Fibrocell Science, Inc. Announces Positive Results of Its Pilot Study for Treatment of Vocal Fold Scarring With Fibroblasts
EXTON, Pa.--(BUSINESS WIRE)--Feb 16, 2011 - Fibrocell Science, Inc. (OTCBB:FCSC), a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today publication of results of a five-patient pilot study evaluating the safety and effectiveness of autologous fibroblasts to treat vocal fold scarring in The Laryngoscope, a peer reviewed scientific journal. The study was conducted by Dinesh K. Chhetri, MD, Associate Professor, Division of Head and Neck Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California.
The Chhetri study showed that autologous fibroblasts cultured and expanded in Fibrocell's cGMP facility and injected into the lamina propria (LP) layer of the vocal folds as an outpatient procedure appeared to be well-tolerated and to produce both objective and subjective improvements in voice quality that were sustained up to 12 months after treatment. Sustained trends for improvement are supported by data for mucosal wave grade assessment, voice handicap index (VHI), and voice quality questionnaire. Subjects with vocal fold scarring limited to the LP appeared to have the best response to treatment. Two subjects experienced temporary otalgia (ear pain) during the treatment process, but this adverse event resolved rapidly once the injection process stopped, and neither patient dropped out of the study due to the events. No other adverse events related to the treatment were reported during the study.
“We are very pleased with the results of the pilot study, which demonstrates that our autologous fibroblasts therapy offers real hope for patients with vocal scars as it helps improve voice by reestablishing normal mucosal pliability of the vocal folds,” said David Pernock, Fibrocell Science Chairman and CEO. “We're extremely grateful to our colleagues at the UCLA for their efforts in making this pilot study possible.”
Dr. Chhetri commented, “To date no durable biocompatible material exists that matches the native viscoelastic properties of the LP layer. Cellular-based approaches using tissue engineering and regenerative medicine techniques like Fibrocell's autologous fibroblasts are promising for the treatment of vocal scars because patients' own cells are made to work to re-create the extracellular matrix of the LP layer, potentially reestablishing normal mucosal pliability of the vocal folds.”
During this prospective, open-label, single arm, pilot study, autologous fibroblasts were expanded in cell culture from punch biopsies of the buccal mucosa of five human subjects with vocal fold scarring. Three doses of 1–2 x 107 cells/mL were injected into the superficial LP layer of each scarred vocal fold at four-week intervals. The primary efficacy measure was an objective evaluation of the mucosal wave grade; secondary measures included acoustic analyses, a patient-completed VHI survey, and voice quality questionnaire. Safety assessments included clinical laboratory blood tests, vital signs, and monitoring for adverse events. Patients were followed for 12 months following the first treatment.
About The Fibrocell Science Technology
Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.
Fibrocell Science's lead therapy, azficel-T, is an investigational autologous (personalized) 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. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on the development of autologous (personalized) 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. For additional information, please visit www.fibrocellscience.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. Forward-looking statements include, without limitation, the future approval of azficel-T and the Company ability to conduct studies on applying its autologous fibroblast technology in additional areas, including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease. 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, 2009, 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.
Contact: Fibrocell Science, Inc.
David M. Pernock
President & CEO
Phone: (484) 713-6000
Posted: February 2011