BEVERLY, MA -- (Marketwired) -- 07/07/14 -- Cellceutix (OTCQB: CTIX) announced another important milestone in the development of Brilacidin, the lead compound in a novel class of antibiotics known as defensin-mimetics. In the Company's phase 2b study on patients with acute bacterial skin and skin structure infections (ABSSSI), an independent Data Safety Monitoring Board (DSMB) gave a positive review of interim safety data, collected after approximately 50% of the subjects were enrolled. The DSMB is composed of two cardiologists, one neurologist, and one statistician, and its mandate is to monitor and promote the safety of study participants.
The DSMB recommended that Cellceutix continue the trial as planned. That is the best possible outcome. Independent experts did not observe any concerning safety signals in the study. In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.
Previous brilacidin phase 1 and 2 studies have indicated the drug is safe and effective in the treatment of ABSSSI caused by Staph aureus, including methicillin-resistant Staph aureus (MRSA). Any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug. However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg), and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg). Of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012.
Mr. Ehrlich commented, "Well this news confirms our initial opinions on Brilacidin's safety. Concerning Brilacidin's efficacy, we know from the earlier phase 2a study the drug is amazingly effective and can stand up to any potential competitor. Add in the facts that we are seeking a one-time dose regimen and the belief that antibiotic resistance to Brilacidin is highly unlikely to develop, we are very optimistic we have a winner. Brilacidin breaches the bacteria's cell wall. How do you build resistance to a bullet? Enrollment in the study is now approximately 80% complete. We look forward to the completion of the double-blind trial, which is anticipated in October, when we can then break the blind and see efficacy results as well as know if the existing drug safety profile continued throughout the remainder of enrollment. Add in the potential of Brilacidin for oral mucositis, diabetic foot ulcers, and eye and ear diseases, and you can understand what a game changer this drug alone brings to Cellceutix shareholders."
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 presently in 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.