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PharmaIN and Pacific Northwest Diabetes Research Institute Announce Preclinical Research Collaboration to Study New Drug Combination to Treat Diabetes |
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SEATTLE, WA – (May 28, 2008) – PharmaIN Corporation and Pacific Northwest Diabetes Research Institute (PNDRI) announced today that they are collaborating on a project to evaluate the benefit of combining PharmaIN's long-acting formulation of native, human GLP-1 (PGC GLP-1) with sitagliptin, a dipeptidyl peptidase IV (DPP-IV) inhibitor marketed by Merck under the brand name JANUVIA™. "What we're looking for with this project is to improve beta cell function with this drug combination. Beta cells are the cells responsible for producing insulin. Improving their function is one of the critical goals in treating diabetes," said R. Paul Robertson, MD, President and Scientific Director for PNDRI. "Our collaboration with PharmaIN will test the hypothesis that combining sitagliptin with PGC GLP-1 will lead to improved beta cell performance." "Our formulation is very unique – being the only native, all human sequence long-acting formulation of GLP-1 under development. We believe that our product is the only one that might benefit – have synergy – from the combination with a product like sitagliptin. Combining PGC GLP-1 with a DPP-IV inhibitor has a number of significant potential benefits," stated Elijah Bolotin, PhD, President and CEO for PharmaIN. "Our real hope is that the combination leads to better therapeutic response – when compared to single agent therapy." The combination of a PGC GLP-1 formulation with a DPP-IV inhibitor (e.g. sitagliptin) has the potential to raise GLP-1 in the blood to a more beneficial level, as compared to levels achieved by a DPP-IV inhibitor alone. In addition, the combination may lengthen the half-life of PGC-GLP-1 in vivo and further improve PGC GLP-1 pharmacokinetics curve – potentially improving efficacy and reducing the risk of side effects. The combination may also lower the amount of drug used to achieve the same benefit and sitagliptin could also work synergistically with PGC-GLP-1 by increasing the blood level of other DPP-IV sensitive incretin hormones like GIP. Overall, the combination could lead to better control of blood sugar, better control of body weight, and/or improved beta cell health than the use of PGC-GLP-1 or sitagliptin alone. About PNDRI: PNDRI is an independent non-profit discovery and clinical research center located in Seattle and founded in 1956. The mission of PNDRI is to support and conduct basic and clinical studies that lead to the prevention and cure of diabetes and its complications. PNDRI's acclaimed team of 85 scientists is committed to making and applying discoveries that lead to improvement of health for people everywhere living with diabetes. About PharmaIN: PharmaIN Corporation, headquartered in Seattle, WA, is the leader in developing affinity-based drug delivery solutions for biotech and pharmaceutical applications. The Company is developing superior drug therapies using its proprietary, novel drug delivery platform - "Protected Graft Co-polymer" (PGC™). The Company's lead product, called PGC GLP-1, is in late state preclinical testing and is being readied for an IND submission to FDA for the treatment of Type 1 and Type 2 diabetes. Other products in early stage preclinical development include a novel, long-acting formulations of: native human insulin (for basal use in diabetes), lysostaphin for staphylococcal infection, and vasoactive intestinal peptide for inflammatory disease. The Company is also investigating the use of its proprietary drug delivery technology to deliver small, inhibitory RNA (i.e. "siRNA") for multiple disease opportunities. The Company's drug delivery system uses proprietary, fully biodegradable, and biocompatible carrier molecules that reversibly bind drug "payloads" thus enabling innovative drug therapies for human diseases. Using the Company's unique approach and technology, drug payloads are bound non-covalently to a carrier and then, after patient administration (usually by subcutaneous injection), preferentially released in vivo at the target/receptor site for optimal drug effect - including easier use, lower side effects, and superior efficacy. PharmaIN aims to enable new, value-added drug therapies and improve "old" drugs through the use of its platform. The Company's current focus is on injected drugs and anticipates future development of drug formulations that can be delivered via mucosal routes (e.g. through the lungs or sublingual in the mouth). Visit www.pharmain.com. About PGC GLP-1: PGC GLP-1 is a novel formulation of the native (natural form) human sequence peptide GLP-1 (glucagon-like peptide 1) using the Company's proprietary drug delivery technology, PGC™ (Protected Graft Copolymer). The formulation is expected to be dosed weekly by patients. The PGC technology increases the half-life of native GLP-1 hundreds-fold while maintaining natural biological activity of the peptide. PGC GLP-1 is in late stage preclinical testing for the treatment of type 1 and type 2 diabetes. PGC GLP-1 has the potential to treat a number of conditions, including diabetes, obesity, certain cardiovascular conditions, and medical conditions where patients need improved glycemic control. PGC GLP-1 is part of the new therapeutic class called "incretins". This class includes natural human incretins, non-human incretin analogs and incretin mimetics, drugs all intended to improve insulin secretion in patients. The natural sequence human incretin GLP-1 is secreted by the gastrointestinal tract in response to food intake. GLP-1 acts as an incretin to lower blood glucose via stimulation of glucose-dependent insulin secretion and insulin production from islet beta cells. GLP-1 also exerts actions independent of insulin secretion, including inhibition of gastric (stomach) emptying and acid secretion, reduction in food ingestion and glucagon (a hormone important in increasing levels of glucose in the blood) secretion, and stimulation of beta cell proliferation (1). Beta cells are the cells responsible for insulin production. About Diabetes: According to the American Diabetes Association there are 20.8 million people in the United States who have diabetes – about 7% of the population. While an estimated 14.6 million patients have been diagnosed with diabetes, 6.2 million people are unaware that they have the disease. The two major types of diabetes are called Type 1 and Type 2 diabetes. Type 1 diabetes develops when the body fails to produce insulin as a result of the body's immune system destroying the insulin producing beta cells. Type 2 diabetes develops when insulin resistance combined with relative insulin production insufficiency results in abnormally high blood glucose levels. JANUVIA™ is a trademark of Merck & Co., Inc. A research grant from Merck provided support for the collaboration. Forward-looking StatementsThis press release contains forward-looking statements, including but not limited to statements about business strategies, services, market potential, future financial performance, potential clinical and scientific outcomes, and other matters that involve many risks and uncertainties which could cause actual results to differ materially from such forward-looking statements. For this purpose, any statements contained herein that are not statements of historical fact are deemed forward-looking statements. Terms such as "believe", "expect", "anticipate", "plan" and similar expressions generally denote forward looking statements. These forward-looking statements are based on the Company's current information, beliefs, assumptions and expectations, and are intended to explain the Company's objectives and strategies. Potential risks and uncertainties include: the continued health of the biotechnology and pharmaceutical industries and the overall economy; changes in external market factors; emergence of new competitors and technologies; changes in laws and regulations; access to capital resources; changes in the Company's business or growth strategy; the ability of the Company to successfully develop and obtain regulatory approval for its products; changes in strategic relationships; and other competitive factors. Should one or more of these risks or uncertainties materialize, or should the underlying information, beliefs, assumptions or expectations prove incorrect, actual results may differ materially from these forward looking statements. Consequently, these forward looking statements do not assure or guarantee the Company's future performance. Actual results or activities or actual events or conditions could differ materially from those estimated or forecasted by the Company in such forward-looking statements, due to a variety of factors, some of which may be beyond the control of the Company. The Company is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. SOURCE: PharmaIN Corporation, Seattle, WA 98122 www.pharmain.com REFERENCES: (1) Gastroenterology, 2002; 122:31-544. |
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