Patient Dosing in Phase II Trial of azficel-T for Chronic Dysphonia Completed Preclinical Toxicology Study for FCX-007 Initiated Positive POC Data Shows FCX-013 Reduces Dermal Thickness of Fibrotic Tissue
EXTON, Pa., Jan. 27, 2016 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc., (NASDAQ: FCSC ), an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs, today highlighted several recent accomplishments related to the continued advancement of the company’s pipeline.
“Recently, Fibrocell has made significant progress across our pipeline of personalized biologics, positioning the company to achieve value-creating milestones in 2016,” said David Pernock, Chairman and Chief Executive Officer. “We are encouraged by this progress that brings us closer to delivering potentially transformative therapies for patients suffering from debilitating diseases of the skin and connective tissue.”
Fibrocell completed patient dosing in its Phase II clinical trial of azficel-T for the treatment of vocal fold scarring resulting in chronic or severe dysphonia. The ongoing study is a double-blind, randomized, placebo-controlled trial designed to test the safety and efficacy of azficel-T in subjects with chronic dysphonia caused by idiopathic vocal fold scarring or atrophy. As efficacy endpoints will be assessed four months after final treatment, Fibrocell continues to expect to report these primary endpoint results in the second quarter of 2016.
Fibrocell has also initiated the toxicology study previously requested by the U.S. Food and Drug Administration (FDA) related to the company’s Investigational New Drug (IND) application for FCX-007, its gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa. In this study, FCX-007 was injected in non-grafted SCID (severe combined immunodeficiency) mice. Fibrocell expects to amend its IND to include data from this toxicology study in the first quarter of 2016 and, subject to FDA approval, initiate a Phase I/II clinical trial in the second quarter of 2016.
Furthermore, Fibrocell completed a proof-of-concept study for FCX-013—the company’s gene-therapy product candidate for the treatment of linear scleroderma—to determine its potential to reduce dermal thickness in fibrotic tissue. FCX-013 was evaluated in a bleomycin-induced scleroderma model, utilizing SCID mice. Data from the study demonstrated that FCX-013 reduced the dermal thickness of fibrotic tissue to levels similar to non-bleomycin (saline) treated skin and further reduced the thickness of the sub-dermal muscle layer. Fibrocell will now advance FCX-013 into preclinical dose ranging studies for product optimization and now expects to submit an IND application to the FDA in 2017.
Both FCX-007 and FCX-013 are being developed in collaboration with Intrexon Corporation (NYSE: XON ), a leader in synthetic biology.
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 fold 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 skin and joint diseases using genetically-modified autologous fibroblasts. Fibrocell is in preclinical development of FCX-007, its orphan gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is also in preclinical development of FCX-013, its gene-therapy product candidate for the treatment of linear scleroderma. In addition, Fibrocell and Intrexon will be commencing preclinical development of a gene-therapy for the treatment of chronic inflammatory and degenerative diseases of the joint, including arthritis and related conditions. For more information, visit www.fibrocell.com .
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 statements relating to: the potential achievement of value-creating milestones in 2016; the expected reporting of results from our Phase II clinical trial of azficel-T in the second quarter of 2016; the expected amendment to our IND for FCX-007 in the first quarter of 2016 and the expected initiation of a Phase I/II clinical trial for FCX-007 in the second quarter of 2016; the expected submission of an IND for FCX-013 in 2017; the potential for our collaboration with Intrexon to yield products to address chronic inflammatory and degenerative diseases of the joint; and other statements regarding our future operations, financial performance, 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 expressed or implied by such statements including, among others: our ability to successfully complete the additional toxicology study requested by the FDA and to adequately address the FDA’s other feedback relating to our IND for FCX-007; the outcome of the FDA’s review of our IND for FCX-007 and approval to commence the proposed Phase I/II trial; risks inherent in drug discovery and development; uncertainties relating to the initiation and completion of clinical trials; varying interpretation of preclinical data; the risk that results seen in preclinical studies may not be replicated in humans; our ability to maintain our collaborations with Intrexon; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in our most recent Form 10-K and Form 10-Q filings, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the Securities and Exchange Commission. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Additionally, the forward-looking statements contained in this press release represent our views only as of the date of this release. 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: Karen Casey Fibrocell 484.713.6133 kcasey@fibrocell.com
