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Fibrocell Science, Inc. is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications.
Welcome to the new Fibrocell Science, Inc. and our new web site. I am pleased to have this opportunity to share my enthusiasm with you as Fibrocell’s Chairman of the Board of Directors.
We have been extremely busy charting the course for Fibrocell as a biotechnology company focused on the power of regenerative fibroblast cells for aesthetic, medical and scientific applications.
We have a challenging and exciting path before us as we continue to prepare for the U.S. Food & Drug Administration response to the biologics license application (BLA) we submitted in March 2009 for the use of Laviv™ (azficel-T)*, Fibrocell Science’s lead therapy, for the treatment of moderate to severe nasolabial fold wrinkles. The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee, which reviewed our therapy on October 9, 2009, voted 11 yes to 3 no that the data presented demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication.
We are pleased to begin operations under Fibrocell Science, Inc., having reorganized the former Isolagen, Inc. and significantly reduced the company’s debt from US $81M to US $6M. We now look forward to an ambitious evaluation of our clinical priorities to maximize the potential use of our therapy in additional indications such as full-face rejuvenation, acne scars, burn scars and dental applications.
We have considerable work before us at Fibrocell Science, and we welcome the challenge. I join Fibrocell with extensive commercial experience from GlaxoSmithKline, where I most recently served as senior vice president, Pharmaceuticals and Vaccines. I am proud to have a strong management team helping guide this new company, including Declan Daly, former Isolagen chief executive officer, who was instrumental in our reorganization and remains committed to the company’s success.
Thank you for your interest in the new Fibrocell Science, Inc.
Sincerely,
David Pernock
Chairman
Fibrocell Science, Inc.
Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient’s own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells that contribute to the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin.
Broadly, the regenerative effects of fibroblasts include:
- The ability to synthesize the extracellular matrix components and, thus, to improve skin texture,
- The secretion of matrix fibers, including collagen, and
- Playing a critical role in wound healing and tissue repair.
The Company prepares the Fibrocell Therapy through a streamlined process that begins with removing a small sample of cells from behind a patient’s ear and sending that sample to the Fibrocell cGMP facility. The process expands fibroblasts into tens of millions of new cells, which are then formulated into an autologous cellular therapy. Cells are frozen and used for multiple treatment sessions. The therapy is reintroduced into the patient’s skin by injection, which we believe results in an increase in the local fibroblast population, collagen formation and assists the body’s own regenerative healing process. In controlled clinical studies, a significant improvement in the appearance of nasolabial fold wrinkles was observed after injecting Fibrocell Therapy.
Regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications. The Fibrocell Therapy for aesthetics, azficel-T, proposed brand name Laviv™, is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles. Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for azficel-T.
The company manufactures its cell therapy at a cGMP manufacturing facility in Pennsylvania.
Fibroblasts are cells that contribute to the formation of connective tissue fibers. Fibrocell's future scientific focus will be on regenerative medicine that leverages the direct and indirect therapeutic benefit of fibroblasts.
Fibrocell has submitted a biologics license application to the U.S. Food & Drug Administration (FDA) based on its Phase III clinical trials evaluating the efficacy and safety of its azficel-T in treating moderate to severe nasolabial fold wrinkles in patients older than 18 year of age.
In addition to wrinkle correction, Fibrocell has obtained statistically significant results in a Phase II/III acne scar clinical trial and a Phase II open label full face rejuvenation study. Fibrocell also has results in early burn scars and periodontal disease studies.
Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) is a biotechnology company focused on developing autologous cell therapies 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 its innovative cellular processing technology and manufacturing excellence.
Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Fibroblasts are cells that contribute to the formation of connective tissue fibers. The Fibrocell Therapy for aesthetics, azficel-T, proposed brand name Laviv™ is currently under review by the FDA for the treatment of moderate to severe nasolabial fold wrinkles.
Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for its Fibrocell Therapy, which is manufactured at a cGMP cell therapy manufacturing facility at its headquarters in Pennsylvania.
OCTOBER 09, 2009
Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
OCTOBER 06, 2009
Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
