STANDARDIZED AND IMPROVED SAW PALMETTO PRODUCT

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We propose to develop an improved Saw Palmetto product which can be manufactured in standardized and reproducible manner, and in strict accordance with current Good Manufacturing Practices (cGMP) of the FDA. Saw palmetto, derived from a native American palm tree Serenoa repens, has been clinically proven to be as effective as conventional medications in providing symptomatic relief for benign prostatic hyperplasia (BPH), a type of non-malignant prostate enlargement that is common in older men. This condition typically causes frequent urination. The U.S. marketplace is estimated to be $1.3 billion annually. As the population ages, the marketplace is expected to expand. We propose to improve the quality and standardize the manufacturing of Saw Palmetto by utilizing supercritical fluids and near-critical fluids w/wo polar cosolvents such as alcohols (SuperFluids(TM)). These fluids are gases such as carbon dioxide which when compressed, exhibit enhanced thermodynamic properties that can be "fine-tuned" for rapid and selective extraction of bioactive molecules. In Phase I, we plan to establish "best" conditions for the selective SuperFluids(TM) extraction and chromatographic purification of biologically active components. In Phase II, we plan to initiate pre-clinical studies, scale-up manufacturing, file an IND, and conduct clinical trials on the standardized Saw Palmetto product. PROPOSED COMMERCIAL APPLICATIONS: This investigation should lead to the development of improved Saw palmetto product which can be manufactured to meet the cGMP requirements of the FDA's IND process. Thee is a rapid growth of interest in and use of more natural and alternative solutions such as Saw palmetto in the $1.3 billion marketplace for benign prostatic hyperplasia (BPH).