Cellceutix Files with FDA for Phase 2b Clinical Trial of Novel Antibiotic Brilacidin
BEVERLY, MA—February 3, 2014 –Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the protocol for the Phase 2b trial of Brilacidin, Cellceutix’s lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics, was sent to the U.S. Food and Drug Administration.
Also, the Company’s submission to ClinicalTrials.gov for this upcoming Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) has been accepted. Cellceutix has been advised that the Brilacidin for ABSSSI trial will appear on www.ClinicalTrials.gov within two business days.
Cellceutix anticipates that trial recruitment of patients will begin mid-February.
The Phase 2b clinical trial will be evaluating Brilacidin as compared to the FDA-approved drug daptomycin in patients with ABSSSI caused by S. aureus and Strep pyogenes. Brilacidin will be administered in one-day and three-day dosing regimens, dosing schedules that are shorter than those of currently marketed antibiotics.
“We are within a few weeks of a milestone moment for our Company with the commencement of the Brilacidin trial for ABSSSI,” comments Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have made it very clear that we have high expectations for Brilacidin ever since we acquired it in September. I am very proud of the commitment and efficiency of our team, which in less than five months, completed requisite lab work and regulatory filings to have this important clinical trial ready to begin. With optimized dosing, we believe that Brilacidin can represent a major breakthrough in the field of antibiotics. ”
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 set to begin a Phase 2b trial in February 2014 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
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.
Posted: February 2014