LAVAL, Quebec, March 19, 2013 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti") (TSX-V:APO) (Nasdaq:ACST), a Neptune Technologies & Bioressources Inc. ("Neptune") subsidiary, announces encouraging preliminary clinical data of its "Randomized, Open-Label, Dose-Ranging, Multi-Center Trial to assess the Safety and efficacy of NKPL66 (CaPre®) in the treatment of mild-to-high hypertriglyceridemia" (Open-label). In the course of planning the strategy of its phase III clinical development with CaPre®, Acasti examined triglycerides data from its Open-label clinical trial.
Data from 157 patients who have completed four weeks of treatment with 0.5, 1, 2 or 4 grams of CaPre® per day were assessed and CaPre® achieved a clinically important and statistically significant triglyceride reduction of up to 23% (p < 0.05) as compared to standard of care, after only a 4-week treatment. Moreover, a noteworthy trend indicating a dose-response relationship versus standard of care as well as clinically and statistically significant effects of doubling the doses of CaPre® were observed.
It should also be noted that the study assesses the effectiveness of CaPre® in a real-life, routine - clinical setting since the standard of care may be any treatment the treating physicians considered as appropriate and included life-style modification as well as lipid modifying agents such as statins and fibrates, that most of the patients analysed (i.e. 86%) had baseline triglycerides between 200 and 500mg/dl (2.28 to 5.7 mmol/L) and that no serious adverse events were reported.
To date, the results of this preliminary analysis suggest that CaPre® is safe and effective for the treatment of patients with triglyceride levels ranging from 200 to 500 mg/dL. "We're pleased with the triglycerides responses in this difficult to treat population. We're looking forward to the near term completion of the study and the complete evaluation of our drug on the entire lipid profile of this patient population," stated Dr. Harlan Waksal, Executive Vice-President.
This information confirms previously reported data from a cohort of patients that completed an eight-week treatment with 2g CaPre® per day, showing a statistically significant 25% (p<0.05) reduction in triglycerides after eight weeks of treatment.
Acasti Pharma is developing a product portfolio of proprietary novel long-chain omega-3 phospholipids. Phospholipids are the major component of cell membranes and are essential for all vital cell processes. They are one of the principal constituents of High Density Lipoprotein (good cholesterol) and, as such, play an important role in modulating cholesterol efflux. Acasti Pharma's proprietary novel phospholipids carry and functionalize the polyunsaturated omega-3 fatty acids EPA and DHA, which have been shown to have substantial health benefits and which are stabilized by potent antioxidants. Acasti Pharma is focusing initially on treatments for chronic cardiovascular and cardiometabolic conditions within the over-the-counter, medical food and prescription drug markets.
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