Fibrocell Science, Inc. Submits Clinical Study Report (CSR) to U.S. Food & Drug Administration for Phase II/III Trial of Azficel-T in Acne Scarring
EXTON, Pa., Aug. 9 /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 that it has submitted a clinical study report for its Phase II/III study of azficel-T for the treatment of moderate to severe acne scars to the U.S. Food & Drug Administration (FDA). The thorough analysis of study data contained in the report demonstrates that the study met all primary efficacy endpoints and was statistically significant, marking the submission as a significant regulatory milestone for the Company.
"This is an important step towards another potential indication for our azficel-T lead therapy, which is currently under review by the FDA for use in the treatment of nasolabial fold wrinkles," said Chairman and CEO David Pernock. "Our therapy would be the first product of its kind available to address the large unmet need in treatment of acne scars, if approved by FDA."
The Phase II/III, placebo-controlled study investigating the efficacy and safety of azficel-T for the treatment of moderate to severe acne scars evaluated a total of 109 individuals at seven U.S. clinical sites. In the study, both the Patient and Evaluator assessments met the co-primary endpoints four months after the final study treatment, and were statistically significant, achieving p-values of <0.0001 and 0.0109, respectively (p-values less than or equal to 0.05 are considered statistically significant).
With respect to the Patient assessments, 43 percent of patients reported a response to the side of the face treated with azficel-T four months after the final study treatment, while 18 percent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 percent of patients responded on the side of the face treated with azficel-T, and that 42 percent of patients responded on the placebo-treated side of the face. Notably, significant improvement was also observed as soon as one month after the final azficel-T treatment.
No serious adverse events related to azficel-T were reported during the course of the study. Similar to the results from previous studies with azficel-T, the occurrence of local adverse event in this study was low, and the events reported were mostly mild in nature and of short duration.
"This is a unique product and may be life changing for patients with acne scarring," said Girish Munavalli, M.D., MHS, Medical Director, Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina. "I remain extremely excited about the study results and the activity seen with the use of azficel-T to treat acne scars. Since the study concluded, some of the study patients have returned to my clinic. During these visits, I have noticed sustained improvement in the appearance of their scarring, which I believe is the result of the azficel-T treatment administered during the clinical trial. Based on these observations and my overall experience with azficel-T, I am very positive about the use of Fibrocell's product for this indication."
The goal of the Phase II/III multi-center, double-blind, randomized, placebo-controlled study was to demonstrate the efficacy of three injections of azficel-T on one side of the face as compared with placebo treatment on the other side of the face for the treatment of moderate to severe acne scars. The primary efficacy endpoints were measured four months following the last study treatment, using the following co-primary endpoints:
-- Patient Live Acne Scarring Assessment: The Patients' live assessment of the acne scarring of each cheek, using a 5-point assessment scale, with a response defined as a 2-point improvement as compared to baseline, and an
-- Evaluator Live Acne Scar Assessment: The Evaluators' live assessment of the acne scarring of the treatment area on each cheek, using a 5-point assessment scale and photoguide, with a response defined as a 1-point improvement as compared to baseline.
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. 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.