STANDARDIZED AND IMPROVED SAW PALMETTO PRODUCT

我们建议开发一种改进的锯棕榈产品，该产品可以以标准化和可重复的方式生产，并严格按照FDA现行的良好生产规范（cGMP）。锯棕榈，来自美国本土的棕榈树Serenoa repens，已被临床证明是有效的传统药物在提供症状缓解良性前列腺增生（BPH），一种类型的非恶性前列腺肿大，是常见的老年男性。 这种情况通常会导致频繁排尿。美国市场估计每年为13亿美元。随着人口老龄化，市场预计将扩大。我们建议通过利用超临界流体和近临界流体w/w极性共溶剂如醇（SuperFluids（TM））来提高锯棕榈的质量并使其生产标准化。这些流体是气体，例如二氧化碳，当压缩时，其表现出增强的热力学性质，其可以被“微调”以快速和选择性地提取生物活性分子。在第一阶段，我们计划建立选择性SuperFluids（TM）提取和色谱纯化生物活性成分的“最佳”条件。 在第二阶段，我们计划启动临床前研究，扩大生产规模，提交IND，并对标准化锯棕榈产品进行临床试验。拟议的商业应用：本研究应导致改进锯棕榈产品的开发，该产品的生产应符合FDA IND工艺的cGMP要求。 在13亿美元的良性前列腺增生（BPH）市场上，人们对更天然的替代解决方案（如锯棕榈）的兴趣和使用正在迅速增长。

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).