FORT COLLINS, Colo., Dec. 20 /PRNewswire/ -- PR Pharmaceuticals, Inc. (PRP), announced today that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the Company's first clinical product, PulmoLAR(TM) (2-methoxyestradiol) for the treatment of pulmonary arterial hypertension (PAH).
"This IND for PulmoLAR is a milestone for our company and an important step in our development of this novel therapy. The data that have and continue to be generated in animal models of PAH and other cardiovascular injury lend strong support to this development initiative. Recently, we've generated a considerable body of important safety information that encourage us to begin human studies with our proprietary low-volume, sustained-release injectable formulation," said Dr. Claude Piche, PRP's Vice President of Clinical Development and Regulatory Affairs.
Stevan P. Tofovic, M.D., Ph.D., Assistant Professor at the University of Pittsburgh School of Medicine and principal investigator on the use of PulmoLAR in animal models of PAH, stated, "Our work in numerous animal models of cardiovascular injury, and in models of PAH in particular, indicates treatment with PulmoLAR has a dramatic effect in improving survival, reducing the damage to the arteries of the lungs and preventing subsequent right heart failure. We've also shown reduced injury and significant improvements in survival in a recently completed study in an animal model of PAH in which we compared 2-methoxyestradiol to some of the leading drugs used to treat PAH in humans. These results are very encouraging and we are excited to see PulmoLAR progress to clinical testing."
The active ingredient in PulmoLAR is 2-methoxyestradiol (2ME), an endogenous, non-estrogenic metabolite of estradiol. 2ME has multiple mechanisms of action, many of which are particularly 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. Animal studies conducted to date suggest a single, low-volume injection may provide therapeutic levels of drug for one month or more. In April 2005, Orphan Drug Status designation was granted by the FDA for use of PulmoLAR for the treatment of pulmonary arterial hypertension.
About PR Pharmaceuticals, Inc.
PR Pharmaceuticals, Inc. (PRP) is a privately held biopharmaceutical company focused on developing, manufacturing and commercializing bioactive compounds in sustained-release formulations. The Company specializes in injectable, biodegradable formulations and has a significant intellectual property position in the encapsulation of large molecules such as proteins and peptides as well as encapsulation of classic small molecules into biodegradable microparticles. PRP is applying compelling and patented technology to create a diverse range of candidate pharmaceutical products to address unmet medical needs.
PulmoLAR(TM) is a trademark of PR Pharmaceuticals, Inc.
PR Pharmaceuticals, Inc.