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Cellceutix Selects Docetaxel for Combination Arm in Planned Phase 2 Trial for Ovarian Cancer


November 16, 2015 - Beverly, MA

BEVERLY, MA--(Marketwired - November 16, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today reports that, based upon ongoing laboratory studies, the Company intends to use docetaxel for the combination therapy arm in the planned Phase 2 clinical trial to treat patients with platinum-resistance ovarian cancer. Cellceutix is designing the multi-arm study to evaluate Kevetrin as a monotherapy and as a component of combination therapy.

In planning the combination therapy arm of the study, several different chemotherapies were tested with Kevetrin. Nude mice were implanted with a human ovarian cancer tumor. After tumors were established, mice were treated with 200 mg/kg of Kevetrin in combination with docetaxel at 15 or 30 mg/kg. Interim findings showed that mice treated with Kevetrin in combination with 15 mg/kg docetaxel exhibited a significant reduction in tumor growth. Kevetrin in combination with 30 mg/kg docetaxel further reduced tumor burden.

Cellceutix finds it encouraging that 6 of 10 tumors in the group treated with the combination of Kevetrin and 30 mg/kg docetaxel have been reduced to the point that they are not measurable.

The experiment is still ongoing. The determination of the final docetaxel dose has not yet been determined, as the Company needs to take into consideration docetaxel toxicity. The final data from the research will be used to support the planned Phase 2 trial, which remains subject to Food and Drug Administration (FDA) guidance and authorization to initiate the trial.

Alerts:

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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 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.

INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
Email contact

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