SOURCE: Cellceutix

Cellceutix

October 26, 2015 07:40 ET

Cellceutix to Request Meeting With FDA for Phase 2 Ovarian Cancer Study; Company's First-in-Human Study Defines the Pharmacokinetic Profile of Kevetrin

BEVERLY, MA--(Marketwired - October 26, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the Kevetrin trial for advanced solid tumors is providing important data on the pharmacokinetic (PK) profiles of the drug when administered in single doses over a wide range of concentrations and over differing durations of the intravenous infusion. This dose-ranging trial is near completion. We have collected enough data for planning Phase 2 trials. This data is being used to design the Kevetrin dosing regimen for the planned studies in patients with advanced ovarian carcinoma. The FDA meeting request is planned to be submitted this week.

To date, PK profiles found that the plasma half-life of Kevetrin is relatively short, supporting the projected administration of multiple infusions each week in the next study. The half-lives after the first dose and after the sixth dose do not differ appreciably.

Longer durations of Kevetrin infusion have shown prolonged exposure to the drug. Prolonged exposure and high area-under-the-curve (AUC) may be desirable in therapy of solid tumors especially with Kevetrin since activation of cell death signaling requires multiple gene synthesis and the phase or phases of the tumor cell cycle most susceptible to the effect(s) of Kevetrin is not known.

The Company has now gathered very valuable information from the Kevetrin Phase 1 study for planning mid-stage trials of Kevetrin. The PK data are reinforcing the Company's belief that with its short half-life, Kevetrin may provide an even greater therapeutic benefit with multiple weekly treatments. Since Kevetrin acts through transcription factor p53 and regulates many pro-apoptotic genes, the sustained exposure of Kevetrin is required to activate the apoptotic pathways in tumors. Cellceutix's goal is for the patient to have prolonged exposure to Kevetrin by dosing multiple times so that the tumor with different stages of mutations get ample time to activate the cell death signaling. As we have stated, we are now turning our attention to advance evaluation of Kevetrin in a Phase 2 study in patients with ovarian carcinoma for which Kevetrin was granted an orphan drug designation earlier this year. To help patients and develop the best medicines is why we the employees, with support from our shareholders, work so tirelessly at Cellceutix. We acknowledge the support and assistance of the Phase 1 trial's investigators at Dana Farber and Beth Israel Deaconess, including the pharmacokinetic laboratory, for lending their expertise in the development of our novel compound.

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Cellceutix clinical trials on Clinicaltrials.gov:

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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 antimicrobial 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 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 Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email contact