Acasti Pharma Inc. Receives Health Canada Clearance for an Open-Label Phase II Hypertriglyceridemia Trial
17 Outubro 2011 - 10:00AM
Acasti Pharma Inc. (Acasti) (TSX.V:APO), a subsidiary of Neptune
Technologies & Bioressources Inc. (Neptune), has received
another positive response from Health Canada regarding its second
Clinical Trial Application (CTA), thereby allowing the initiation
of an open-label 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 an
open-label phase II human clinical trial to investigate the dose
response effect 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 early 2012. The design
of the study is an open-label 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.
"We are pleased with Health Canada's authorization; it
represents another milestone in Acasti's clinical development
plan towards positioning CaPre® as a safe and efficacious
first-in-class regimen to help manage cardiometabolic disorders"
indicated Pierre Lemieux, Ph.D., Chief Operating Officer.
"The ability to initiate this additional Phase II study allows
Acasti to generate near-term data to guide our regulatory and
clinical strategy. We believe the broad potential activity and
safety of CaPre in the wider dyslipidemic population will
distinguish our drug from others in this arena. This effort will
also help form the basis of our future clinical work in the US and
Europe" said Harlan Waksal, M.D., Executive Vice President.
"Acasti has made significant progress over the last few months
including this CTA acceptance as well as the recently announced
initiation of enrolment in our first Phase II double-blind placebo
controlled clinical trial. In addition to our drug development
initiatives, the composition of Acasti's active pharmaceutical
ingredients is now patented through Acasti's exclusive worldwide
license from Neptune Technologies and Bioressources. Neptune was
recently granted from the U.S. Patent and Trademark Office
("USPTO") a new patent (U.S. No. 8,030,348) covering omega-3
phospholipids comprising polyunsaturated fatty acids. Furthermore,
Acasti recently completed the "Rights Offering" raising over $8
million dollars" said Tina Sampalis, M.D., Ph.D., President.
About Acasti Pharma Inc.
Acasti (TSX-V:APO) 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) and (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:
Dave Burwell
(888) 221-0915
dave@howardgroupinc.com
www.howardgroupinc.com
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