Primary Endpoint Results Expected in Second Quarter of 2016
Personalized Biologics Pipeline Advancing in Skin and Connective Tissue
EXTON, Pa., April 21, 2016 (GLOBE NEWSWIRE) — Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing transformational therapies for diseases affecting the skin, connective tissue and joints, today announced that the last patient visit for primary endpoint analysis has been completed in its Phase II clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia. Fibrocell’s azficel-T has the potential to address the underlying cause of chronic dysphonia by using the patient’s own cells for localized treatment of the scarred vocal cords to improve voice quality.
“Achieving this milestone in our Phase II trial is significant in the development of azficel-T for the treatment of vocal cord scarring resulting in chronic dysphonia,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “This accomplishment acknowledges the progress in our pipeline of personalized biologics and our hope to deliver a treatment that could restore the voices of patients whose ability to speak has been compromised or lost.”
Vocal cord scarring is caused by damage to the fibroblast layer of the vocal cords which reduces vocal cord elasticity and airflow, affecting voice tone and volume. This reduction in vocal capacity is referred to as dysphonia, severe cases of which can lead to a total loss of voice. Current treatments for vocal cord scarring, which include voice therapy and surgery through the use of injection (collagen, fat, calcium, hyaluronic acid) or implant (PTFE, silastic), only address the symptoms of vocal cord scarring and have inconsistent efficacy. Fibrocell’s azficel-T has the potential to address the underlying cause of vocal cord scarring by restoring the extracellular matrix to repair damage to the fibroblast layer of the vocal cords, resulting in improved voice quality.
Fibrocell’s Phase II study is a double-blind, randomized, placebo-controlled trial designed to test the safety and efficacy of azficel-T injections in subjects with chronic dysphonia caused by idiopathic vocal fold scarring or atrophy. Primary efficacy is being assessed at four months post last treatment on three different scales: Voice Handicap Index, Mucosal Wave Grade and GRBAS, or grade, roughness, breathiness, asthenia and strain. Fibrocell expects to report primary endpoint results for this Phase II trial in the second quarter of 2016.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs. Fibrocell’s most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast technology and is in a Phase II clinical trial for the treatment of vocal cord scarring resulting in chronic or severe dysphonia. In collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology, Fibrocell is also developing gene therapies for diseases affecting the skin, connective tissue and joints using genetically-modified autologous fibroblasts. Fibrocell recently received allowance from the FDA to initiate a Phase I/II clinical trial of FCX-007 in adult subjects, and expects to initiate the Phase I portion of the trial in the second quarter of 2016. FCX-007 is Fibrocell’s lead gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its gene-therapy product candidate for the treatment of linear scleroderma. In addition, Fibrocell and Intrexon are in collaboration to develop a gene therapy for the treatment of arthritis. For more information, visit www.fibrocell.com or follow us on Twitter at @Fibrocell.
Fibrocell Trademarks
Fibrocell™ and Fibrocell Science® are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners.
Fibrocell 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. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the initiation, design and timing of our clinical trials, and the reporting of results thereof; the potential advantages of our product candidates; and other statements regarding our future operations, financial performance and financial position, prospects, strategies, objectives and other future events.
Forward-looking statements are based upon management’s current expectations, intentions and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially and adversely from those indicated herein including, among others: our ability to obtain additional capital to fund our operations; FDA allowance to treat pediatric subjects in the Phase II portion of our Phase I/II clinical trial of FCX-007; uncertainties relating to the initiation and completion of clinical trials; whether clinical trial results will validate and support the safety and efficacy of our product candidates; varying interpretation of clinical and non-clinical data; our ability to maintain our collaboration with Intrexon Corporation; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in our most recent Form 10-K filings. As a result, you are cautioned not to place undue reliance on any forward-looking statements. While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, whether as a result of new information, future developments or otherwise.
CONTACT: Investor Relations Contact: John Woolford Westwicke Partners 443.213.0506 john.woolford@westwicke.com Media Relations Contact: Michael Parks 484.356.7105 michael@pitch360inc.com
