JAMESBURG, N.J., Aug. 19 /PRNewswire/ -- Phytomedics Inc. today announced the publication of the results of a 6 month, Phase 2b clinical trial with an extract of Tripterygium wilfordii Hook F (TwHF) to be developed as PMI-001, in patients with rheumatoid arthritis, in the August 18, 2009 issue of the Annals of Internal Medicine.
In an article entitled "Comparison of Tripterygium wilfordii Hook F versus Sulfasalazine in the Treatment of Rheumatoid," the TwHF extract or thundergod vine was shown to be clinically superior to sulfasalazine (SSZ) using the standard American College of Rheumatology (ACR) criteria with a comparable safety profile. "The results of this clinical trial are very impressive and suggest that a remedy that was first identified in China has real promise to have a major impact on rheumatoid arthritis care world-wide. Although many subjects with rheumatoid arthritis have greatly benefited by the newer biologic agents, there remains an unmet medical need for those people who are unable to receive these agents or have limited access because of financial considerations. For those individuals, as well as many others with rheumatoid arthritis who have active disease despite receiving current therapy, the results of this clinical trial indicate that the extract of Tripterygium wilfordii may provide a new therapeutic alternative. This is very good news for these individuals as well as their families," said Dr Peter Lipsky, Chair of the Phytomedics Scientific Advisory Board. "PMI-001 is an orally absorbable agent that appears to have activity similar to some of the currently available biologic agents. This clinical impact combined with both an acceptable side effect profile and oral dosing make this botanical drug product a unique new therapeutic agent for subjects with rheumatoid arthritis."
Details of the Trial
This randomized, double-blind, active-controlled 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."
PMI-001 is a novel, oral, disease modifying anti-rheumatic drug currently being developed as a natural pharmaceutical alternative in rheumatoid arthritis therapy. PMI-001 exerts its potent anti-inflammatory and immunosuppressant activities through unique modes of action. Potential applications of this botanical drug candidate beyond rheumatoid arthritis include a wide range of auto-immune disorders including lupus, psoriasis, inflammatory bowel disease and multiple sclerosis.
Phytomedics, Inc. is a clinical stage biopharmaceutical company with a novel portfolio of drugs and consumer products solely derived from plant sources. Through this proprietary technology platform, the Company has produced a broad pipeline of lead product candidates, several of which are in clinical development. Founded by Professor Ilya Raskin, Ph.D., presently the company's Chief Scientific Officer, Phytomedics Inc. conducts most of its discovery activities at the Biotech Center of Rutgers University. Phytomedics has supported the development of PMI-001 and in collaboration with Phytomedicinal Greenhouses (PMG), has developed a sophisticated approach to agricultural optimization. This is the first completely standardized botanical preparation of TwHF that is now ready to enter pivotal trials in rheumatoid arthritis.
|SOURCE Phytomedics, Inc.|
Copyright©2009 PR Newswire.
All rights reserved