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Alantos Pharmaceuticals Holding, Inc. Initiates Phase 1 Clinical Studies With Lead Compound For Type II Diabetes


8/16/2006 9:22:30 AM

CAMBRIDGE, Mass., Aug. 16 /PRNewswire/ -- Alantos Pharmaceuticals, a privately held biopharmaceutical company based on the discovery and development of small molecule drugs with a focus on type II diabetes and Osteoarthritis/inflammation, today announced that it has initiated a Phase 1 clinical study with its first clinical candidate, ALS 2-0426, an orally active, small molecule inhibitor of Dipeptidyl Peptidase IV (DPP-IV), for the treatment of type II diabetes.

"The initiation of this clinical trial marks a significant milestone for Alantos as we transition our internal research into product development," said Keith Dionne, Ph.D., Chief Executive Officer of Alantos. "DPP-IV inhibitors represent a new class of treatment for diabetes and one that has received much recognition from the pharmaceutical industry. Based on pre-clinical studies, we believe ALS 2-0426 offers significant advantages compared to other products being developed today, including superior efficacy and safety, making it best in class among all DPP-IV inhibitors." Further Dr. Dionne added: "This program highlights Alantos' capabilities in drug design and our ability to move a compound expeditiously through development. ALS 2-0426 was first discovered in April 2005, declared as clinical candidate in June 2005 and entered the clinic in July 2006. Few companies can advance molecules this quickly."

Designed in two parts, the initial double-blind, placebo controlled Phase 1 clinical study will enroll approximately 50 healthy male volunteers in one center in the U.S. The first study uses a single, ascending oral dose, sequential cohort design and will be followed by a multiple dose study also in healthy volunteers. The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ALS 2-0426. Professor Werner Scherbaum, Director of the German Diabetes Institute commented: "I am excited to see ALS 2-0426 begin clinical development and look forward to contributing to the exploration of its therapeutic potential."

DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin. DPP-IV inhibitors represent a novel approach to the treatment of type II diabetes.

Currently, there are an estimated 200 million people world-wide suffering from diabetes; 90% of which have adult onset, or type II diabetes. In type II diabetes, either the pancreas does not produce sufficient insulin or the body fails to respond properly to insulin. The global market for pharmaceutical treatment is estimated at $11 billion and is expected to grow by more than 50 percent by the end of the decade.

About The Company:

Alantos Pharmaceuticals is a chemistry-driven biopharmaceutical company with a broad proprietary pipeline of small molecule drugs focused in the area of type II diabetes and Osteoarthritis/inflammation. The Company has discovered a series of breakthrough, highly selective, Metalloprotease (MMP) inhibitors. Alantos is utilizing this proprietary platform of selective MMP inhibitors to develop novel small molecule compounds, free of the side-effects previously observed in broad-spectrum MMP inhibitors developed by others. The Company's lead program in this area is in osteoarthritis but it is exploring the application of the platform in several other tissue remodeling pathways, such as rheumatoid arthritis, liver fibrosis, cardiovascular, chronic wound healing and cancer. With headquarters and development in Cambridge, Massachusetts, and discovery in Heidelberg, Germany, the Company currently employs 45 people. For more information on the Company, please visit: www.alantos.com.

Alantos Pharmaceuticals

CONTACT: Matthias Jaffe, Chief Financial Officer, of AlantosPharmaceuticals Holding, Inc., +1-617-301-5615; or Rhonda Chiger,Investors, +1-917-322-2569, or Tina Posterli, Media, +1-917-322-2565, bothof Rx Communications Group, for Alantos Pharmaceuticals



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