Completion of Enrollment in Phase 2b Trial for Acute Bacterial Skin and Skin Structure Infections Expected this Month
BEVERLY, MA–(Marketwired – August 4, 2014) – 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.”