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Phytomedics Inc. Announces Publication of the Phase 2b Clinical Trial Results of an Extract of the Chinese Herbal Remedy Tripterygium wilfordii Hook F in Rheumatoid Arthritis
Date:8/19/2009

d study was conducted at 11 sites in the U.S., under the auspices of the National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Patients received the TwHF extract 180 mg/day, divided TID (n=60) or SSZ 2 g once daily (n=61) for 24 weeks. The primary endpoint of the study was a 20% improvement in disease activity by ACR criteria (ACR20).

At six months 67.6% of PMI-001-treated patients vs. 36.0% of SSZ-treated patients achieved at least a 20% improvement in disease activity (p=0.02). In the TwHF group, ACR 50 and ACR 70 responses were observed in 54.1% and 37.8% of patients. In the SSZ group, both ACR50 and ACR70 responses were 4.0% (p<0.001 for all comparisons). Significant improvement was seen with all endpoints as early as 2 weeks, including physical function as measured by the HAQ disability score. Patients receiving TwHF had no progression of mean joint space narrowing and erosion scores.

The most common adverse events in both treatment arms were gastrointestinal tract disturbances. Serious adverse events occurred in 3 patients on PMI001 and 7 patients on SSZ. Discontinuations for AEs occurred in 8 (13%) PMI001 patients and 17 (28%) SSZ patients.

Despite recent therapeutic advances, there remains significant unmet medical need for novel alternative therapies for many patients with rheumatoid arthritis. Many of these patients, even after treatment with multiple oral and parenteral drugs, continue to experience uncontrolled pain, joint swelling, fatigue, and impaired physical function. Dr. Laurie Smaldone, President and CEO of Phytomedics Inc. added "We are very pleased with the outcome from this study. We look forward to meeting with FDA to discuss development plans for PMI-001."

About PMI-001

PMI-001 is a novel, oral, disease modifying anti-rheumatic drug currently being developed as a natura
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SOURCE Phytomedics, Inc.
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