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LPT3-04™ Weight Loss Agent
Background. LPT3-04 is Oragenics’ small molecule weight-loss agent. As a natural substance, LPT3-04 is orally available and has an excellent safety and tolerability profile. The prevalence of people who are overweight has increased significantly in the past few decades, with huge public health costs attached to it. Only a small number of products are currently marketed that effectively help promote weight loss. The commercial potential for this novel small molecule, and its chemical analogs, for regulation of body weight is significant.
Technical Background. Cell culture studies and specific animal models have been used to identify the primary mechanism of action for promoting weight loss. LPT3-04 appears to target fat cells and, specifically, induce cell death in white fat cells. This effect occurs in a dose-dependent fashion.
Regulatory status. Oragenics is currently evaluating different formulations and delivery vehicles for consumer preference of its LPT3-04 product. The Company plans to conduct a clinical trial to support weight loss claims beginning during the second quarter of 2009. The active agent in LPT3-04 has been marketed prior to 1994, as a nutritional supplement, but with very different claims and daily dosage levels from those envisioned by Oragenics for its product. When ready, the LPT3-04 product will be initially launched in the U.S. as a nutritional supplement intended for use as an aid in weight reduction. A methods patent application was filed in November of 2005 covering the intended use of LPT3-04 for weight loss. A second patent application was filed in November 2008, with the intention of providing additional patent protection for this technology. If the planned clinical trial meets its primary endpoints regarding safety and effectiveness, the Company intends to launch LPT3-04 under its own brand name at some point during the second half of 2009.
