Fibrocell Science, Inc. Submits Complete Response to FDA Regarding Azficel-T
EXTON, Pa.--(BUSINESS WIRE)--Dec 20, 2010 - 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 its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (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.
"The submission of our response to the FDA is a significant milestone for our lead cell therapy, azficel-T," said David Pernock, Fibrocell Science Chairman and CEO. "We believe that we have now satisfied all of the FDA requirements."
One of the FDA requirements was to conduct a histopathological study examining skin after injections of azficel-T. The Company's response contained data from a 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol, and consented to the unblinding of the study data. At three months, there were no unexpected results, and the study provided additional data to support the safety profile seen in the clinic.
"Azficel-T was directly compared to a placebo injection as well as untreated skin in each subject. The study results were consistent with previous clinical studies, while providing a detailed examination of azficel-T activity at the microscopic level after repeated injections," 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 study met all expectations, and importantly raised no safety concerns."
According to the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem that the response from Fibrocell Science is complete.
About The Fibrocell Science Technology
Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
Fibrocell Science's lead therapy, azficel-T, is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, our belief that we have satisfied all FDA requirements. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.