Trials & Patents

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Innodia Inc. (Montreal, QC) has begun a Phase I clinical trial in Canada of its oral drug ID 1101, which features a dual antidiabetic action. ID 1101 increases pancreatic secretion of insulin, while simultaneously decreasing the peripheral insulin resistance seen in Type 2 diabetes. In addition, the drug’s activities depend on abnormally high blood glucose concentrations, reducing the risk of hypoglycemia that can be associated with other antidiabetic agents. ID 1101 has been shown to be effective in several animal models with no evidence of toxicity. The Phase I trial involves 32 healthy volunteers and will establish the drug’s safety and pharmacokinetic profiles.
Liponex Inc. (Ottawa, ON) has been granted a U.S. patent for its first product, CRD5, which adjusts cholesterol levels to treat atherosclerosis. The company also announced the results of Phase I clinical trials of CRD5, which were carried out on 56 volunteers over a two-week period. Those findings indicate that the drug is safe and well tolerated, increasing HDL (“good”) cholesterol levels by an average of 18%, while lowering LDL (“bad”) cholesterol and triglyceride levels by as much as 15 and 60%, respectively. Phase II trials of CRD5, designed to show efficacy in patients with abnormal cholesterol levels, are expected to begin in 2005.
Vasogen Inc. (Mississauga, ON) presented preclinical research on its compound VP025, which revealed an ability to provide a significant neuroprotective effect in a well-established model of Parkinson’s disease. The model mimics this condition by introducing 6-hydroxydopamine (6-OHDA), which creates inflammatory processes that lead to the death of dopaminergic nerve cells in the brain and subsequent abnormalities in movement. During a three-week study that employed VP025 before 6-OHDA was administered, these abnormalities were significantly reduced, as was the loss of dopaminergic neurons. VP025, which interacts with immune cells and modulates cytokines that control inflammation, is being developed by Vasogen as the company’s lead product in a new class of agents for treating chronic neuro-inflammatory disorders.
The U.S. Food and Drug Administration has granted EquiTech Corp. (Edmonton, AB) clearance to begin a human trial of ZAG-1701, an ibuprofen caplet reformulated by the company. The 12-week Phase II clinical trial will measure bloodstream absorption of ibuprofen in patients who have undergone wisdom tooth extraction, comparing the absorption rate of the EquiTech caplet with that of another ibuprofen product.