PR Pharmaceuticals has announced the issuance of U.S. Patent No. 6,998,395 covering 2-methoxyestradiol (2ME) for the treatment of diabetes.
The patent which is assigned to the University of Pittsburgh has been exclusively licensed to PRP. The drug, known as PulmoLAR, containing 2ME as active ingredient, is currently developed by PRP for the treatment of pulmonary arterial hypertension (PAH).
"We have demonstrated in an animal model of the metabolic syndrome that treatment with 2ME can significantly attenuate much of the pathology associated with the metabolic syndrome," said Edwin K. Jackson Ph.D., Professor at the University of Pittsburgh School of Medicine and co-inventor of this recently issued patent. "Treatment with 2ME resulted in reduced glycated hemoglobin levels, improved response to an oral glucose tolerance test and reduced kidney damage as shown by a significant reduction in proteinuria. These data are very encouraging as we continue to explore the mechanism of action and gain a deeper understanding of the potential applications of this novel compound."
"The data generated to support this patent suggest 2ME has potential in areas beyond Pulmonary Hypertension," said Dr. Claude Piche, PRP's vice-president of Clinical Development and Regulatory Affairs. "We continue to investigate this and other potential uses of 2ME and further expand our IP portfolio."
The active ingredient in PulmoLAR is 2ME, an endogenous non-estrogenic metabolite of estradiol. 2ME has multiple mechanisms of action, many of which are relevant to PAH. In vitro studies have demonstrated 2ME reduces endothelial cell production of endothelin-1 and increases synthesis of prostacyclin. 2ME is also a potent antiproliferative agent. PulmoLAR is PRP's proprietary sustained release injectable formulation. Phase I studies with PulmoLAR are planned for 2006.