BEVERLY, MA–(Marketwired – Jan 5, 2015) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to release additional statistics from the Company’s recent, successfully completed Phase 2b trial of Brilacidin, Cellceutix’s lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The FDA-defined primary endpoint of at least 20% reduction in area of the ABSSSI lesion, relative to baseline, was achieved in all study populations at 48-72 hours, for each of the three Brilacidin dosing regimens and the active comparator, daptomycin.
In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively.
The corresponding 95% confidence intervals around the clinical success rates were 85-100%, 90-100%, 94-100%, and 87-100%, respectively. It is important to note that this Phase 2b study was not powered for statistical comparisons. Nevertheless, because the 95% confidence intervals overlap, these clinical success rates are considered similar. Regulators prefer the use of 95% confidence intervals, rather than p-values, when comparing efficacy rates in clinical trials, as they can provide more information than p-values. A much larger study — such as the kind done in phase 3 — would have the power to make statistical comparisons.
On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals).
“These results are outstanding across all dosing regimens,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. ”The Phase 2 data showing a one-time dose of Brilacidin achieving statistically comparable results to a seven-day dosing regimen for the current gold standard treatment for ABSSSI is fantastic and reason for great optimism going forward.”
Additional updates on Brilacidin and other drugs in the Cellceutix pipeline will be given at the Biotech Showcase 2015 conference being held at Parc 55 Wyndham San Francisco (Union Square) in San Francisco, CA on January 12-14, 2015. Cellceutix will be presenting at the conference on Monday, January 12 at 2:00 PM PT in Room Powell.