Wired News – Fibrocell Science Gets FDA Allowance to Start Pediatric Enrollment in Phase-1/2 Clinical Trial of FCX-007 for the Treatment of RDEB
LONDON, UK / ACCESSWIRE / February 01, 2018 / Active-Investors.com has just released a free research report on Fibrocell Science, Inc. (NASDAQ: FCSC) (“Fibrocell”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=FCSC as the Company's latest news hit the wire. On January 30, 2018, Fibrocell, an autologous cell and gene therapy Company that focuses on transformational cell-based therapies for skin and connective tissue, announced that it has received allowance from the US Food and Drug Administration (FDA) to commence the enrollment of pediatric patients for the Phase-2 portion of the Phase-1/2 clinical trial of FCX-007. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Fibrocell Science most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Recessive Dystrophic Epidermolysis Bullosa (RDEB), a Devastating Skin Disease
Dystrophic epidermolysis bullosa (DEB) is a group of rare inherited diseases that cause skin fragility and blistering. RDEB is the most devastating, and severe type of DEB. It is caused by the deficiency of the protein type VII collagen (COL7). RDEB is characterized by widespread blistering that can lead to vision loss, disfigurement, and other serious medical problems. When these blisters heal, it leads to severe scarring. Scarring in the mouth and esophagus makes it difficult to eat food, leading to poor nutrition as well as slow growth. Moreover, individuals suffering from this condition are at a high risk of developing squamous cell carcinoma, which is an unusually aggressive and life-threatening cancer.
FCX-007 For Treatment of RDEB
FCX-007 is Fibrocell's clinical-stage gene therapy candidate that is being developed in collaboration with Intrexon Corporation (NYSE:XON) for the treatment of RDEB. FCX-007 is a genetically modified autologous fibroblast, which encodes the gene for COL7. FCX-007 treats the underlying cause of the disease by genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection. It, thus, provides high levels of COL7 directly to the affected areas while avoiding systemic distribution. FDA has granted the Orphan Drug, Rare Pediatric Disease and Fast Track Designations to FCX-007. At present, it is the subject of the Phase-1/2 clinical trial for the treatment of RDEB.
About the Phase-1/2 Clinical Trial
Phase-1/2 Clinical Trail is an open-label clinical trial intended to assess the safety of FCX-007 in RDEB patients. Besides, it also intends to evaluate wound healing and pharmacology at 4, 12, 25, and 52 weeks post-administration. In the Phase-2 portion of the trial, six patients aged seven and older are targeted to be treated with FCX-007.
In fact, one RDEB adult patient has already been enrolled in Phase-2, but the dosing is expected to occur in the second quarter of 2018.
FDA Allowance Driven by Positive Data from Phase-1 Portion of the Phase-1/2 Clinical Trial
The FDA allowance is based on the evidence of safety and potential benefit of FCX-007 in adult patients dosed in the Phase-1 portion of the clinical trial. In its submission, Fibrocell had shared the interim readout of safety data from three adult patients 12 weeks post-administration and one adult patient 25 weeks post-administration. The data demonstrated that FCX-007 was well tolerated after a single intradermal injection session in targeted wounds and separate intact skin sites. There were no serious adverse events and no product-related adverse events. Besides, positive early trends were also observed in wound healing and pharmacology signals to substantiate the potential benefit of the product candidate.
One Step Closer to Fibrocell's Goal
John Maslowski, the President and Chief Executive Officer at Fibrocell, believes that this FDA allowance to include pediatric patients in the Phase-2 portion of the FCX-007 clinical trial implies significant clinical progress for Fibrocell. It takes the Company one step closer to its goal of transforming the lives of RDEB patients. Fibrocell's unique approach to treatment, i.e. targeting the underlying origin of the disease, makes it possible to relieve the chronic symptoms and suffering related to RDEB.
Alfred Lane, MD, Chief Medical Advisor of Fibrocell and Professor of Dermatology and Pediatrics (Emeritus) at the Stanford University School of Medicine shared that pediatric RDEB patients are the worst affected by this debilitating disease as the scarring that develops in childhood progresses into adulthood. Thus, he is pleased that the Company would now be allowed to evaluate FCX-007 in children and thus improve wound outcomes for these patients.
Stock Performance Snapshot
January 31, 2018 - At Wednesday's closing bell, Fibrocell Science's stock slightly fell 0.30%, ending the trading session at $0.66.
Volume traded for the day: 326.34 thousand shares.
Stock performance in the last month – up 3.44%; and year-to-date - up 3.44%
After yesterday's close, Fibrocell Science's market cap was at $14.47 million.
The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry.
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