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-controlle
|SOURCE Phytomedics, Inc.|
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