BEVERLY, MA -- (Marketwired) -- 08/04/14 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to inform shareholders that it expects completion of enrollment in its Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections ("ABSSSI"), by the end of this month. Brilacidin is Cellceutix's lead antibiotic drug candidate in a new class of compounds called defensin-mimetics. Brilacidin is designed to act as a synthetic version of the naturally occurring defensins, peptides with antimicrobial activities that have been part of the innate immune response throughout evolution. By disrupting the structural integrity of bacteria, as opposed to interfering via a biochemical approach as most classes of antibiotics do, Brilacidin has an intrinsic ability to avoid the development of resistance.
The randomized, double-blind trial is evaluating short-course therapies of Brilacidin, which is being administered in two different single-dose treatments and a three-day dosing therapy, as compared to the standard once daily for seven days dosing regimen of daptomycin, (Cubicin®). Currently, the benchmark for the shortest-course antibiotic therapy approved by the FDA for ABSSSI is six days, obtained by Cubist Pharmaceuticals recently with the approval of Sivextro (tedizolid phosphate) on June 20, 2014.
Cellceutix would like to share a quote from a recent speech in Washington, D.C. by the Centers for Disease Control and Prevention Director Dr. Tom Frieden. "If we are not careful we will soon be in a post-antibiotic era, and for some patients and some microbes we are already there," said Dr. Frieden. "Every day we delay means it will be harder and more expensive to fix this problem in the long run."
"Dr. Frieden has been leader amongst a growing choir of government and world organization voices stressing the importance of bringing new antibiotics to market to curb a rising trend of bacterial infections that are estimated to cost the U.S. $55 billion annually in healthcare spending and lost productivity," said Leo Ehrlich, Chief Executive Officer of Cellceutix. "There is no future with the phrase 'post-antibiotic era' if we have anything to say about it. We believe that there are three key components in developing the next blockbuster antibiotic to help avoid entering a 'post-antibiotic era': an intrinsic ability to avoid the development of resistance; efficacy against current multi-drug resistant bacterium; and a short-course, preferably one dose, therapy. Research previously completed on Brilacidin suggests that the mechanism of action of this novel drug makes it possible to accomplish all these very challenging objectives."
"This is very exciting time as we have made significant clinical advancements with multiple drug candidates. Notably, we are nearing completion of the Phase 2b trial of Brilacidin, which we hope can one day set the new standard for rapid treatment of ABSSSI as well as other infections," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "I am extremely proud of our team and the outstanding job it has done in building Cellceutix a diversified portfolio of very promising drugs addressing many areas of great unmet medical need. We are hopeful that in just a few short weeks the capabilities and potential of Cellceutix compounds will become even more known in the scientific, academic and investment communities."
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.