Development of an Anti-Diabetes Botanical Nutraceutical

描述（由申请人提供）：这是PMI-5011（一种标准化植物提取物，由Phytomedics Inc.开发）临床前开发的修订提案。和罗格斯大学。PMI-5011可有效降低胰岛素缺乏和胰岛素抵抗动物的血糖，不会引起低血糖，安全无毒。所有数据表明，PMI-5011是糖尿病或糖尿病前期疾病患者的有效营养补充剂。初步结果表明，PMI-5011特异性地影响糖尿病大鼠的肝脏基因表达，并促进胰岛素介导的肌肉组织葡萄糖摄取，作为使糖尿病正常化的潜在手段。 Phytomedics将使用SBIR资金完成PMI-5011的必要临床前研究，并为剩余的临床前和临床测试生产足够的标准化和优化的PMI-5011材料。Phytomedics还将确认PMI-5011活性成分的身份，并确定用于源植物栽培的最佳水培温室方法。Phytomedics将在本提案的第2阶段进行PMI-5011的有限临床试验。该提案的第三阶段将涉及与商业合作伙伴一起使用由Phytomedics独家提供的PMI-5011进行PMI-5011的全面商业化。

DESCRIPTION (provided by applicant): This is a revised proposal for the pre-clinical development of PMI-5011, a standardized botanical extract, developed by Phytomedics Inc. and Rutgers University. PMI-5011 effectively lowers blood glucose in insulin deficient and insulin resistant animals, does not cause hypoglycemia, and is safe and non-toxic. All data suggest that PMI-5011 is an efficacious nutritional supplement for those suffering from diabetes or prediabetic conditions. Preliminary results demonstrate that PMI-5011 specifically affects hepatic gene expression in diabetic rats and promotes insulin mediated glucose uptake by muscle tissues as potential means of normalizing glycemia. Phytomedics will use the SBIR funds to complete the necessary pre-clinical investigation of PMI-5011 and to produce a sufficient supply of the standardized and optimized PMI-5011 material for the remaining preclinical and clinical testing. Phytomedics will also confirm the identity of the active ingredients of PMI-5011 and determine optimal hydroponic greenhouse methods for the source plant cultivation. Phytomedics will conduct limited clinical trials of PMI-5011 in Phase 2 of this proposal. Phase 3 of this proposal will involve the full-scale commercialization of PMI-5011 with a commercial partner, using PMI-5011 exclusively supplied by Phytomedics.