EXTON, Pa., May 13 /PRNewswire-FirstCall/ -- Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the initiation of a small histology study (IT-H-001) of azficel-T, an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment of approximately 20 participants from the completed and statistically significant pivotal Phase III studies of azficel-T (IT-R-005 and IT-R-006).
The FDA requested the comparative histological data from this study in a Complete Response letter issued to the Company on December 21, 2009 related to the Biologics License Application (BLA) for azficel-T for the treatment of moderate to severe nasolabial fold wrinkles in adults.
The histology study will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.
"Over the past several months, we have worked closely with the FDA and our clinical investigators to design this study protocol," said David Pernock, Chairman and CEO, Fibrocell Science Inc. "We intend to submit data from the study to the FDA in the fourth quarter of 2010."
According to milestones established in the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem Fibrocell's response to their letter complete.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTC Bulletin Board: 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 in this press release include, without limitation, the ability of the Company to submit data from the study to the FDA in the fourth quarter of 2010 as part of its Complete Response and the timely acceptance by the FDA of the Company's Complete Response. 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.
SOURCE Fibrocell Science, Inc.
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The FDA requested the comparative histological data from this study in a Complete Response letter issued to the Company on December 21, 2009 related to the Biologics License Application (BLA) for azficel-T for the treatment of moderate to severe nasolabial fold wrinkles in adults.
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The histology study will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.
"Over the past several months, we have worked closely with the FDA and our clinical investigators to design this study protocol," said David Pernock, Chairman and CEO, Fibrocell Science Inc. "We intend to submit data from the study to the FDA in the fourth quarter of 2010."
According to milestones established in the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem Fibrocell's response to their letter complete.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTC Bulletin Board: 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 in this press release include, without limitation, the ability of the Company to submit data from the study to the FDA in the fourth quarter of 2010 as part of its Complete Response and the timely acceptance by the FDA of the Company's Complete Response. 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.
SOURCE Fibrocell Science, Inc.
