BEVERLY, MA--(Marketwired - April 19, 2016) - Cellceutix Corporation (
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.
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search
About Brilacidin
Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. Modeled after the body's innate host-defense response, Brilacidin kills bacteria quickly and efficiently, penetrating bacterial cell wall membranes. Given this mechanism-of-action, resistance is much less likely to develop. Beyond its robust antimicrobial properties, Brilacidin also functions in an immunomodulatory capacity, lessening inflammation and promoting healing.
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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 multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Contact Information:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich