Acasti Pharma Announces the Initiation of Phase II Clinical Study of CaPre(R) for the Treatment of Hypertriglyceridemia
October 04 2011 - 9:08AM
Acasti Pharma Inc. (Acasti) (TSX.V:APO), a subsidiary of Neptune
Technologies & Bioressources Inc. (Neptune), announces the
initiation of the clinical stage of its development by enrolling
the first patients in its phase II clinical
trial to assess the safety and efficacy of its
prescription drug candidate, CaPre®, for patients with
hypertriglyceridemia. This corporate milestone aligns with
Acasti's goal of creating higher value for its shareholders, by
allowing the Company to advance into the clinical stage of its drug
development program, having successfully completed the preclinical
stage, and having obtained Canadian regulatory and ethical
committee approvals.
"CaPre® is a novel compound that has repeatedly demonstrated
preclinical significant lipid management activity superior to
existing treatment options for high triglycerides. Preclinical
results have shown that CaPre®, at a low human equivalent dose of
0.5 to 2g per day, is safe and effective in managing
cardiometabolic disorders by reducing triglycerides by 60% while
significantly increasing HDL, reducing LDL and controlling glucose
intolerance in the animal models," stated Dr. Tina Sampalis,
President. "Once approved, CaPre® could be targeting 93% of more
than 40 million Americans with moderately high
to very high triglycerides compared to only 7%
targeted by the leading prescription omega-3 drug in the USA,
making it an attractive future opportunity for pharmaceutical
alliances," she added.
"We are very pleased to enroll the first patients to
be treated with CaPre®. The CaPre® clinical
study will give us a first look at the potential
benefits of CaPre® in this large patient
population of individuals with hypertriglyceridemia. We
believe CaPre® will further benefit this dyslipidemic
population with a concurrent LDL (bad cholesterol)
reduction and HDL (good cholesterol) increase, in comparison to
existing options that reduce triglycerides with minimal affect on
HDL and increasing LDL, making CaPre® a potential
best-in-class," stated Dr. Harlan Waksal, Executive
Vice-President. "The AHA 2006 to 2010 statistical
fact sheets updates reported that more than 145 million
Americans have been diagnosed with cardiometabolic disorders
and, according to the 2009 Heart Disease and Stroke Statistics
Update, the estimated direct and indirect costs
of cardiovascular disease and stroke in the United States
totaled USD 475 billion, of which USD 52 billion was spent
only on medications representing a great market opportunity for
CaPre®," he added.
The Principal Investigator of the trial, Dr.
Jacques Genest, stated, "This study was designed with input
from world renowned experts in the field and
reviewed by Health Canada. Elevated triglycerides are an
independent risk factor; it is important to understand the clinical
utility of phospholipid omega-3 fatty acids and how they
might differentiate from existing treatment options. This
study of CaPre® will contribute significantly to our knowledge
of this new drug class."
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 conditions within the
over-the-counter, medical food and prescription drug markets.
About Neptune Technologies & Bioressources
Inc.
Neptune is an industry-recognized leader in the innovation,
production and formulation of science-based and clinically proven
novel phospholipid products for the nutraceutical and
pharmaceutical markets. The Company focuses on growing consumer
health markets including cardiovascular, inflammatory and
neurological diseases driven by consumers taking a more proactive
approach to managing health and preventing disease. The Company
sponsors clinical trials aimed to demonstrate its product health
benefits and to obtain regulatory approval for label health claims.
Neptune is continuously expanding its intellectual property
portfolio as well as clinical studies and regulatory approvals.
Neptune's products are marketed and distributed in over 20
countries worldwide. Neptune is the mother company of Acasti and
NeuroBioPharm.
"Neither Nasdaq nor the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release." Statements in this press release that
are not statements of historical or current fact constitute
"forward-looking statements" within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995 and Canadian
securities laws. Such forward-looking statements involve known and
unknown risks, uncertainties, and other unknown factors that could
cause the actual results of the Company to be materially different
from historical results or from any future results expressed or
implied by such forward-looking statements. In addition to
statements which explicitly describe such risks and uncertainties,
readers are urged to consider statements labeled with the
terms "believes," "belief," "expects," "intends," "anticipates,"
"will," or "plans" to be uncertain and forward-looking. The
forward-looking statements contained herein are also subject
generally to other risks and uncertainties that are described from
time to time in the Company's reports filed with the Securities and
Exchange Commission and the Canadian securities commissions.
CONTACT: Acasti Contact:
Tina Sampalis
President
+1 450.686.4555
t.sampalis@acastipharma.com
www.acastipharma.com
Xavier Harland
Chief Financial Officer
+1.450.687.2262
x.harland@acastipharma.com
www.acastipharma.com
Howard Group Contact:
Dave Burwel
+1 888.221.0915
dave@howardgroupinc.com
www.howardgroupinc.com
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