DEVELOPMENT OF A BOTANICAL ANTI-ARTHRITIS DRUG, PMI-001

DESCRIPTION (provided by applicant): An extract of the roots of Tripterygium wilfordii, a plant with a long history of medicinal use in China, demonstrated great promise as a potential prescription botanical drug for rheumatoid arthritis. In-vitro, in-vivo and human clinical studies performed in the U.S.A. and in China indicate that the extract of Tripierygium roots (PMI-001) is effective against arthritis and other autoimmune disorders. PMI-001 contains triptolide and other related molecules that inhibit IL-2 release and COX-2 transcription, a dual mechanism that is unique among current arthritis treatments. The main difficulty to PMI-001 development as a successful botanical drug has been obtaining a supply of roots that are consistent in quantity, quality and efficacy. The proposed work will establish large-scale greenhouse based hydroponic cultivation of Tripterygium in order to optimize PMI-001 safety and efficacy and assure its continuous and cost-effective supply. This will be accomplished through determining optimum conditions for plant propagation, cultivation, harvesting and extraction. In addition, analytical methods and efficacy bioassays will be developed and validated, establishing the framework for the future QAIQC methods and GMP procedures necessary for the FDA approval of this novel, safe and efficacious product.