Animal studies conducted to date suggest a single low-volume injection may provide therapeutic levels of drug for one month or more. If the IND is accepted it will allow the company to begin testing the drug in humans.
In April 2005, orphan drug status designation was granted by the FDA for use of PulmoLar 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,” said Dr Claude Piche, PRP’s vice president of clinical development and regulatory affairs.
A recently completed study in an animal model of PAH, which compared the active ingredient of PulmoLar with some of the leading drugs used to treat the disease in humans, showed that the drug reduced injury to the arteries of the lung, and produced significant improvements in survival.