Fibrocell Science, Inc. (OTCBB: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted a final study report to the U.S. Food & Drug Administration (FDA) for a completed, six-month histological study examining skin after injections of azficel-T. This study was a requirement in the Complete Response (CR) letter issued by FDA regarding the Company's Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. In December of 2010, the Company submitted data from a three-month assessment for this study. The Company has a PDUFA action date of June 22, 2011 for this BLA.
“The detailed microscopic analysis of tissue treated with azficel-T during this study support Fibrocell's response to the CR letter, and we believe we have met FDA requirements.”
The Company's final study report contained data from the 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol and data analysis plans. As was the case with the three-month report, there were no unexpected results in the six-month report, and the study provided additional data to support the azficel-T safety profile seen in the clinic.
"The submission of the final study report is a significant milestone for our lead cell therapy, azficel-T," said David Pernock, Fibrocell Science Chairman and CEO.
"This study, which objectively evaluated the effect of repeated azficel-T injections at three months and six months, has met all expectations. As anticipated from the extensive prior clinical experience, no clinical concerns were identified by either direct or comparative observations of the cellular morphology and integrity of the dermis, subcutis, or epidermis when biopsies from tissue treated with azficel-T were compared with either placebo-treated or untreated tissue," said James Merritt, M.D., Clinical Advisor to the study and Chief Medical Officer of CBR International Corp., a Colorado based research firm who provided medical advice to Fibrocell during the study. "The detailed microscopic analysis of tissue treated with azficel-T during this study support Fibrocell's response to the CR letter, and we believe we have met FDA requirements."
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