BEVERLY, MA–(Marketwired – April 19, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the clinical database for Prurisol’s Phase 2 FDA trial for mild-to-moderate chronic plaque psoriasis has instituted a “Database Soft Lock.”
Also referred to as a “database freeze,” this step in the regulatory process means all case information has been compiled and put into the database and all known queries have been resolved. Next, the Quality Assurance staff will review all the data points to ensure statistical accuracy in preparation of the dataset’s final analysis and confirm that all data points, including PK data, are in-line with the Statistical Analysis Plan.
Additionally, the Company would like to provide the following updates:
FDA Feedback Received for Phase 3 Trial of Brilacidin-ABSSSI
Cellceutix has received a response from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Special Protocol Assessment (“SPA”) for its Phase 3 Trial of single-dose Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). The FDA reviewed the Company’s SPA submission and has requested certain changes be made to the protocol, as is typical procedure (see ‘About SPA Agreements‘ below). Cellceutix will be scheduling a meeting with the FDA to discuss the proposed protocol changes toward finalizing the agreement. Meanwhile, the Company is moving ahead in matters of clinical supply procurement and study sites selection.
About SPA Agreements
Obtaining Special Protocol Assessment (SPA) designation from the FDA is an important step as it reinforces the potential of a promising drug in clinical development. The SPA agreement delineates key statistical and clinical endpoint requirements, streamlining the process toward a product gaining FDA approval should the agreed upon criteria and outcomes be met. The SPA process itself can be iterative in nature. In fact, according to industry data, 78 percent of SPAs require multiple review cycles and an average of three months to finalize the SPA. For more information about the FDA’s SPA program, please visit:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.
“We are extremely proud of Brilacidin as it represents the first potential new class of antibiotics to treat serious skin infections in some twenty plus years and very much look forward to the start of the Phase 3 ABSSSI trial as soon as our SPA discussions with the FDA conclude,” stated Leo Ehrlich, Chief Executive Officer of Cellceutix. ”There is a huge unmet medical need, worldwide, for newer and better antibiotics, with the market likely to gravitate toward single-dose drugs like Brilacidin. Commonly praised by clinicians once introduced to it, Brilacidin is positioned to help fill this void, and in the process, further unlock shareholder value. In addition, we see the ABSSSI clinical trials as a gateway for Brilacidin’s use in bacterial biofilm infections and its use in the treatment of diabetic foot infections.”
Clinical Advisory Board Addition
Dr. Frances A. Farraye MD, MSc, has joined the Cellceutix Clinical Advisory Board. Dr. Farraye is Clinical Director in the Section of Gastroenterology and Co-Director of the Center for Digestive Disorders at Boston Medical Center. He is also Professor of Medicine at the Boston University School of Medicine. Prior to accepting the position, Dr. Farraye consulted with Cellceutix to help design the protocol for its planned Phase 2 ulcerative proctitis clinical trial. Commented CEO Leo Ehrlich, “We are thrilled to have Dr. Farraye formally join the Celleutix team. His expertise and leadership has been clearly demonstrated throughout his stellar career. Dr. Farraye’s experience and knowledge will help us explore Brilacidin’s potential in treating other gastroenterological conditions. Brilacidin continues to impress us as we explore its application in numerous clinical areas.”
About Dr. Francis A. Farraye, M.D., MSc.
Francis A. Farraye, M.D., MSc, Professor of Medicine, Clinical Director, Section of Gastroenterology and Co-Director, Center for Digestive Disorders, Boston University School of Medicine
Dr. Farraye is a Fellow of the American College of Physicians, American Society of Gastrointestinal Endoscopy, American Gastroenterological Association and the American College of Gastroenterology. He has published over 350 original manuscripts, abstracts and book chapters. He has served on numerous national and international committees including as a member of the ACG Board of Trustees. The New England CCFA named Dr. Farraye Humanitarian of the Year in 2003. In 2009, the ACG awarded Dr. Farraye the William Carey Award for service to the college. Dr. Farraye has been recognized as “Top Doctor” in Gastroenterology by Boston Magazine and U.S. News and World Report since 2010. His newest books for clinicians are Gastrointestinal Emergencies and Curbside Consultations in Inflammatory Bowel Disease and for patients Questions and Answers about Ulcerative Colitis, Questions and Answers about Crohn’s Disease and Ulcerative Colitis for Dummies.