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.
