Cellceutix Provides Corporate Update - Seite 3

Brilacidin - Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

We are developing Brilacidin under a Qualified Infectious Disease Product (QIDP) designation from the FDA as a potential new and unique treatment for ABSSSI. In our completed 215-patient Phase 2b trial of Brilacidin ABSSSI, two different single dose treatments of Brilacidin, as well as a three-day regimen, were all shown to be comparably effective as the FDA-approved 7-day dosing regimen of the blockbuster antibiotic daptomycin. In 2014, daptomycin was marketed under that brand name Cubicin by Cubist Pharmaceuticals and generated $1.046 billion in sales. In December 2014, Merck & Co. agreed to acquire Cubist Pharmaceuticals for approximately $9.5 billion, including debt. 

We released the positive top-line data from the Phase 2b Brilacidin trial in October 2014. After our initial submission of data from this study to the FDA, the agency requested additional data from the trial. We have gathered microbiologic (MIC) data from bacterial pathogens isolated in the trial, analyzed pharmacokinetic (PK) data, performed pharmacodynamic (PD) modeling, and conducted in-depth evaluations of the safety profile of Brilacidin in comparison to daptomycin in this patient population. We anticipate meeting with the FDA for an End-of-Phase 2 meeting in late June 2015. Upon the FDA accepting our proposals, we will commence Phase 3 trials of Brilacidin for ABSSSI.

Brilacidin - Prevention or Attenuation of Oral Mucositis in Head and Neck Cancer

We are conducting a Phase 2 trial of Brilacidin oral rinse for the prevention or attenuation of oral mucositis (OM), a common and often debilitating inflammation and ulceration condition that occurs in the mouth as a side effect of chemotherapy and radiation therapy for head and neck cancer. Approximately 450,000 patients each year in the United States experience OM, which affects the course and outcome of cancer therapy. Pre-clinical studies in an animal model indicate that the antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin can potentially provide a strong therapeutic benefit to OM patients. The FDA accepted our Investigational New Drug application in October 2014 to begin the trial. Since that time, we made modifications to target specific investigator sites having significant experience in conduct of this type of study and ultimately doubled the original number of planned sites to expedite recruitment. We expect subject enrollment in this trial to commence in May. OM represents a great area of unmet medical need and is potentially a very important and valuable asset in the Brilacidin development pathway.