EXTON, Pa., Nov. 18, 2014 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced the U.S. Food and Drug Administration is allowing the company's investigational new drug (IND) application to proceed for developing a new treatment for amputee stump skin to prevent skin diseases that lead to prosthesis abandonment.
"We are proud and hopeful to play a role to develop a treatment that could potentially reduce the rate of prosthesis abandonment for those who have so honorably served our country, as my father did in the U.S. Marine Corps during World War II," said David Pernock, Chairman and Chief Executive Officer of Fibrocell.
By using autologous fibroblasts to help wounded warrior amputees, Fibrocell aims to address skin breakdown and pain at the stump site by promoting the skin properties found on the palms and soles. Specifically, autologous volar fibroblasts will be used to re-program non-palmar/plantar skin to develop a thickened stratum corneum and express keratin-9. If successful, this technique should reduce the rate of prosthesis abandonment in wounded warriors and other people with amputations.
To support development of this program, Fibrocell has collaborated with Lt. Col. Jon Meyerle, MD, of the Uniformed Services University of the Health Sciences in submission of an invited application to the Peer Reviewed Orthopaedic Research Program Clinical Trial Award (DoD/CDMRP/PRORP) Grant. This program is administered by the Congressionally Directed Medical Research Programs Office of the Department of Defense. Fibrocell would begin the program upon receipt of the grant.
"Prosthesis abandonment among amputees is due in large part to skin disease. We are working with Fibrocell on a clinical study to develop a novel treatment of amputee stump skin that could advance the quality of life of service members by improving the 'wearability' of their prosthetic devices," said Lt. Col. Meyerle, MD, Assistant Professor of Dermatology, USU, Residency Program Director, and Chief of Immunodermatology at Walter Reed National Military Medical Center.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (Nasdaq:FCSC) is an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs. Fibrocell's lead orphan drug program is in late-stage pre-clinical development for the treatment of RDEB (recessive dystrophic epidermolysis bullosa). Working in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology, Fibrocell is genetically modifying autologous fibroblast cells to express target proteins that are inactive or missing from patients with rare genetic skin and connective tissue disorders. Fibrocell is also pursuing medical applications for azficel-T—the Company's proprietary autologous fibroblast technology. Currently, the Company is in a Phase II clinical trial for vocal cord scarring. For additional information, visit fibrocellscience.com.
Forward-Looking Statements
This press release contains, and our officers and representatives may from time to time make, statements that are "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include, among others, statements we make regarding (i) our ability to develop a new treatment for amputee stump skin to prevent skin diseases that lead to prosthesis abandonment; (ii) our ability to address skin breakdown and pain at the stump site by promoting the skin properties found on the palms and soles; and (iii) our ability to re-program non-palmar/plantar skin to develop a thickened stratum corneum and express keratin-9. 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 Fibrocell Science's control. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) uncertainties relating to the initiation and completion of pre-clinical and clinical trials; (ii) uncertainties relating to regulatory approval; and (iii) our ability to maintain our collaboration with Lt. Col. Jon Meyerle, MD, of the Uniformed Services University of the Health Sciences, as well as those set forth under the caption "Item 1A. Risk Factors" in Fibrocell Science's most recent Form 10-K filing, as updated in "Item 1A. Risk Factors" in Fibrocell Science's most recent Form 10-Q filing. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. In addition, Fibrocell Science operates in a highly competitive and rapidly changing environment, and new risks may arise. Accordingly, you should not place any reliance on forward-looking statements as a prediction of actual results. Fibrocell Science disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statement. You are also urged to carefully review and consider the various disclosures in Fibrocell Science's most recent annual report on Form 10-K, our most recent Form 10-Q as well as other public filings with the SEC since the filing of Fibrocell Science's most recent annual report.