Fibrocell Science Autologous Fibroblast Injections Show Improvement in Facial Acne Scar Appearance
Study Reporting Long-Term Improvement with No Lasting Adverse Effects Accepted for Publication in Dermatologic Surgery
EXTON, Pa.--(BUSINESS WIRE)-- Fibrocell Science, Inc. (OTC: FCSC) today announced that its Phase 2 study to evaluate the safety and efficacy of azficel-T (LAVIV®) for the treatment of patients with moderate-to-severe acne scars has been accepted for publication in Dermatologic Surgery, the peer-reviewed journal ofthe American Society for Dermatologic Surgery. The findings demonstrated that azficel-T treatment was associated with clinically meaningful improvement in acne scar appearance and was judged safe and superior to control treatment. The Early View (Online Version of Record) of the article is available at http://onlinelibrary.wiley.com/doi/10.1111/dsu.12204/pdf.
According to the American Academy of Dermatology, an estimated 20 million Americans have acne badly enough to cause scarring—a condition caused by damage that occurs under the skin's surface. Scars can appear as ice pick-like holes, or crater-like fixed or distensible depressions. The skin typically loses its underlying support and develops an uneven, poor texture.
David Pernock, CEO and Chairman of the Board, Fibrocell Science, stated, "We are pleased to report that the outcomes of this study correlate to clinically meaningful improvements in acne scar appearance. The study finds Fibrocell's autologous fibroblast treatment safe and superior to the placebo for the improvement in scar appearance."
Fibroblasts are cells that recreate collagen and other extracellular matrix proteins, which form the infrastructure of human tissue. Autologous fibroblasts are extracted from behind a patient's ear, harvested, and then re-injected at the site of the patient's acne scars.
"Of all skin changes possible after acne eruptions, scarring leaves the most potentially permanent, cosmetically and psychologically devastating effects," said lead investigator Gilly S. Munavalli, MD, MHS, FACMS, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC. "In this study, both patients and physicians reported significant improvements from the autologous fibroblast injections, so the research is very promising."
"Using a patient's own collagen-producing fibroblast cells to treat these wide, shallow acne scars makes so much sense," said Robert Weiss, MD, Maryland Laser, Skin and Vein Institute, Baltimore, MD, who was also an investigator in the multi-site, randomized, double-blind placebo-controlled study. "LAVIV has an excellent safety profile and there is minimal downtime, as well as a reduced risk of infection or adverse drug reactions."
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (FCSC) is an autologous cellular therapeutic company focused on the development of innovative products 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 as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.
About LAVIV® (azficel-T) from Fibrocell Science
LAVIV is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
Important Safety Information About LAVIV® (azficel-T)
LAVIV is made especially for you from your own skin cells. Using someone else's cells can cause a serious reaction. Do not let anyone else use your LAVIV. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct. Your healthcare provider will help you to decide whether you are a candidate for LAVIV and may help you avoid some of the adverse reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if you have any medical problems including allergic reactions to any drugs or food, bleeding disorders or take blood-thinning medicines like aspirin, ibuprofen, or COUMADIN® (warfare sodium), keloids or excessive scarring, skin cancer or any malignancy, genetic disorders affecting your skin, immune problems or take medicines that affect your immune system, or any other illness or medical problem. Tell your healthcare provider if you are allergic to the antibiotics amphotericin or gentamicin, bovine materials (products made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV if you have a skin infection on your face because LAVIV treatment can make the infection worse.
The most common side effects of LAVIV are at the injection-site, including redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness. In clinical trials with LAVIV, most injection-site adverse reactions resolved within one week and most required no treatment. There are additional adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these adverse reactions. For more information about LAVIV, please see full prescribing information.
For more information about LAVIV, please see the accompanying full Prescribing Information or visit www.mylaviv.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, 2012, 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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