Acasti Pharma Inc. Receives Health Canada Clearance for Phase II Hypertriglyceridemia Trial and Awards for Innovation
30 June 2011 - 10:00PM
Acasti Pharma Inc. (Acasti) (TSX-V:APO), a subsidiary of Neptune
Technologies & Bioressources Inc. (Neptune), has received a
positive response from Health Canada regarding its previously
announced Clinical Trial Application (CTA), thereby allowing the
initiation of a phase II clinical trial with CaPre®.
Health Canada informed Acasti that there was no objection to
Acasti's proposed study based on the information and material
provided to support the CTA. Therefore, Acasti will initiate a
phase II human clinical trial to investigate the use of CaPre® as a
treatment for patients with dyslipidemia. Enrollment in the study
is expected to commence in the next few weeks with results
anticipated in 2012. The design of the study is a randomized,
double blind, placebo controlled trial to assess the safety and
efficacy of CaPre® in patients with triglyceride levels ranging
from moderately high to very high, which distinguishes CaPre® from
prescription drug fish oils labelled only to treat patients with
very high levels of triglycerides.
"According to the American Heart Association (AHA), 16.2% of the
U.S. population (more than 40 million Americans) has moderately
high to very high triglyceride levels while only 1.1%
(approximately 3 million Americans) has very high triglyceride
levels. Moreover, the AHA 2006 to 2010 statistical fact
sheets updates reported that more than 145 million Americans have
been diagnosed with cardiometabolic disorders. 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 totalled USD $475 billion, of which USD $52
billion was spent on medications," indicated Pierre Lemieux, Chief
Operating Officer. "We are pleased with Health Canada's
authorization, as it represents another hurdle cleared in Acasti's
clinical development plan towards positioning CaPre® as a
first-in-class innovative regimen to help manage cardiometabolic
disorders, representing vast and growing markets," he added.
"This clinical regulatory approval is a major step towards value
creation for Acasti shareholders which can be appreciated when
benchmarking Acasti's market value against other companies evolving
in the same field," stated Xavier Harland, Chief Financial
Officer. "We hope that this positive development will
contribute to the success of Acasti's recently announced Rights
Offering," he added.
"Receiving the CTA acceptance from Health Canada is a
significant milestone resulting from more than two years of work by
the Acasti Team, from product development to preclinical studies
and submission," said Tina Sampalis, President. "It is worth
noting that the risk of the Acasti clinical program is reduced due
to our clinical trial results obtained over the years on CaPre®'s
precursor and on accumulated preclinical data demonstrating the
potential of CaPre® on cardiometabolic disorders, including a
significant effect on lipid and glucose management. The CaPre®
clinical phase II program will assess direct and complementary
clinical outcomes associated with cardiometabolic disorders and
will be supportive of additional clinical programs in Canada and in
the U.S.," she concluded.
Acasti recently received an award at the latest Genesis Gala
held by BioQuebec, an association of biotech and life science
companies from the Province of Quebec. Acasti was awarded the
Innovation Award of 2011 in recognition for the development of its
pharmaceutical products in the Over-the-Counter (OTC) and Medical
Food markets, respectively VectosTM and OnemiaTM, as well as for
its prescription drug candidate, CaPre®, currently in clinical
development. Acasti was also recently awarded with the Deka
Innovation Award by The Hellenic Board of Trade of Metropolitan
Montreal.
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 (Nasdaq:NEPT) (TSX-V:NTB) 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:
Bob Beaty
(888) 221-0915
bob@howardgroupinc.com
www.howardgroupinc.com
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