FORT COLLINS, Colo., March 27 /PRNewswire/ -- PR Pharmaceuticals, Inc. (PRP) announced today that healthy volunteers were dosed with PulmoLAR(TM) (2-methoxyestradiol - 2ME) in a Phase I clinical study. The double-blind, placebo-controlled clinical study is designed to assess the safety, tolerability and pharmacokinetics of a subcutaneous injection of PulmoLAR.
"Initiation of this Phase I clinical study for PulmoLAR is a significant milestone for our company and a pivotal step in the development of this important product which we hope leads to a novel treatment for pulmonary arterial hypertension (PAH)," said Steve Howe, PRP's Chairman and CEO. "Our executive team recognizes and appreciates the tremendous effort and dedication of our employees in the successes which have brought PulmoLAR to this stage of development."
Stevan P. Tofovic, M.D., Ph.D., Assistant Professor at the University of Pittsburgh School of Medicine and key investigator/inventor on the use of 2ME for PAH stated, "It is very gratifying to see our collaborative efforts with PRP come to fruition as PulmoLAR enters the clinical phase of development. We're optimistic that PulmoLAR may provide significant therapeutic benefits in the treatment of PAH, a devastating disease for which additional therapies are desperately needed."
The active ingredient in PulmoLAR is 2ME. 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.
About PR Pharmaceuticals, Inc.
PRP is a biopharmaceutical company developing, manufacturing and commercializing bioactive compounds in its injectable sustained-release technologies. The Company 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. For more information, please see www.prpharm.com
PulmoLAR(TM) is a trademark of PR Pharmaceuticals, Inc.
Media contact: Dr. Claude Piche (970) 484-5560
PR Pharmaceuticals, Inc.