See this page online at: http://www.laboratoryfocus.com/ClinicalTrialsandPatents4
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Five to choose from.
Isotechnika Inc. (Edmonton, AB) has received a Notice of Allowance in the U.S. for its lead compound ISA247, a novel immunosuppressive drug currently under investigation for the prevention of organ rejection in kidney transplant patients, and for the treatment of psoriasis.
Winnipeg, Man.-based Medicure Inc. has received a U.S. patent covering composition of matter and compound claims in a series of novel drugs for the treatment of cardiovascular and related diseases. This is the company’s ninth patent. Medicure focuses on the development of therapeutics for unmet needs in cardiovascular medicine.
H3 Pharma Inc. (Montreal, QC) has submitted a New Drug Application for Sanvar® IR to the U.S. Food and Drug Administration. Sanvar is a somatostatin analogue used in the treatment of esophageal variceal bleeding, designed to stop hemorrhage prior to endoscopic intervention and to prevent recurring bleeding in the days following treatment.
Positive early trial results have been noted for Oncolytics Biotech Inc.’s (Calgary, AB) prostate cancer drug Reolysin®. The initial six-person trial demonstrated that Reolysin was effective in selectively infecting and killing tumour cells. The company has also received approval in the U.K. to conduct a Phase I clinical trial of Reolysin in the treatment of advanced or metastatic solid tumours. The trial’s primary objectives are to determine maximum tolerated dose, dose-limiting toxicity and Reolysin’s safety profile.
Delex Therapeutics Inc. (Mississauga, ON) has commenced dosing in its Phase II clinical trial of AeroLEF™ in post-surgical patients. The study, being conducted at the Toronto General Hospital (Toronto, ON) and the Queen Elizabeth II Hospital (Halifax, NS), is designed to confirm AeroLEF’s analgesic effects in adult patients experiencing moderate to severe pain following elective knee surgery.
Results from two clinical trials of Stressgen Biotechnologies Corp.’s (Victoria, BC) lead compound HspE7 have been released. The Phase II clinical trial for recurrent respiratory papillomatosis (RRP) showed high statistical significance in lengthening the interval between surgeries, achieving the trial’s primary end point. The company plans to move forward with a pivotal trial, and will submit a Biologics License Application for RRP as the first indication for HspE7. The second trial — which investigated HspE7 for anal dysplasia — met its secondary end points of physician’s global assessment for anal dysplasia and a subset of patients with concomitant genital warts, but did not achieve its primary end point of measuring adjudicated pathological assessment of biopsies.