LAVIV (azficel-T) Demonstrates Improvement in Acne Scarring
New Data Show Personalized Cell Therapy Offers Potential New Treatment Approach
EXTON, Pa.--(BUSINESS WIRE)--Nov 3, 2011 - Fibrocell Science, Inc. (OTCBB:FCSC.OB), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, today announced the first scientific presentation of data demonstrating the efficacy of LAVIV™ (azficel-T) in treating moderate-to-severe depressed acne scars. The data were presented at the American Society for Dermatologic Surgery (ASDS) annual meeting in Washington, D.C. LAVIV, which is made from a person's own collagen-producing skin cells, is the first and only personalized cell therapy approved by the FDA for aesthetic use and was recently approved for the improvement of the appearance of moderate-to-severe “smile line” wrinkles (nasolabial folds). LAVIV is being investigated for the treatment of rolling, depressed acne scars, but is not currently approved for this indication.
According to the American Academy of Dermatology, about 40 to 50 million Americans have acne at any one time. Rolling acne scars are caused by damage under the surface of the skin and appear as soft, saucer-like depressions or pits on the skin. The skin typically loses its underlying support and develops a wavy texture. The scars tend to be wide and shallow. Research shows that facial acne scarring is common and affects men and women equally, occurring to some degree in 95 percent of acne cases. In this study, LAVIV was injected into the facial acne scars of patients to smooth the skin depressions.
The study successfully met its two prospectively defined co-primary endpoints: a 2-point or greater improvement on a 5-point Subject Live Acne Scarring assessment scale and a 1-point or greater reduction in cheek acne severity on a physician-assessed, validated 5-point Evaluator Live Acne Scar assessment scale. Final assessments were conducted four months after completing the study treatment regimen.
“Common approaches to treat acne scarring such as laser and fractional resurfacing can lead to prolonged downtime or unpredictable pigmentary complications of the skin,” said Girish (Gilly) Munavalli, M.D., Medical Director, Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC, Assistant Professor of Dermatology at Wake Forest University School of Medicine, and investigator for the study. “Our findings show that using a person's own collagen-producing cells in the form of LAVIV may provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile.”
According to the study results, a statistically significant higher percentage of subjects responded to treatment with LAVIV than with placebo, as rated by both the study investigators (58.7% vs. 42.2%; p=0.016) and patients (43.1% vs. 18.3%; p=0.000011) at the final assessment. Patient and Evaluator assessments at earlier time points during the study also showed a statistically significant higher proportion of responses with LAVIV than with placebo at all but one assessment.
All adverse events (AEs) reported during the study were mild or moderate in severity. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study as a result of an AE. The incidence of adverse events occurring in the treatment areas was comparable between LAVIV and placebo. The most common reported AEs were treatment area erythema (occurring in 11.1% of subjects) and swelling (occurring in 10.1% of subjects). Five of the 12 subjects reporting erythema and five of the 11 subjects reporting swelling had events of moderate severity in the LAVIV-treated area, whereas all treatment related AEs reported in the placebo-treated area were of mild severity. Other AEs reported during the study with a possible relationship to study treatment included bruising, rash, irritation, nodule, pain, acne, induration and headache. No clinically meaningful changes in vital signs or physical exam findings were reported.
The patented technology behind LAVIV is an advanced process that extracts a person's fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. In normal skin, fibroblasts are responsible for producing collagen. LAVIV is the resulting formulation of a person's own fibroblast cells. Each person's formulation of LAVIV is unique because it is made from their own cells.
“Fibrocell Science is committed to exploring the full therapeutic potential of our personalized fibroblast cellular treatment for use in diverse medical and aesthetic applications,” said David Pernock, Fibrocell Science Chairman and CEO. “We are encouraged by these data and look forward to further investigating the potential role of LAVIV in treating of acne scars.”
About the Study
The major clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, enrolling and collecting skin biopsies from 119 patients who had moderate-to-severe depressed acne scarring on both sides of the face for at least three years. Skin biopsies obtained from enrolled patients were used for fibroblast production. Patients served as their own controls. Ninety-nine of these patients received up to three injections with 2 mL autologous fibroblasts (10 - 20 million cells/mL) on one cheek and placebo (vehicle control; dye-free cell culture media) on the other at 14 day intervals. Treatment was administered at a dose of 0.1mL/cm2 into areas of acne scarring on the cheek, which were required have a scarred area of at least 9 cm2. Efficacy was assessed as described above. Safety was assessed based on the incidence of adverse events collected throughout the trial. Any injection site reactions or other localized adverse events were recorded independently for each side of the face, so that a comparison of adverse events by treatment could be performed.
Important Safety Information About LAVIV™ (azficel-T)
LAVIV (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
LAVIV is made especially for you from your own skin cells. Using someone else's cells can cause a serious reaction. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct.
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.
Your health care 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, 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. The full Prescribing Information for LAVIV includes additional warnings about adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these warnings.
Please 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.
For more information about LAVIV, please see the Full Prescribing Information at www.mylaviv.com.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB:FCSC.OB) 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.
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, whether LAVIV may in the future provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile. 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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Posted: November 2011