Studies Show LAVIV (azficel-T) Effectively Improves the Appearance of Smile Line Wrinkles
-Pivotal Trial Data Presented at American Society of Dermatologic Surgery Annual Meeting-
EXTON, Pa.--Nov. 7, 2011--(BUSINESS WIRE)--Fibrocell Science, Inc.
(OTCBB:FCSC), an autologous cellular therapeutic company focused on
the development of innovative products for aesthetic, medical and
scientific applications, announced that clinical trial data
demonstrating the effectiveness of LAVIV™ (azficel-T) for the
improvement of the appearance of moderate-to-severe nasolabial fold
wrinkles (“smile lines”) was presented late Friday
afternoon at the 2011 American Society of Dermatologic Surgery
Annual Meeting in Washington, D.C. LAVIV is a breakthrough new
treatment for “smile line” wrinkles made from a
person’s own collagen producing skin cells and is the first
and only personalized cell therapy approved by the FDA for
aesthetic use.
Study investigator Stacy Smith, M.D., presented results from secondary analyses of data from treated patients who participated in two pivotal LAVIV clinical studies, showing that 64% and 78% of patients treated with LAVIV experienced one-point improvements on the 6-point investigator scale and 5-point patient assessment scale, respectively, when assessed six months after completing LAVIV study treatment. Placebo rates were 36% and 48%, respectively.
Dr. Smith also presented the results of the co-primary efficacy assessments from these studies; the same data that are used in the FDA-approved Prescribing Information for LAVIV. The co-primary efficacy analyses required a robust two-point improvement in both assessments. Based on this standard, 30% of subjects who received at least one LAVIV injection had a two-point improvement in the appearance of smile lines six months after completing treatment, as rated by investigators, versus 8% for placebo. In self-assessments, 59% of patients reported a two-point improvement on a 5-point scale six months after completing treatment, versus 26% for placebo.
“LAVIV is a first of its kind treatment that works by expanding a patient’s own collagen-producing fibroblast cells. This data confirms the effectiveness of this innovative cell therapy,” said Dr. Smith, Associate Clinical Professor in the Division of Dermatology at the University of California, San Diego. “Since LAVIV is made from a patient’s own collagen-producing fibroblast cells, the safety profile is excellent,” he added.
In the safety data from the studies presented at ASDS, the most common adverse events were mild to moderate injection site reactions. Adverse events reported by more than 1% of patients treated with LAVIV included injection site redness (20%), swelling (12%), bleeding (6%), bruising (4%), papules (3%), pain (3%), and irritation (2%). Ninety-four percent (94%) of all adverse events reported by patients treated with LAVIV resolved within one week. In a microscopic analysis of the skin in the injected area, cells characteristic of mild inflammation were seen in 50% of samples treated with LAVIV, but no evidence of significant adverse changes was observed.
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, which is then injected into smile line wrinkles. Each person’s formulation of LAVIV is unique because it is made from their own fibroblast cells.
“We are delighted to share the results of the rigorously-designed LAVIV clinical trials to showcase the efficacy and safety of this innovative and highly personalized way to treat smile lines,” said David Pernock, Fibrocell Science Chairman and CEO.
About the Studies
The two, identical, Phase III multi-center, randomized, double-blind, placebo-controlled studies randomized 421 patients to receive LAVIV or placebo. The data presented at ASDS are from the modified-intent-to-treat analysis, which included 372 treated patients. Treatment was administered in three sessions approximately five weeks apart. Product efficacy was assessed by both patients and evaluating physicians. A subset of patients from these studies provided tissue samples for a histology analysis, which provided information about the skin after treatment on a cellular level. Safety data reported from this study were consistent with the adverse event profile established for LAVIV in previous clinical studies.
Data from these studies that supported approval and appear in the LAVIV Prescribing Information are from the more conservative intent-to-treat population, which included all 421 patients, regardless of whether or not they received treatment.
About LAVIV™ (azficel-T)
LAVIV was approved by the FDA on June 21, 2011, for the improvement of the appearance of moderate-to- severe nasolabial fold (smile line) wrinkles in adults. LAVIV is now available in major metropolitan areas throughout the U.S., exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science on the treatment process. A list of trained and certified physicians will soon be available at www.mylaviv.com and will be continually updated as new physicians are trained and begin offering LAVIV in their practice.
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. 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) 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.
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. 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
