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Biotech / Medical : Vertex Pharmaceuticals (VRTX) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (595)	6/12/2002 9:37:22 AM
From: tuck	Read Replies (1) \| Respond to of 1169

>>CAMBRIDGE, Mass., June 12 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) announced today the initiation of a Phase I clinical trial with VX-702, a novel, orally administered inhibitor of p38 mitogen-activated protein (MAP) kinase, targeting the treatment of inflammatory diseases. The p38 MAP kinase enzyme regulates the production of key proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1 beta) and interleukin-6 (IL-6). Based on their mechanism of action, inhibitors of p38 MAP kinase could play a future role in the treatment of acute and chronic inflammatory diseases, including rheumatoid arthritis, osteoarthritis, and Crohn's disease. "The p38 MAP kinase enzyme represents a promising intervention point for inhibiting TNF-alpha and IL-1 beta in a highly targeted manner," stated John J. Alam, M.D., Senior Vice President of Drug Evaluation and Approval. "Injectable agents that inhibit TNF-alpha and IL-1 beta have emerged as clinically important strategies for controlling the onset and progression of inflammation. As an oral drug candidate that inhibits p38 MAP kinase and has potential for once daily dosing, VX-702 represents a potentially powerful and convenient treatment approach for a number of inflammatory diseases." VX-702 shows potent effects on lowering cytokine production and in decreasing the signs of arthritis in animal models of inflammation and arthritis. The activity of VX-702 in vitro and in animal models provides strong rationale for the clinical development of this compound. The Phase I double-blind, placebo-controlled, randomized clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of VX-702 in approximately 50 healthy volunteers. As part of the study, researchers will analyze blood samples to determine the ability of different doses of VX- 702 to inhibit experimentally induced cytokine production using specific biochemical assays. Vertex is conducting the study in Europe. Based on information from this study, Vertex expects to initiate studies in one or more inflammatory disease indications, including rheumatoid arthritis. Background Vertex is a leader in the development of novel anti-cytokine therapies for the treatment of inflammatory diseases. Last year, Vertex was first to demonstrate clinical proof of principle correlating inhibition of the novel target p38 MAP kinase with a significant, clinically relevant anti- inflammatory effect in the treatment of rheumatoid arthritis. MAP kinases are a family of structurally related enzymes that mediate intracellular signaling pathways and play an important role in the regulation of proinflammatory cytokines. Specifically, p38 MAP kinase regulates the production of TNF-alpha, IL-1 beta and IL-6 that occurs as part of acute and chronic inflammatory responses. VX-702, one of Vertex's second-generation p38 MAP kinase inhibitors, emerged as the result of focused efforts to discover and develop multiple drug candidates directed at p38 MAP kinase. Vertex and Kissei Pharmaceutical Co., Ltd., entered into a strategic alliance in 1997 to design, develop and commercialize orally active p38 MAP kinase inhibitors. Under the terms of this agreement, Vertex holds development and commercial rights in the United States and Europe for its p38 MAP kinase inhibitors. Kissei holds development and commercial rights in Japan and certain Asian countries for VX-702.<< snip Cheers, Tuck