EXTON, Pa.--(BUSINESS WIRE)--Fibrocell Science, Inc. (OTC:FCSCD) announced today the initiation of a Phase II trial for azficel-T, an autologous fibroblast cellular product, for the treatment of restrictive burn scars (RBS).
The Phase II double-blind, randomized, placebo-controlled study will enroll 21 participants with burn scars that restrict range of motion of jointed areas such as elbows, shoulders and fingers. The study is led by Daniel D. Lozano, M.D., M.B.A., Chief of Burn Surgery at Lehigh Valley Health Network’s Burn Center in Allentown, Pa. Lehigh Valley Burn Center is one of 63 burn centers in the U.S. verified by the American Burn Association and American College of Surgeons for providing high quality care to patients from time of their injury through rehabilitation, and it is Pennsylvania's largest and busiest burn center.
Restrictive burn scars represent an unmet medical need with no existing FDA-approved drugs. Approximately 45,000 burn victims are hospitalized every year in the U.S. This estimate does not include military personnel and does not take into account the large pool of victims with existing burns.1 About half of hospitalized burn patients will develop some restrictive scarring.2
Measurement scales will assess range of motion (ROM), brief pain index and scar appearance. Primary efficacy and safety endpoints will be evaluated six months after patients are administered azficel-T or placebo.
“Restrictive burn scars over joints can lead to a reduction in range of motion and may cause significant pain and discomfort for the patient. This category of scarring can adversely impact the patient’s quality of life,” said Lozano. “A treatment using an individual’s own fibroblast cells provides the potential for a truly biologic, non-surgical approach to treat restrictive scars.”
As one of only three cell-based products approved by the FDA, azficel-T (LAVIV®) is the first and only approved for aesthetic use that utilizes a patient’s own cells. This same technology is being evaluated in this Phase II trial for treating restrictive burn scars. Current standard of care for RBS is surgery or lasers.
“We believe leveraging the technology of LAVIV will help us address high-value, unmet medical needs,” said David Pernock, Chairman and CEO of Fibrocell Science, Inc. “In addition to the aesthetic benefits of autologous fibroblasts, we are encouraged by their potential for the treatment of restrictive burn scarring. Patients have experienced the functional benefits of fibroblasts in individual case studies and we hope to confirm those benefits in the Phase II trial.”
Fibroblast cells make collagen, a protein that gives skin its strength and elasticity. LAVIV is the first and only autologous fibroblast cellular product approved by the FDA to improve the appearance of moderate to severe nasolabial fold (smile line) wrinkles in adults. It has been evaluated in more than 1,000 patients in clinical studies, including two pivotal Phase III trials.
Separately, on Monday, April 29, 2013 Fibrocell announced a reverse split of its common shares of 25 shares to one. The shares started trading with the revised split on Tuesday, April 30, 2013. The Company said it has been cleared to submit a listing application to NYSE MKT.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (FCSCD) is an autologous cell therapy 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)
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 (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 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.
1 American Burn Association. www.ameriburn.org; Goodis. J and E.d. Schraga. Burns, thermal. eMedicine Journal.
2 Personal communications with several expert burn clinicians.