PR Pharmaceuticals has announced that healthy volunteers were dosed with PulmoLAR (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.
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.