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Fibrocell Science, Inc. Submits Final Data from Histology Study to FDA

^{Published on 2011-03-16 05:10:52 - Market Wire}
 

EXTON, Pa.--([ BUSINESS WIRE ])--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 Companya™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 Fibrocella™s response to the CR letter, and we believe we have met FDA requirements."

The Companya™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.

aThe submission of the final study report is a significant milestone for our lead cell therapy, azficel-T,a said David Pernock, Fibrocell Science Chairman and CEO.

aThis 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,a 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 Fibrocella™s response to the CR letter, and we believe we have met FDA requirements.a

About 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 Sciencea™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 ].

Forward-Looking Statements

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.