P38 inhibitor is moving forward.
Is my perception wrong, but seams to me that *street* love this program! :(
Or they are still digesting importance of viral RNA level in HCV trial.
What if 497 did have RNA level reduction at 400 mg dose? Or based on safety data they can increase dose to 600 or 800 mg/day?
biz.yahoo.com
Vertex Begins Pilot Phase II Clinical Trial of VX-745, p38 MAP Kinase Inhibitor for the Treatment of Inflammatory Disease
CAMBRIDGE, Mass., Nov. 2 /PRNewswire/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - news) announced today that it has begun an exploratory Phase II trial of the investigational drug VX-745, the Company's orally administered p38 mitogen-activated protein (MAP) kinase inhibitor, in patients with rheumatoid arthritis. VX-745 is being developed by Vertex Pharmaceuticals in the United States and Europe for the treatment of inflammatory diseases. Vertex's partner Kissei Pharmaceutical Co., Ltd. of Matsumoto-City, Japan will develop the compound in Japan and certain Asian countries.
''This trial will provide further information about the potential for VX-745 in the treatment of rheumatoid arthritis, and help us to design larger studies aimed at evaluating the safety and efficacy of the drug,'' said Dr. Vicki Sato, Senior Vice President of Research and Development and Chief Scientific Officer of Vertex. ''With VX-745 entering Phase II, we now have six drug candidates in Phase II clinical development targeting a range of medically under-served diseases. We look forward to further developing and advancing our product pipeline.''
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. P38 MAP kinase is a specific enzyme that regulates the production of interleukin-1 beta (IL-1 beta), interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF alpha) as part of acute and chronic inflammatory responses. VX-745 has been shown to slow disease progression in animal models of immune-mediated arthritis.
The exploratory Phase II trial announced today is a 28-day study designed to test the tolerability and pharmacokinetics of VX-745 in ten patients with rheumatoid arthritis. The study is being conducted in Europe. The trial will also assess the pharmacodynamic activity of VX-745, and clinical disease activity markers will be monitored. |
