Phase II Study on Saw Palmetto for BPH.
A Phase II double-blind study of saw palmetto for benign prostatic hyperplasia (BPH), using about 50 patients, will begin shortly at centers in four locations in the U.S. PharmaPrint,(TM) the company conducting the study, submitted the investigational new drug application (IND) to the FDA in July 1997, the first-ever submission to the FDA for an herbal product based on the PharmaPrint Process. According to Elliot Friedman, Chairman and CEO of PharmaPrint, the start of the Phase II trial marks another important step toward bringing an entirely new generation of herbal medicines to market -- creating truly standardized herbal products based on the demonstrable bioactive components in each botanical. An IND for St. John's wort is planned for submission in December of this year.
According to the company, the PharmaPrint Process provides the technology necessary to 1) identify, quantify, and control the bioactive components of an herbal pharmaceutical; 2) determine the activity of each component in a specific bio-assay; and 3) ensure the components are present in predetermined quantities for a given manufactured herbal batch, using chemistry and biology to define specifications for consistent manufacturing.
[PharmaPrint press release. Sept. 8, 1997.]
Article copyright American Botanical Council.
By Barbara A. Johnston