EXTON, Pa.--(BUSINESS WIRE)--Fibrocell Science, Inc. (OTCBB:FCSC.OB), a cell therapy company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s Biologics License Application for its lead product, laVív® (azficel-T) late last night. laVív is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. In clinical trials, laVív was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week.
The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person’s own skin cells (fibroblasts) to create laVív, which is then injected into the patient to improve the appearance of smile lines. In normal skin, fibroblasts are responsible for producing collagen.
“The concept of using a patient’s own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,” said Dr. Robert A. Weiss, Clinical Associate Professor, Johns Hopkins School of Medicine and Director, Maryland Laser Skin & Vein Institute, and an investigator for the laVív clinical trials. “Since this is a biological process that works over time, laVív is able to provide gradual and natural-looking results.”
The FDA approval was based in part on the combined results of two identical Phase III multi-center, randomized, double-blind, placebo-controlled studies of 421 patients. Treatment was administered in three sessions approximately five weeks apart. Using stringent co-primary endpoints based on the investigators’ and patients’ assessments, a significantly greater proportion of patients demonstrated a positive response to treatment with laVív than with placebo. Based on these trials, laVív effectively improved the appearance of nasolabial fold wrinkles for the six months of patient follow-up after the third and final treatment. How long the effect may last beyond six months is a topic of further study.
In clinical trials, the most common adverse reactions were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus.
To fulfill a post marketing requirement, and as part of the company’s on-going commitment to patients, Fibrocell will establish a registry of approximately 2,700 patients to further evaluate the safety of this autologous cell therapy.
“laVív is likely to appeal to patients who want to take a very new approach to treating wrinkles,” said Dr. Stacy Smith, Associate Clinical Professor in the Division of Dermatology at the University of California, San Diego, and investigator for the laVív clinical trials. “By injecting tens of millions of the person’s own fibroblasts, patients now have the option to help smooth smile lines by adding cells to replace those that may have been lost through the aging process.”
“We are delighted to achieve this milestone with laVív and provide patients with an innovative and highly personalized way to treat smile lines,” said David Pernock, Fibrocell Science Chairman and CEO. “This approval has been in the making for some time, and it would not have been possible without the dedication of our employees, clinical investigators and our clinical, regulatory and scientific advisors at CBR International.”
laVív will soon be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well.
About laVív® (azficel-T)
Each person’s laVív treatment is unique because it is made from their own cells. Small fibroblast samples are taken from behind the patient’s ear and sent to the Fibrocell Science lab. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of laVív administration is a series of three treatments, typically three to six weeks apart.
Additional information about laVív, including complete Prescribing Information, will be available on www.mylaviv.com within the coming days.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB:FCSC.OB) is a cell therapy company focused on the development of autologous (personalized) 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, the future appeal of laVív, the Company’s ability to increase manufacturing, to increase the number of physicians trained and to expand the number of cities served. 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, 2010, 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.
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