Acasti Pharma Announces the Initiation of a Second Phase II Clinical Study and Consolidation of Its IP Position
2011年12月5日 - 10:00PM
Acasti Pharma Inc. (Acasti) (TSX-V:APO), a subsidiary of Neptune
Technologies & Bioressources
Inc. (Neptune), announces the extension of its clinical
development program by enrolling the first patients in its
second phase II clinical trial designed to assess the
safety, efficacy and dose response of its prescription
drug candidate, CaPre®, for patients with
hypertriglyceridemia.
"The initiation of this clinical trial is an important milestone
in our clinical and business development plan. The open-label
design and shorter treatment period of this study facilitates a
faster recruitment and earlier outcome data than our double-blinded
phase II clinical trial conducted in parallel," stated Dr. Harlan
Waksal, Executive Vice-President. "We expect to be able to
communicate to regulating authorities, as well as to the market,
the benefits of CaPre® on patients with hypertriglyceridemia within
a shorter timeframe. Furthermore, it will allow the Acasti
team to prepare for the next step of its clinical development plan
and be ready to file an IND with the FDA to enter into US clinical
trials," he added.
"The addition of our second phase II clinical trial is key to
our development strategy as it should not only accelerate our
clinical progress, but provide us important information on
patients' response to different treatment doses of CaPre®," stated
Dr. Tina Sampalis, President. "We expect the open-label trial
results to confirm our hypothesis that CaPre® is effective at a
smaller dose and at a better dosage regimen than competitive
products, increasing patient compliance, a major factor for the
viability of a chronic regimen," she added.
Acasti's intellectual property portfolio has recently been
reinforced with the issuance of Neptune's US patents No. 8,030,348
(the "`348 patent") and No. 8,057,825 (the "`825 patent"), on which
Acasti already has exclusive licensing rights for pharmaceutical
cardiovascular applications. The two patents are valid at least
until 2024. The `348 patent covers the composition of novel omega-3
phospholipids for human consumption, synthetic and/or natural,
extracted from marine and aquatic biomasses, regardless of the
extraction process. Omega-3 Phospholipids are the main active
ingredient in all Acasti's products. The `825 patent protects
and provides Acasti with the exclusive pharmaceutical use of krill
extracts in the U.S., as method for reducing cholesterol, platelet
adhesion and plaque formation.
"The rights to those two patents are especially valuable to
Acasti, representing important assets as well as very significant
value drivers in eventual partnerships on the company's products
under development," stated Dr. Tina Sampalis.
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
Neptune Wellness Solutions (NASDAQ:NEPT)
過去 株価チャート
から 9 2024 まで 10 2024
Neptune Wellness Solutions (NASDAQ:NEPT)
過去 株価チャート
から 10 2023 まで 10 2024