Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

BEVERLY, MA--(Marketwired - Aug 19, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its Phase 2b trial comparing Brilacidin™ to daptomycin (Cubicin®) in patients with acute bacterial skin and skin structure infections (ABSSSI). Overall, 215 patients were randomized to one of three dosing regimens of Brilacidin (single dose 0.6mg/kg; single-dose 0.8mg/kg; 1.2mg/kg over 3 days) or 7 days of once daily daptomycin. 

Brilacidin is the lead compound among a novel class of antibiotics known as defensin-mimetics. These compounds have shown great promise in preclinical and early clinical studies as potent antibiotics that can kill Staph aureus, including methicillin-resistant Staph aureus (MRSA). Moreover, given the unique mechanism of action, among other attributes, there is low, if any, potential for the development of resistance. Finally, the results of the current study may demonstrate that Brilacidin could be given as a single-dose, which provides benefits for both patients and society. 

This combination of properties makes Brilacidin unique among antibiotics recently approved or in development for the treatment of MRSA. Because these other compounds come from existing classes of antibiotics, there is the potential for cross-resistance; this is not the case for Brilacidin. 

"This is an important milestone for Cellceutix and for the field of infectious diseases," said Leo Ehrlich, the company's CEO. "There is no other antibiotic with these properties, which can treat infection and potentially decrease the burden of antibiotic resistance. Resistance, the antibiotic slayer. We are now in the process of manufacturing 30 kg of Brilacidin for future clinical trials which we plan for multiple forms of serious infections."

The company expects data from the trial to be available in the fourth quarter of 2014.

About Cellceutix:
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 Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed enrollment 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 most 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.