Mon, Apr. 25, 9:15 AM
- Thinly traded micro cap Fibrocell Science (NASDAQ:FCSC) is up 7% premarket on light volume in response to its announcement that the FDA has designated gene therapy FCX-013 an Orphan Drug for the treatment of localized scleroderma, a chronic autoimmune disorder characterized by the painful and debilitating thickening of the skin and connective tissue.
- FCX-013, an autologous fibroblast cell designed to break down excess collagen at the site of disease, utilizes Intrexon's (NYSE:XON) gene regulation technology called RheoSwitch which offers transcriptional control of a range of therapeutic genes.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Wed, Apr. 20, 12:45 PM
Oct. 9, 2015, 11:51 AM
- Thinly traded micro cap Fibrocell Sciences (FCSC +16.3%) heads north, albeit on light volume, in apparent response to a poster presentation at the American Society of Human Genetics Annual Meeting in Baltimore, MD. The poster, titled "Pre-Clinical Development of a Genetically-Modified Human Dermal Fibroblast for the Treatment of Recessive Dystrophic Epidermolysis Bullosa" (RDEB) contained data from an in vivo pre-clinical study of FCX-007 in severe combined immunodeficiency mice (SCID).
- The study evaluated FCX-007 for toxicology and biological proof-of-concept in RDEB and normal human skin xenografts implanted in SCID mice. Toxicology results at week two and week six after administration showed no test article-related findings (no effects observed related to FCX-007), no tumors in the skin grafts or other organs, no statistical changes in blood chemistry and no apparent systemic distribution of the vector (genetically-modified fibroblast cells).
- Also, data supporting the proof-of-concept showed FCX-007 cells in a human xenograft model expressed COL7 (type VII collagen) that localized to the basement membrane zone where anchoring fibrils are formed. RDEB sufferers do not produce COL7, the main component of anchoring fibrils that connect skin layers. This causes their skin to blister and peel off in response to any kind of friction.
- FCX-007 is Fibrocell's gene therapy candidate for the treatment of RDEB. Its value proposition is the delivery of high levels of COL7 directly to affected areas. Current standard-of-care treatment, bandaging and antibiotics, just address the symptoms.
Sep. 25, 2015, 1:26 PM
- Thinly traded micro cap Fibrocell Sciences (FCSC -22.2%) is off on a 50% spike in volume, albeit on turnover of less than 500K shares, in response to its announcement that the FDA has requested a new toxicology study to support its IND application for the proposed Phase 1/2 study protocol for its gene therapy candidate FCX-007, under development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The new study should commence in Q4 and the data should be filed sometime in Q1, causing a delay in the start of the trial of six months or more.
- The toxicology study will assess the effects of an injection of FCX-007 in non-grafted SCID (severe combined immunodeficiency) mice. The toxicology study filed with the IND was based on the injection of FCX-007 in RDEB human skin that was xenografted onto SCID mice, which showed no toxicity.
- RDEB, caused by a deficiency in type VII collagen, is a rare inherited disorder characterized by blistering and missing areas of skin.
Sep. 25, 2015, 12:44 PM
Jul. 22, 2015, 12:45 PM
Jul. 22, 2015, 9:16 AM
May 14, 2015, 9:16 AM
May 13, 2015, 9:15 AM
May 13, 2015, 9:03 AM
- Thinly traded micro cap Fibrocell (NASDAQ:FCSC) is up 18% premarket on moderate volume in response to its announcement after the close yesterday that the FDA added the Rare Pediatric Disease designation to its Orphan Drug-tagged FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa. If FCX-007 is cleared for sale, the company will receive a voucher that it can use to obtain Priority Review for a future NDA or BLA. It can also sell or transfer the voucher, if desired.
- Previously: Fibrocell's FCX-007 gets Rare Pediatric Disease designation from FDA (May 12)
Mar. 25, 2015, 12:45 PM
Jan. 16, 2015, 12:45 PM
Jan. 14, 2015, 4:07 PM
- After resting for a couple of days, thinly-traded nano cap Fibrocell (NASDAQ:FCSC) breaks out on a healthy 10x surge in volume. On Monday, the company presented at the Biotech Showcase in San Francisco.
- The company develops therapies to treat rare and serious skin and connective tissue disease based on its proprietary Personalized Biologics platform. It is collaborating with Intrexon (NYSE:XON) to create genetically-modified fibroblasts that promote the expression of a desired protein(s) to treat the underlying cause of a disease.
- Its lead program is Azficel-T for the treatment of vocal cord scarring and restrictive burn scarring, currently in Phase 2 development.
Jan. 14, 2015, 12:43 PM
Jan. 9, 2015, 8:56 AM
- Thinly-traded nano cap Fibrocell Science (NASDAQ:FCSC) is up 65% premarket albeit on only 1,200 shares. No news is available that accounts for the move. Retail investors need to exercise caution here.
Dec. 31, 2014, 10:25 AM
- Thinly-traded nano cap Brainstorm Cell Therapeutics (BCLI +22.7%) jumps on a 6x surge in volume in response to CEO Tony Fiorino's positive comments about the final results from the Phase 2a study of NurOwn in ALS patients.
- Management will host a conference call on January 5 at 8:30 am ET to discuss the data.
- Previously: BrainStorm to start Phase 2 ALS trial (April 28)
- Stem cell-related tickers: (CUR +3.8%)(STEM)(NBS +0.5%)(OTCQB:ISCO +1.4%)(PSTI +2.2%)(OTCQB:NVIV -1.5%)(FCSC +1.6%)
Fibrocell Science, Inc. operates as a autologous cell therapy company, which focuses on developing treatments for skin and connective tissue diseases with unmet medical needs. The company has a pipeline of therapeutic and aesthetic product development programs based on the first Food and Drug... More
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