Acasti Pharma Presents Preliminary Data Moving Forward With Clinical Strategy
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
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.
About Acasti Pharma Inc.
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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Exchange Commission and the Canadian securities commissions.
CONTACT: Acasti Contact:
Chief Financial Officer
Howard Group Contact:
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