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XenoPort (Nasdaq: XNPT) $6.38. today announced along with GlaxoSmithKline (NYSE: GSK) that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. The efficacy of Horizant in the treatment of patients with moderate-to-severe primary Restless Legs Syndrome was demonstrated in two 12-week clinical trials in adults. It is the first medication in its class to be approved for the treatment of moderate-to-severe primary Restless Legs Syndrome.
“Clinical experience has substantiated that Restless Legs Syndrome, also referred to as Ekbom Disease, is a long-term neurological condition characterized by an urge to move caused by unpleasant sensations in the legs,” said Richard K. Bogan, M.D., FCCP, chairman and chief medical officer of SleepMed of South Carolina in Columbia, South Carolina, and a clinical trial investigator. “Our experience has shown that patients with moderate-to-severe primary Restless Legs Syndrome can suffer from a range of disruptive symptoms and may benefit from a new treatment option.”
What They Do: XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.
Array BioPharma (Nasdaq: ARRY) $3.21 Today announced that a $10 million clinical research milestone was achieved in its development collaboration with Novartis. Array entered into an agreement with Novartis in April 2010 for the worldwide development of the small-molecule MEK inhibitors MEK162 (ARRY-162), its back-up, ARRY-300, and other MEK inhibitors. The milestone was achieved after Novartis had its first patient visit in a Phase 2 clinical trial.
The Phase 2 trial is an open-label study to assess the safety and efficacy of MEK162 in patients with malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations. The trial is designed to measure the objective response rate to treatment with MEK162 when administered orally as 45 mg twice-daily to patients. The trial will also evaluate progression-free survival, safety and tolerability.
What They Do: Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, inflammatory and metabolic diseases.
Spectranetics Corporation (Nasdaq: SPNC) $4.92. Today announced that it plans to initiate the EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) clinical trial following the recent conditional approval of the Company’s investigational device exemption (IDE) application by the Food and Drug Administration (FDA). The study will compare the safety and efficacy of excimer laser atherectomy utilizing the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, with that of balloon angioplasty alone in a 2:1 fashion on patients with femoropopliteal in-stent restenosis (ISR), a condition caused by the development of scar tissue within a previously implanted stent.
EXCITE ISR will enroll up to 353 patients at up to 30 sites in the U.S., with first patient enrollment expected within 30 days. The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularization (TLR) through 30 days following the procedure. The trial’s primary efficacy endpoint is freedom from clinically-driven TLR (re-intervention), which will be evaluated at six months following the procedure. These results will be included in a 510k filing with the FDA. The study will employ three separate independent core laboratories and an independent Data Safety and Monitoring Board.
What They Do: Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system.
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