Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis
August 11, 2014 -- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that the Company has just received the final toxicology report for Brilacidin-OM. Cellceutix is developing Brilacidin-OM as a new treatment for oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy.
Cellceutix is reviewing the report, which will be added to finalize the already prepared Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration seeking approval to commence a Phase 2 clinical trial of Brilacidin-OM as soon as possible.
“The past week was full of great news for us; that enrollment for the Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections will be completed this month, the statistical data on our anti-psoriasis drug Prurisol showed that it attained it’s primary endpoint in a Phase 1 trial, and now the data to complete the IND for Brilacidin-OM. We look forward to the IND submission in a bid to fill an area of great unmet medical need to the nearly half a million patients that suffer the painful effects of oral mucositis every year,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix.
Mr. Ehrlich added, “On a broader perspective, the question has been posed to me about what last week’s FDA approval of The Medicines Company’s oritavancin, a one-time treatment for ABSSSI, means to Brilacidin. First, we congratulate The Medicines Company on their approval. Candidly, we do not view oritavancin as a potential competitor to our Brilacidin because of several key differentiators, namely pharmacokinetic profiles and subsequent implications. Ortavancin is a lipoglycopeptide, the same class of drug as Durata Pharmaceutical’s Dalvance®
(Dalbavancin), and both drugs have a very long half-life of approximately one to two weeks. This means that the drug remains in a patient’s system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance. Brilacidin, a new class of drug, has a half-life of only 13 to 16 hours, a time frame that we believe is ideal for a one-time treatment, while greatly decreasing the chance of resistance developing. Further, Brilacidin in its clinical trials is being tested compared to daptomycin, a superior drug to vancomycin, which was the comparator arm in the pivotal trials of ortavancin and Dalvance. Overall, in addition to the direct comparison with ABSSSI, we look at our asset as offering much more potential as an antibiotic, especially with room temperature formulations paving the way for possibly treating a wide range of other indications, such as diabetic foot ulcer infections, ophthalmic infections and otitis media. ABSSSI alone is more than a billion-dollar market and growing, and there is room for everyone with the best drug taking the lion’s share of dollar sales. So while we applaud a new therapeutic option for patients, we are not concerned about the approval of ortavancin.”
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 has recently completed a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, is in a Phase 2b trial 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.
Source: Cellceutix Corporation
Posted: August 2014