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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.
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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
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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. .
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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.
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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. .
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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 .
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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 .
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Cellceutix Confident as Cancer Compound Shows Activity in All Cancers Tested Cellceutix Updates Shareholders; Answers Questions About Clinical Trials for Novel Cancer Drug
We'll see how it goes.
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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.
Site Navigation Home Our Team Product Pipeline Kevetrin™ Compound Prurisol Compound Autism Compound
Investors Press Releases In the News Events and Presentations Stock Information Financial Information Contact Us
Cellceutix
100 Cumming Center, Suite 151-B Beverly, MA 01915 Phone : 978-236-8717 Email: info@cellceutix.com
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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
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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.”
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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
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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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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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
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SUBJECT CODE: Pharmaceuticals and Biotech:Biotech
Pharmaceuticals and Biotech:Trials
Pharmaceuticals and Biotech:Equipment and Supplies
Pharmaceuticals and Biotech:Drugs
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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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.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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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."
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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