SOURCE: Cellceutix

Cellceutix

June 01, 2015 08:10 ET

Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM For Oral Mucositis Expanding to Additional Centers

BEVERLY, MA--(Marketwired - June 01, 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 announce that last week a second site opened enrollment in the Company's Phase 2 clinical trial of Brilacidin-OM for the prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemoradiation. Clinical sites in Oregon and South Dakota are now enrolling patients to evaluate Brilacidin-OM for efficacy with additional sites to be added in June to keep the trial progressing in a timely manner.

More information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2.

Besides targeting the huge unmet medical need for an effective therapeutic for oral mucositis, the Brilacidin-OM trial has significant implications for Cellceutix shareholders. Should the anti-inflammatory properties of Brilacidin-OM work in the trial as anticipated, Cellceutix will immediately turn its attention to inflammatory diseases, such as hidradenitis suppurativa (HS) and gastrointestinal diseases, as planned. Cellceutix believes the potential market size for its defensin mimetics as anti-inflammatory compounds is even greater than the substantial market for antibiotic applications.

"We expect this trial of Brilacidin-OM to move efficiently and are very pleased to see another clinical site already open for enrolling patients," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "As this trial is underway we are completing the formulation work for treating hidradenitis suppurativa. Actually, the timing couldn't be better with the U.S. Food and Drug Administration recently granting AbbVie an orphan drug designation for HUMIRA® (adalimumab) for the investigational treatment of moderate-to-severe HS. The designation answered many questions for us and is certainly something we will apply for as well in order to try and shave millions of dollars and years off the clinical trials."

Cellceutix will be issuing a separate update on the events at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting shortly after its conclusion on Tuesday, June 2, 2015.

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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 has begun 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 has recently completed a Phase 1 clinical trial and is being readied for 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