Mushroom Extract Receives IND From FDA

The Tradeworks Group, Inc., Brattleboro, VT, has been granted an Investigational New Drug (IND) number by FDA in conjunction with a government funded human clinical study on breast cancer for one of the company’s proprietary medicinal mushroom extracts. Tradeworks is the exclusive supplier of the patented maitake extract to be used in the multi-phase, three-year study. The same extract is marketed in North America by dietary supplement companies under the trade name MaitakeGold404®. Unlike most compounds approved for an IND, MaitakeGold 404 is not a drug, but rather an all-natural extract derived from the maitake mushroom. It is, however, being subjected to the same scrutiny as a drug for the purposes of this study.