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| Acasti Pharma Announces the Initiation of a Second Phase II Clinical Study and Consolidation of its IP Position |
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| Monday, December 05 2011 | |||||||||
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Acasti Pharma Announces the Initiation of a Second Phase II Clinical Study and Consolidation of its IP Position “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 (TSXV: 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 astaxanthin, a potent antioxidant. Acasti Pharma is focusing initially on treatments for chronic cardiovascular and cardiometabolic conditions within the over-the-counter, medical food and prescription drug markets. 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. About NeuroBioPharm Inc. NeuroBioPharm is pursuing pharmaceutical neurological applications, and a clinical study for a medical food product with a multinational partner is already initiated. The development of a prescription drug candidate is currently in progress. Advanced clinical development and commercialization is planned to be carried out with multinational partners. "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."
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