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Author Topic: CTIX -- Cellceutix Corporation
BooDog
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10-K

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.

Steps for up listing underway.

http://www.sec.gov/Archives/edgar/data/1355250/000147793214005027/ctix_10k.htm


Investment Conference, – Audio New York City, NY – Tuesday, September 9, 2014 CTIX Rodman 2014 Part 1 (1) CTIX Rodman 2014 Part 2 (1) - See more at: http://cellceutix.com/events/#sthash.BjqAe9Ny.dpuf


http://cellceutix.com/events/#sthash.BjqAe9Ny.dpbs

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BooDog
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2.38 close.

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BooDog
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CTIX news
http://cellceutix.com/cellceutix-to-president-obama-we-have-the-tools-and-will-r ise-up-to-the-challenge-to-prevent-antibiotic-resistant-bacteria-becoming-a-seri ous-threat-to-public-health/#sthash.tv6iAP4k.dpbs

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

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BooDog
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http://cellceutix.com/cellceutix-antibiotic-brilacidin-receives-qidp-designation -from-fda/#sthash.60YVYS9o.dpbs

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

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BooDog
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4.52 hod and still looking good.

4.52 1.17 34.93% 3,812,503 214.7K

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BooDog
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CTIX conference coming up on Monday.

I've still been flipping some of this along the way.

Added back in 3.82 Dec 17th

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BooDog
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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

Meeting:
2015 ASCO Annual Meeting

Abstract No:
TPS2613

Poster Board Number:
Board #323a

Citation:
J Clin Oncol 33:5s, 2015 (suppl; abstr TPS2613)

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

http://abstracts.asco.org/156/AbstView_156_149817.html


https://clinicaltrials.gov/show/NCT01664000 as well for reference.


CTIX has also moved on to the 11th cohort
http://cellceutix.com/cellceutix-reports-results-for-quarter-ended-march-31-2015 -enrollment-for-oral-mucositis-studies-to-begin-this-month/#sthash.k1mZ6uL6.dpbs

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BooDog
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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.

To access the webcast go to: http://psav.rampard.com/20150521/


web cast sponsored by Cellceutix, CoreMedix & NEXGEN Biosciences. starts 8am 5/21/15

webcast link
http://psav.rampard.com/20150521/reg.jsp


http://50.87.248.71/~cormedix/wp-content/uploads/2014/11/QIDP-Formal-Invite-2-43 5x1024.jpg

==============================================
Posted by 'farrell90'...

Power point presentation on CTIX web page.

http://cellceutix.com/wp-content/uploads/2014/06/QIDP_21May2015-Power-Point-Pres entation.pdf

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

===================================================

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BooDog
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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


ACO 2015 presentation by Dr. Shapiro

http://cellceutix.com/wp-content/uploads/2015/05/ASCO-2015-Poster-.-FINAL-1.pdf

http://cellceutix.com/asco-2015-a-phase-1-dose-escalation-safety-pharmacokinetic -pharmacodynamic-study-of-thioureidobutyronitrile-a-novel-p53-targeted-therapy-i n-patients-with-advanced-solid-tumors/#sthash.rJyxGqez.Ykj69KYo.dpbs

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BooDog
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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

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BooDog
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News
http://www.otcmarkets.com/news/otc-market-headline?id=283607

Like it.

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BooDog
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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.

Alerts:

Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?


term=cellceutix&Search=Search
- See more at: http://cellceutix.com/cellceutix-announces-brilacidin-data-to-be-presented-by-ic pd-at-the-joint-55th-interscience-conference-on-antimicrobial-agents-chemotherap y-icaac/#sthash.bYSdOKSX.dpuf

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BooDog
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poster
http://cellceutix.com/wp-content/uploads/2014/06/Population-Pharmacokinetics-PPK -of-Brilacidin-BRI-in-Healthy-Subjects-and-Patients-with-Acute-Bacterial-Skin-an d-Skin-Structure-Infections-ABSSSI-Poster-Walk.pdf

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BooDog
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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.



Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

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

http://finance.yahoo.com/news/cellceutix-completes-clinical-trial-kevetrin-14300 0660.html

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BooDog
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CTIX SA article,
nicely put together.
http://seekingalpha.com/article/3962308-cellceutix-still-flying-radar-innovative -biotech-tremendous-upside-potential

I don't condone half the crap SA puts out but this was nicely done.

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BooDog
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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.

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BooDog
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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

http://cellceutix.com/email-alerts/#sthash.pWCBhC9U.dpbs

About Prurisol

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.

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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 Company’s new website address will change to www.IPharmInc.com. In the interim, the Company will maintain www.cellceutix.com.

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

Presentation Type: Audio Webcast
Event Date: Thursday, June 8, 2017, at 11am EDT
Call-in Numbers: 866-682-6100 / 862-255-5401
Event Link: http://www.investorcalendar.com/event/15776

======================================================

Name change should be posted to The Daily List shortly.

http://otce.finra.org/DailyList

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.


Item 9.01 Financial Statements and Exhibits.


https://www.sec.gov/Archives/edgar/data/1355250/000147793217002710/ctix_8k.htm


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.


2


(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.

https://www.sec.gov/Archives/edgar/data/1355250/000147793217002710/ctix_ex31.htm

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All post are my opinion. Do your own DD. Who's clicking your buy/sell button!?

Posts: 7754 | From: Virginia | Registered: May 2006  |  IP: Logged | Report this post to a Moderator
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