Stock Monitor: OptiNose Post Earnings Reporting
LONDON, UK / ACCESSWIRE / May 23, 2018 / If you want access to our free research report on Fibrocell Science, Inc. (NASDAQ: FCSC), 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 May 21, 2018, the Company presented an update on the interim results and progress of its Phase-1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) at the 7th International Investigative Dermatology (IID) meeting held on May 19, 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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FCX-007 was Well-Tolerated up to 52 Weeks Post-Administration
The primary objective of open-label, Phase-1/2 clinical trial is to evaluate the safety of FCX-007 in RDEB patients. Additionally, the trial is assessing wound healing and pharmacology at 4, 12, 25 and 52 weeks post-administration. Four adult patients aged 20 to 37 have been dosed with FCX-007 in the margins of and across targeted wounds, as well as in separate intact skin sites. Three patients received a single intradermal injection session at baseline. One patient received a second injection session in the remaining unhealed areas of wounds at 25 weeks post-administration, as allowed by the clinical trial protocol.
Safety data from these patients show FCX-007 was well-tolerated up to 52 weeks post-administration. There were no serious adverse events and no product related adverse events reported. No type VII collagen (COL7) autoantibody response was noted. Various COL7 expression signals were detected throughout the data set using either immunofluorescence (IF) or immunoelectron microscopy (IEM) up to 52 weeks post-administration. Continued positive trends were noted in wound healing and pharmacology signals, including type VII collagen expression and evidence of anchoring fibrils.
Enrollment of Six Patients in Phase-2 Portion of the Trial is Expected to be Completed in Q3 2018
John Maslowski, President and CEO of Fibrocell, said that the Company is pleased with the continued progress of its FCX-007 program that offers promise to be transformative for RDEB patients.
John added that based on safety, pharmacology, and wound healing data, Fibrocell plans to continue exploring dose range and administration for future patients.
The Company reported that one patient has been enrolled in the Phase-2 portion of the trial, with three additional screening visits scheduled prior to the end of June 2018. Enrollment of six patients is expected to be completed in Q3 2018.
About Recessive Dystrophic Epidermolysis bullosa
RDEB is a congenital, progressive, devastatingly painful, and debilitating genetic disorder that often leads to death, and is the most severe form of dystrophic epidermolysis bullosa. RDEB causes severe blistering and areas of missing skin, which is a response to any kind of friction, including normal daily occurrences like rubbing or scratching. Children who inherit the condition are often called "butterfly children" because their skin is as fragile as a butterfly's wings. RDEB patients do not produce functional COL7 due to a mutation in the COL7A1 gene. Collagen 7, a protein, is the main component of anchoring fibrils that hold together the layers of skin. Without these fibrils, skin layers separate causing severe blistering, open wounds and scarring in response to any kind of friction or trauma.
FCX-007 is Fibrocell's clinical-stage, gene therapy product candidate for the treatment of RDEB. FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7 and is being developed in collaboration with Precigen, Inc., a wholly owned subsidiary of Intrexon Corporation. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution.
About Fibrocell Science, Inc.
Founded in 1992 and headquartered in Exton, Pennsylvania, Fibrocell Science is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue.
Stock Performance Snapshot
May 22, 2018 - At Tuesday's closing bell, Fibrocell Science's stock fell 7.34%, ending the trading session at $0.70.
Volume traded for the day: 1.49 million shares, which was above the 3-month average volume of 591.22 thousand shares.
Stock performance in the last month – up 19.36%; previous three-month period – up 7.09%; and year-to-date - up 10.03%
After yesterday's close, Fibrocell Science's market cap was at $23.94 million.
The stock is part of the Healthcare sector, categorized under the Drugs - Generic industry.
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