Fibrocell Science, Inc. to Initiate Phase II Clinical Trial for Restrictive Burn Scars
Fibrocell Science, Inc. to Initiate Phase II Clinical Trial for Restrictive Burn Scars
EXTON, Pa.--(BUSINESS WIRE)-- Fibrocell Science, Inc., a biotechnology company at the forefront of research into the potential medical and aesthetic use of fibroblasts, plans to initiate a Phase II clinical trial to assess the potential of azficel-T for treating restrictive burn scars in first quarter, 2013. Fibroblasts are skin cells responsible for the production of collagen that contribute to the formation of connective tissue fibers. The company recently launched LAVIV® (azficel-T), the first and only personalized cell treatment approved by the FDA to improve the appearance of moderate to severe nasolabial folds or "smile line" wrinkles in adults.
Azficel-T has been evaluated in over 1,000 patients in well controlled clinical studies, including two pivotal Phase III trials for licensed application. The restrictive burn scar trial will enroll 20 subjects who have unilateral restrictive burn scars of a jointed area, such as elbows, shoulders and fingers. Measurement scales will assess Range of Motion (ROM), Brief Pain Index and Scar Appearance.
Approximately 45,000 people in the U.S. are hospitalized each year with severe burns.1 These patients are often left with restrictive burn scars that decrease mobility and cause continuous pain. "Indications are that fibroblasts, due to their inherent role in wound healing, have the potential to bring an increased quality of life to those patients who have long suffered from restrictive burn scars," said Daniel Lozano, MD, principal investigator for the study. "This clinical trial has the potential to help validate this concept and bring physicians an effective treatment option for their patients."
"This is an important step for Fibrocell Science," said David Pernock, Chairman and CEO of Fibrocell Science, Inc. "The clinical trial is part of the Company's strategic plan to use its proprietary, collagen-producing fibroblast platform to address high-value, unmet medical needs."
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, Inc. 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)
LAVIV is indicated for use for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
Important Safety Information
LAVIV® (azficel-T) is an autologous cellular product for intradermal injection only. LAVIV is contraindicated for allogeneic use, in patients with allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO) or material of bovine origin and in patients with active infection in the facial area. The following reactions have been reported following treatment with LAVIV: hypersensitivity reactions, bleeding and bruising at the treatment site, vasculitis, herpes labialis, basal cell cancer; keloid and hypertrophic scarring may occur following post-auricular skin biopsies or LAVIV injections. Additional warnings and precautions to be considered include the use of LAVIV in patients with genetic disorders or formation of normal collagen matrices and in immunosuppressed patients, or those patients undergoing chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases.
The most common adverse reactions, occurring in ≥1% of patients who receive LAVIV, were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis and pruritus. For more information about LAVIV, please see accompanying full Prescribing Information or visit www.mylaviv.com.
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, Inc. on the treatment process. A list of trained and certified physicians is available at www.mylaviv.com and will be continually updated as new physicians are trained and begin offering LAVIV in their practice.
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 Company's ability to initiate a Phase II clinical trial to assess the potential of azficel-T for treating restrictive burn scars in the first quarter of 2013. 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, 2011, 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.
1 American Burn Association. www.ameriburn.org; Goodis. J and E.d. Schraga. Burns, thermal. eMedicine Journal.
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