Geoffrey Shapiro, James Walter Mier, John Frederick Hilton, Leena Gandhi, Nicole G. Chau, Andrea J. Bullock, Jeffrey G Supko, Sigitas Jonas Verselis, Kayla Murgo, Cameron Sze, Susan Gotthardt, Andrew Wolanski, W. James Alexander, Ashok Kumar, Sylvia Adell Holden, Karima Chafai-Fadela, Siya Ram, Krishna E. Menon; Dana-Farber Cancer Institute, Boston, MA; Department of Medicine, Dana-Farber/Harvard Cancer Center, Beth Israel Deaconess Medical Center, Boston, MA; Beth Israel Deaconess Medical Center, Boston, MA; Massachusetts General Hospital Cancer Center, Boston, MA; Cellceutix Corporation, Beverly, MA; Cellceutix Corp, Beverly, MA; Cellceutix, Beverly, MA
Abstract Disclosures
Abstract:
Background: Thioureidobutyronitrile, Kevetrin, induced apoptosis in wild type p53, mutant p53 and p53 null cell lines. In A549 lung carcinoma cells, wild type p53 was stabilized by Kevetrin. Kevetrin induced nongenotoxic activation of the p53 signaling pathway. Kevetrin also induced p21 and PUMA, known transcriptional targets of p53. Kevetrin caused accumulation of monoubiquitinated p53 and induced transcriptional independent apoptosis. In p53 mutant breast carcinoma cells (MDA-MB-231), Kevetrin induced degradation of hyperstable oncogenic mutant p53 and induced apoptotic cell death. Apoptotic cell death was also induced in K-562, a p53 null CML cell line. Consistent with in vitro data, Kevetrin showed potent antitumor activity in wild type p53 (A549), mutant p53 (MDA-MB-231), and p53 null (K-562) human tumor xenograft models. Kevetrin has the unique ability to target both wild type and mutant p53 tumors controlling tumor growth in various preclinical tumor models (ASCO 2013). Based on the pre-clinical data, a Phase I study was initiated at Dana-Farber/Harvard Cancer Center in 2012. Methods: Adults with refractory locally advanced or metastatic solid tumors, acceptable liver, kidney function, and hematologic status were eligible. Objectives include determination of DLT, MTD, pharmacokinetics, pharmacodynamics, and evaluating preliminary evidence of antitumor activity. Kevetrin is given as an intravenous infusion once weekly for 3 weeks in 28-day cycles. The starting dose was 10 mg/m2. In a 3+3 design, groups of 3-6 patients are evaluated for toxicity at each dose level. Dose escalation is based upon the number and intensity of adverse events in cycle 1. Kevetrin PK is characterized for the first and last doses given in cycle 1. Kevetrin induced p21 in lymphocytes preclinically; therefore p21 expression in peripheral blood mononuclear cells is measured as a PD biomarker. Antitumor activity by RECIST 1.1 criteria and serum tumor markers is assessed. The p53 status of tumors of selected patients will be determined. The first nine cohorts were completed in December 2014. Enrollment in the tenth cohort at 450 mg/m2 began January 2015. Clinical trial information: NCT01664000
CTIX May 21st “Understanding QIDP and Other 21st Century Incentives for Developing and Marketing Anti-Infective Medicines,” on May 21, 2015 at the New York Palace Hotel.
This investor event will be focused on the positive impact of the GAIN Act and the QIDP designation on investments in companies with anti-infective programs. The event is designed to help investors understand how leveraging various regulatory and commercial incentives translate to increased shareholder value. Speakers will include regulatory attorneys, legislators, industry executives and medical professionals. Investors interested in attending should contact Tirth Patel of Tiberend Strategic Advisors, Inc.: tpatel@tiberend.com.
Recounts Brilacidin information previously released.
Gram negative drug has the potential to be another big winner,CC-1807
New information regarding the gram negative drug: CC-1807 being optimized for urinary tract infections, bacteremia and lung infections {pneumonia}
Optimized for expanded Gram neg coverage to include Pseudomonas and Acineobacter
From power point:
Gram-negative activity evident in several structural series of small nonpeptidic mimetics of host defense proteins
2 series show low cytotoxicity, favorable PK properties and robust efficacyin vitro and in vivo against Enterobacteriaceae organisms
CC-1807 is potently active against clinical isolates of E. coli, K. pneumoniae and E. cloacae, including MDR CRE strains
Additional preclinical efficacy studies with CC-1807 are in progress
Dose optimization in lung infection models UTI and bacteremia
Chemical optimization of CC-1807 and additional analogs is continuing Expand coverage to Pseudomonas and Acinetobacter spp
===================================================
Posted by BooDog on :
The Phase 1 study with Kevetrin, CTIX-0000, is in progress at DanaFarber/Harvard Cancer Center in subjects with various solid carcinomas; the majority of which are gynecological cancers. 10 cohorts of subjects have been completed; the 11th cohort is ongoing. Only 1 DLT has been observed to date, but the MTD has not yet been reached. The current dose is 750 mg/m2, 75-fold greater than the starting dose. Kevetrin was shown to activate wild type p53 and degrade mutant p53. Since Kevetrin activates both transcriptional-dependent and transcriptional-independent pathways to promote apoptosis through wild type p53 activation and degrades oncogenic mutant p53, Kevetrin can function as a major inducer of apoptosis in many types of tumors independent of p53 mutation status. In this Phase 1 study, the biomarker, p21 expression levels in peripheral blood, were increased in 68% of subjects and 48% had an increase in p21 expression at a level of ≥10%. These results suggest that Kevetrin activates p53 by inducing p21 gene expression
Should be seeing the official launch of PIII sometime soon.
Company Reports Successful End-of-Phase 2 Meeting With FDA Cellceutix Corporation (CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has agreed to advancing brilacidin into phase 3 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). During a recently held End-of-Phase 2 Meeting, Cellceutix and the FDA discussed safety and efficacy data that support advancement into phase 3, as well as the basic elements of a phase 3 program. The planned phase 3 program would include two phase 3 ABSSSI studies, as required by FDA Guidance. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. - See more at: http://cellceutix.com/brilacidin/#sthash.rjnpNBBb.dpuf Posted by BooDog on :
The Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC)
Material Transfer Agreement Being Extended for Additional Research of Brilacidin to Prevent Infection in Implants
BEVERLY, MA–(Marketwired – Sept 16, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed pharmacokinetic/pharmacodynamic (PK/PD) model entitled “Population Pharmacokinetics (PPK)” of Brilacidin (BRI) in Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) will be presented as a “poster walk” at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy and 28th International Congress of Chemotherapy from 12:00 to 2:00 pm PDT on September 18 in San Diego, CA. The oral presentation will be given by the lead author of the poster, Dr. Scott Van Wart, of the Institute for Clinical Pharmacodynamics (ICPD). The poster will be available on the Cellceutix website beginning 12:00 pm PDT Friday, September 18, 2015.
Using data from three Phase 1 and two Phase 2 studies in acute bacterial skin and skin-structure infection (ABSSSI) patients, a population pharmacokinetic (PPK) model for BRI was developed to describe the time-course of BRI in plasma and to identify significant predictors of BRI PK. “We are pleased that this important information has been accepted for an oral poster presentation”, said Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. “This way, the audience has an opportunity to participate in an interactive question and answer discussion. More importantly, the audience will learn about state-of-the art modeling techniques that have informed the selection of Brilacidin doses in past Phase 2 studies and future Phase 3 studies.”
Dr. Jorgensen added, “There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need. The laboratory and clinical data presented at previous academic meetings, along with the newer PK/PD data to be presented at ICAAC, support the continued development of this promising class of compounds. We look forward to sharing these data at the ICAAC meeting.”
Separately, Cellceutix is pleased to provide and update on the Material Transfer Agreement (MTA) disclosed in November 2014 with a division of one of the largest U.S. pharmaceutical companies (the “Pharma”) for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. Cellceutix has been advised that initial testing is encouraging. The Pharma has requested an extension to the MTA with an additional order to conduct further analysis of Brilacidin for this prophylactic application. The MTA does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval.
“We feel the MTA extension and add-on order for additional research by such an esteemed organization is further validation of the potential of Brilacidin. These types of collaborations are important in expanding our defensin-mimetic drug discovery program in new verticals and we look forward to results from their testing in the future,” concluded Dr. Jorgensen.
Cellceutix Completes Clinical Trial of Kevetrin for Advanced Solid TumorsMarketwired(Tue, Feb 16)
BEVERLY, MA--(Marketwired - February 16, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce the successful completion of its Phase 1 trial of Kevetrin in patients with advanced solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.
The open-label, dose escalation study met Cellceutix's objectives by demonstrating the safety and tolerability of Kevetrin, while providing key information on the pharmacokinetics of Kevetrin. These data are being utilized in designing a Phase 2 study, which will evaluate Kevetrin as a component of combination therapy in the treatment of ovarian cancer. As disclosed on February 10, 2016, the U.S. Food and Drug Administration (FDA) informed Cellceutix that increasing the frequency of Kevetrin dosing from once weekly to three times weekly would be acceptable based upon the data from the Phase 1 study. We look forward to these future trials and are hopeful that Kevetrin will develop into one of the great cancer treatment drugs.
Cellceutix is developing Kevetrin under an Orphan Drug designation for ovarian cancer from the FDA.
Cellceutix would like to thank all the staff at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center for their tireless work and valuable insight throughout the clinical trial, especially the trial's Principal Investigator, Dr. Geoffrey Shapiro. The trial was a success and we appreciate the opportunities recently afforded to us to further expand enrollment for the purpose of excellent research on Kevetrin for better patient care.
Cellceutix is now informing clinicaltrials.gov that the trial is no longer active and expects the website to be updated soon to reflect the trial as completed.
About Cellceutix: Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its application for a Phase 2 study. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact:
INVESTOR AND MEDIA CONTACT: Cellceutix Corporation Leo Ehrlich
I don't condone half the crap SA puts out but this was nicely done.
Posted by BooDog on :
Half bio's are under the radar. The recent bio sector take down didn't help. ATNM CBAY CRBP are little ones that have nice long term potential. SYN MSTX CTIX have nice 2nd qtr catalysts that may bring some nice volatility back in. My new one is OMBP, you want under the radar, that one is buried. You want high volatility watch GNCA today, expecting that to be all over the place. Tried telling some to at least take some off but you can only tell the prawns. Most just think I'm bashing. $40 price target, yeah, P3 doesn't even start to come into the picture till next year. They leave that part out.
Okay, nuff rambling.
Posted by BooDog on :
Cellceutix Begins Phase 2b Clinical Trial of Oral Prurisol in Moderate-to-Severe Chronic Plaque Psoriasis BEVERLY, Mass., Oct. 31, 2016 (GLOBE NEWSWIRE) — Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that it has begun the screening of patients in its Phase 2b clinical trial of oral Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis.
This clinical trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment groups include oral Prurisol 300mg per day, oral Prurisol 400mg per day, and placebo (3:1:3 randomization, respectively). Duration of treatment is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment. The study is being conducted at approximately 30 sites throughout the United States.
This Phase 2b study increases the total daily dosing of Prurisol above 200mg, the maximum level used in our previously successful Phase 2 trial, which showed the drug candidate to be a promising treatment for psoriasis. Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs. In addition, multiple secondary endpoints will be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.
“We look forward to efficient execution of this important trial for our psoriasis program. Having partnered with one of the premier CROs in the Dermatology therapy area for this study, I am confident that we will be able to assess interim and final study results in a timely fashion,” said Jane Harness, Cellceutix VP, Clinical Sciences and Portfolio Management.
“The start of this study is a key milestone for our psoriasis program, bringing us closer to the Phase 3 registration program, and its results will further build upon the positive Phase 2 data reported earlier this year,” said Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer. “A new oral drug that delivers substantial efficacy, expanding choices for treatment, should command considerable market value and add value for our shareholders.”
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “This study is yet another example of the momentum emerging across our clinical portfolio of first-in-class drug candidates. Cellceutix continues to deliver diverse milestones. As to the Dermatology therapy area, multiple recent acquisitions by Big Pharma of companies with innovative therapies convince us that the Company’s strategic positioning is significantly strengthened as we make progress in this area.”
Cellceutix anticipates conducting an interim analysis of 6-week data from this Phase 2b trial in chronic plaque psoriasis with readout available in 2Q2017 and full study top-line results in 3Q2017.
Alerts:
Sign-up for Cellceutix email alerts is available at
Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA’s 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis. Cellceutix has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and efficacious in the highest dosing arm across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early (by week two) dose-dependent response that improved as treatment duration increased was observed. Cellceutix has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens.
About Psoriasis
Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities. Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
About 505(b)(2) Development Approach
Under the FDA’s 505(b)(2) development approach, a drug candidate’s road to market approval can be significantly shortened and conducted at a much reduced cost. Long-term safety data from a reference drug may be relied upon for approval, and potentially only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required to establish efficacy. For more information about the FDA’s 505(b)(2) development program, please visit: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly-traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix has now launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its plans for a Phase 2 study. In the laboratory, Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of oral mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Posted by BooDog on :
NO SPLIT. Cellceutix Announces Company Name Change to Innovation Pharmaceuticals Inc.
Corporate
BEVERLY, Mass., June 7, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), an emerging biopharmaceutical company, is pleased to announce to shareholders, and the public at large, that it is changing its name to Innovation Pharmaceuticals Inc. (IPI) and has received a new Committee on Uniform Securities Identification Procedures (CUSIP) number of 45782D 100.
Innovation Pharmaceuticals more accurately describes the innovative nature of our first-in-class pipeline of mid-stage drug candidates. These changes will have no impact on the marketability of the Company’s securities, or the ability to trade the common stock through brokerage firms. Stockholders of the Company are not required to exchange their stock certificates in connection with the name change.
The Company’s common stock will continue to trade under stock symbol “CTIX” on OTCQB until market close on June 8, 2017. Trading on the OTCQB under the new Innovation Pharmaceuticals name and ticker symbol “IPIX” will begin at market open on June 9, 2017.
The name change will be discussed at the upcoming live shareholder and investor conference call, to be held on Thursday, June 8, 2017, at 11am EDT. Senior Company management will be responding to recently posed questions submitted by email. Live call-in questions will also be addressed.
Below are call-in details for the conference call:
Title: Innovation Pharmaceuticals Shareholder and Investor Conference Call
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
Effective June 5, 2017, the registrant changed its corporate name from Cellceutix Corporation to Innovation Pharmaceuticals Inc. (the “Company”). In accordance with Section 92A.180 of the Nevada Revised Statutes, stockholder approval of the name change was not required.
In connection with Rule 6490 of the Financial Industry Regulatory Authority (“FINRA”) and Rule 10b-17 of the Securities Exchange Act of 1934, as amended, the Company submitted an issuer company-related action notification form to FINRA notifying FINRA of the name change and FINRA has confirmed that it will process the name change, effective at the open of business on June 9, 2017. In connection with the name change, the CUSIP number for the Company’s Class A common stock will change to 45782D 100. The Company’s Class A common stock will continue to be quoted on the OTCQB market but will trade under a new ticker symbol, “IPIX”.
A copy of the Company’s Articles of Incorporation, as amended, is filed herewith as Exhibit 3.1.
Item 7.01 Regulation FD Disclosure.
On June 7, 2017, the Company issued a press release announcing the name change. The full text of the press release is furnished with this Form 8-K as Exhibit 99.1 and incorporated by reference herein.
The information in this Current Report on Form 8-K under Item 7.01, including the accompanying press release, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by reference to such filing.
AMENDED AND RESTATED ARTICLES OF INCORPORATION OF INNOVATION PHARMACEUTICALS INC.
ARTICLE I
The name of the corporation (hereinafter referred to as the “Corporation”) is: “Innovation Pharmaceuticals Inc.”
ARTICLE II
The address of the Corporation’s registered office in the State of Nevada is United Corporate Services, Inc., in the City of Carson City, County of Carson. The name of the Corporation’s registered agent at such address is 202 South Minnesota Street, Carson City, Nevada 89703.
ARTICLE III
(a) Authorized Capital Stock.
(i) The total number of shares of stock that the Corporation shall have authority to issue is 410,000,000, consisting of
(ii) 300,000,000 shares of Class A Common Stock, par value $0.0001 per share (“Common Stock”) and
(iii) 100,000,000 shares of Class B Common Stock, par value $0.0001 per share (“Common Stock”)
(iv) 10,000,000 shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”).
The holders of shares of the Class A Common Stock shall not have the right to convert their shares of Class A Common Stock into any other securities.
The holders of shares of the Class B Common Stock at their election shall have the right, at any time or from time to time, to convert any or all of their shares of Class B Common Stock into shares of Class A Common Stock, on a one to one basis, by delivery to the Corporation of the certificates representing such shares of Class B Common Stock duly endorsed for such conversion. Any shares of the Class B Common Stock that are transferred will automatically convert into shares of the Class A Common Stock, on a one to one basis, effective as of the date on which certificates representing such shares are presented for transfer on the books of the Corporation.
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VOTING RIGHTS
Subject to the limitations provided by law and subject to any voting rights applicable to shares of the Preferred Stock, the Class A Common Stock and the Class B Common Stock shall have the sole right and power to vote on all matters on which a vote of shareholders is to be taken. In all matters, with respect to actions both by vote and by consent, each holder of shares of the Class A Common Stock shall be entitled to cast one vote in person or by proxy for each share of Class A Common Stock standing in such holder’s name on the transfer books of the Corporation; and each holder of shares of the Class B Common Stock shall be entitled to cast ten votes in person or by proxy for each share of Class B Common Stock standing in such holder’s name on the transfer books of the Corporation. Except as otherwise provided above and subject to the limitations provided by law and subject to any voting rights applicable to shares of the Preferred Stock, the holders of shares of the Class A Common Stock and Class B Common Stock shall vote together as a single class, together with the holders of any shares of the Preferred Stock which are entitled to vote, and not as a separate class.
(b) Preferred Stock. Preferred Stock may be issued from time to time in one or more series. The Board of Directors is hereby authorized to provide for the issuance of shares of Preferred Stock in series and, by filing a certificate pursuant to the Nevada Revised Statutes (“N.R.S.”) (hereinafter, along with any similar designation relating to any other class of stock that may hereafter be authorized, referred to as a “Preferred Stock Designation”), to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. The authority of the Board of Directors with respect to each series shall include, but not be limited to, determination of the following:
(i) The designation of the series, which may be by distinguishing number, letter or title;
(ii) The number of shares of the series, which number the Board of Directors may thereafter (except where otherwise provided in the Preferred Stock Designation) increase or decrease (but not below the number of shares thereof then outstanding);
(iii) The amounts payable on, and the preferences, if any, of shares of the series in respect of dividends, and whether such dividends, if any, shall be cumulative or noncumulative;
(iv) Dates on which dividends, if any, shall be payable;
(v) The redemption rights and price or prices, if any, for shares of the series;
(vi) The terms and amount of any sinking fund provided for the purchase or redemption of shares of the series;
(vii) The amounts payable on and the preferences, if any, of shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Corporation;
(viii) Whether the shares of the series shall be convertible into or exchangeable for shares of any other class or series, or any other security, of the Corporation or any other corporation, and, if so, the specification of such other class or series of such other security, the conversion or exchange price or prices or rate or rates, any adjustments thereof, the date or dates at which such shares shall be convertible or exchangeable and all other terms and conditions upon which such conversion or exchange may be made;
(ix) Restrictions on the issuance of shares of the same series or of any other class or series;
(x) The voting rights, if any, of the holders of shares of the series.
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(c) Common Stock. The Common Stock shall be subject to the express terms of the Preferred Stock and any series thereof. Each share of Common Stock shall be equal to each other share of Common Stock. Except as may be provided in these Amended Articles of Incorporation or in a Preferred Stock Designation, the holders of shares of Common Stock shall be entitled to one vote for each such share upon all questions presented to the stockholders.
ARTICLE IV
The Board of Directors is hereby authorized to create and issue, whether or not in connection with the issuance and sale of any of stock or other securities or property of the Corporation, rights entitling the holders thereof to purchase from the Corporation shares of stock or other securities of the Corporation or any other corporation. The times at which and the terms upon which such rights are to be issued will be determined by the Board of Directors and set forth in the contracts or instruments that evidence such rights. The authority of the Board of Directors with respect to such rights shall include, but not be limited to, determination of the following:
(a) The initial purchase price per share or other unit of the stock or other securities or property to be purchased upon exercise of such rights.
(b) Provisions relating to the times at which and the circumstances under which such rights may be exercised or sold or otherwise transferred, either together with or separately from, any other stock or other securities of the Corporation.
(c) Provisions that adjust the number or exercise price of such rights or amount or nature of the stock or other securities or property receivable upon exercise of such rights in the event of a combination, split or recapitalization of any stock of the Corporation, a change in ownership of the Corporation’s stock or other securities or a reorganization, merger, consolidation, sale of assets or other occurrence relating to the Corporation or any stock of the Corporation, and provisions restricting the ability of the Corporation to enter into any such transaction absent an assumption by the other party or parties thereto of the obligations of the Corporation under such rights.
(d) Provisions that deny the holder of a specified percentage of the outstanding stock or other securities of the Corporation the right to exercise such rights and/or cause the rights held by such holder to become void.
(e) Provisions that permit the Corporation to redeem or exchange such rights.
(f) The appointment of a rights agent with respect to such rights.
ARTICLE V
(a) Subject to the rights of the holders of any series of Preferred Stock or any other series or class of stock as set forth in these Amended Articles of Incorporation, to elect additional directors under specified circumstances, the number of directors of the Corporation shall be fixed by the By-laws of the Corporation and may be increased or decreased from time to time in such a manner as may be prescribed by the By-laws.
(b) Unless and except to the extent that the By-laws of the Corporation shall so require, the election of directors of the Corporation need not be by written ballot.
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ARTICLE VI
The Corporation may in its By-laws confer powers upon the Board of Directors in addition to the foregoing and in addition to the powers and authorities expressly conferred upon the Board of Directors by applicable law.
ARTICLE VII
(a) Each person who is or was or had agreed to become a director or officer of the Corporation, or each such person who is or was serving or who had agreed to serve at the request of the Board of Directors or an officer of the Corporation as a director, officer or trustee of another corporation, partnership, joint venture, trust or other enterprise (including the heirs, executor, administrators or estate of such person), shall be indemnified by the Corporation, in accordance with the By-laws of the Corporation, to the fullest extent permitted from time to time by the N.R.S. as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than said law permitted the Corporation to provide prior to such amendment) or any other applicable laws as presently or hereafter in effect.
(b) The Corporation may, by action of the Board of Directors or through the adoption of By-laws, provide indemnification to employees and agents of the Corporation, and to persons serving as employees or agents of another corporation, partnership, joint venture, trust or other enterprise, at the request of the Corporation, with the same scope and effect as the foregoing indemnification of directors and officers. The Corporation shall be required to indemnify any person seeking indemnification in connection with a proceeding (or part thereof) initiated by such person only if such proceeding (or part thereof) was authorized by the Board of Directors or is a proceeding to enforce such person’s claim to indemnification pursuant to the rights granted by these Amended Articles of Incorporation or otherwise by the Corporation.
(c) The right to indemnification conferred in this Article VII shall be a contract right and shall include the right to be paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition, such advances to be paid by the Corporation within twenty (20) days after the receipt by the Corporation of a statement or statements from the claimant requesting such advance or advances from time to time; provided, however, that if the N.R.S. requires, the payment of such expenses incurred by such a person in his or her capacity as such a director or officer of the Corporation in advance of the final disposition of a proceeding, shall be made only upon delivery to the Corporation of an undertaking by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified under this Article VII or otherwise.
(d) Without limiting the generality or the effect of the foregoing, the Corporation may enter into one or more agreements with any person that provide for indemnification greater or different than that provided in this Article VII.
(e) Neither any amendment or repeal of any Section of this Article VII, nor the adoption of any provision of these Amended Articles of Incorporation or the By-laws of the Corporation inconsistent with this Article VII, shall adversely affect any right or protection of any director, officer, employee or other agent established pursuant to this Article VII existing at the time of such amendment, repeal or adoption of an inconsistent provision, including without limitation by eliminating or reducing the effect of this Article VII, for or in respect of any act, omission or other matter occurring, or any action or proceeding accruing or arising (or that, but for this Article VII, would accrue or arise), prior to such amendment, repeal or adoption of an inconsistent provision.
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ARTICLE VIII
(a) The liability of the directors of the Corporation for monetary damages shall be eliminated to the fullest extent permitted by the N.R.S., as now or hereafter in effect. If the N.R.S. is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated to the fullest extent permitted by the N.R.S., as so amended.
(b) Neither any amendment or repeal of any Section of this Article VIII, nor the adoption of any provision of these Amended Articles of Incorporation or the By-laws of the Corporation inconsistent with this Article VIII, shall adversely affect any right or protection of any director established pursuant to this Article VIII existing at the time of such amendment, repeal or adoption of an inconsistent provision, including without limitation by eliminating or reducing the effect of this Article VIII, for or in respect of any act, omission or other matter occurring, or any action or proceeding accruing or arising (or that, but for this Article VIII, would accrue or arise), prior to such amendment, repeal or adoption of an inconsistent provision.
ARTICLE IX
Except as may be expressly provided in these Amended Articles of Incorporation, the Corporation reserves the right at any time and from time to time to amend, alter, change or repeal any provision contained in these Amended Articles of Incorporation or a Preferred Stock Designation, and any other provisions authorized by the laws of the State of Nevada at the time in force may be added or inserted, in the manner now or thereafter prescribed herein or by applicable law, and all rights, preferences and privileges of whatsoever nature conferred upon stockholders, directors or any other persons whomsoever by and pursuant to these Amended Articles of Incorporation in its present form or as hereafter amended are granted subject to the right reserved in this Article IX; provided, however, that any amendment or repeal of Article VII or Article VIII of these Amended Articles of Incorporation shall not adversely affect any right or protection existing hereunder in respect of any act or omission occurring prior to such amendment or repeal; and provided further that no Preferred Stock Designation shall be amended after the issuance of any shares of the series of Preferred Stock created thereby, except in accordance with the terms of such Preferred Stock Designation and the requirements of applicable law.
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