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Clinical Trials & Patents

The Therapeutic Products Directorate of Health Canada has given GB Therapeutics Ltd. (Mississauga, ON) approval to proceed with its Phase Ia clinical study of GT 1061 in healthy, aged volunteers. GT 1061 is a molecule targeted at mild to moderate Alzheimer’s disease that aims to improve memory and slow disease progression.


Toronto, Ont.-based Transition Therapeutics Inc. has received approval to extend the Phase I human clinical trial of its Islet Neogenesis Therapy (INT™), in which patients are given escalating doses of individual INT growth factors, gastrin analogue or epidermal growth factor analogue. The trial began last month, and is expected to be complete in February.


Axcan Pharma Inc. (Mont St-Hilaire, QC) has submitted a supplemental New Drug Application to the Therapeutic Products Directorate for a 750-mg tablet form of Salofalk for the treatment of ulcerative colitis. Axcan currently has 250-mg and 500-mg tablets of Salofalk on the market in Canada for Crohn’s disease and ulcerative colitis.


Product-development company MBEC BioProducts Inc. (Edmonton, AB) has received three additional U.S. patents for its MBEC™ Assay, used in biofilm research and antibiotic and biocide development. The three new patents provide MBEC with intellectual property protection to test specialized coatings for anti-biofilm activity.


Lorus Therapeutics Inc. (Toronto, ON) has published positive, preclinical investigational results of studies that were designed to characterize NC 381, a clotrimazole (CLT) analogue. CLT is an anti-fungal drug that has shown anticancer activity, but also high liver toxicity. The study aimed to develop a CLT variation that maintained its anticancer mechanism without the harmful side-effects.


Procyon Biopharma Inc. (Dorval, QC) has received a U.S. patent covering a novel family of compounds that inhibit HIV protease activity. The new patent is Procyon’s eighth U.S. patent covering HIV protease inhibitors. Procyon works to discover and develop therapeutics and diagnostics in the areas of oncology and infectious diseases.


International Wex Technologies Inc. (Vancouver, BC) and the Chinese State Food and Drug Administration met recently to discuss the Phase II study of Tectin™ in non-malignant, chronic pain. Positive interim results from the Phase IIa Canadian study — in which Tectin relieved chronic pain in 68% of cancer pain patients — were also discussed. International Wex develops and commercializes drug products, focusing on pain management.

February 2006
Nuvo Research Inc.
Markham, Ont.-based Nuvo Research Inc. has released preliminary efficacy results from its Phase III clinical trial for Pennsaid®, the company's topical non-steroidal anti-inflammatory for treatment of osteoarthritis.

February 2006
Tibotec Inc.
Health Canada has approved a compassionate-use clinical trial protocol allowing Vancouver-area AIDS patients to receive two experimental drugs

February 2006
Dorval, Que.-based Procyon Biopharma Inc
Has received approval from Health Canada's Therapeutic Products Directorate for a first-in-man Phase I clinical trial for PPL-100, its lead protease inhibitor for treatment of drug-resistant HIV.

February 2006
Angiotech Pharmaceuticals Inc.
Has initiated a U.S. pivotal study to evaluate the efficacy of a central venous catheter (CVC) coated with the company's non-traditional, anti-infective drug, 5-Flourouracil (5-FU).