March 25, 2004--Brattleboro, Vermont--The Tradeworks Group, Inc. of Brattleboro, Vermont is pleased to announce that one of the company’s proprietary medicinal mushroom extracts has been granted an Investigational New Drug number (IND) by the U.S. Food and Drug Administration in conjunction with a government funded human clinical study on breast cancer. Tradeworks is the exclusive supplier of the patented Maitake extract to be used in the multi-phase, three year study being conducted by one of the world’s foremost cancer research facilities. The same extract is marketed in North America by leading dietary supplement companies under the trade name MaitakeGold 404®.
Normally reserved for research on pharmaceuticals, an IND was sought for this patented Maitake extract due to both the serious nature of the study being conducted and the stature of the institution conducting the research. The FDA’s role in the development of a new drug begins when the drug’s sponsor has documented pharmacological activity, has conducted safety and toxicity research and wants to test its diagnostic or therapeutic potential in humans. In order to transport or distribute the substance across state lines for further testing, an IND must be obtained from the FDA, demonstrating its safety, purity, manufacturing processes and facilities and documenting that the substance will not expose humans to an unreasonable risk when used in early-stage clinical trials. Unlike most compounds approved for an IND, MaitakeGold 404® is not a drug, but rather an all natural extract derived from Maitake mushroom. It is, however, being subjected to the same scrutiny as a drug for the purposes of this study.
Company president Peter McNeary expressed his gratification at the product receiving the IND, saying “we at Tradeworks are very proud that our product, MaitakeGold 404®, was selected exclusively for the trial due to its outstanding research credentials, safety data and bioactivity.” Having received the IND, the study has recently commenced and will take place over the course of the next three years.