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     396  0 Kommentare Cellceutix Institutes "Database Soft Lock" on Its Phase 2 Psoriasis Clinical Trial, Top Line Results Anticipated in May; Additional Company Updates

    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.

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    Cellceutix Institutes "Database Soft Lock" on Its Phase 2 Psoriasis Clinical Trial, Top Line Results Anticipated in May; Additional Company Updates 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, …