Sep 15 2009
Palatin Technologies, Inc. (NYSE Amex: PTN) announced that a poster on clinical trial results with PL-3994, its product for heart failure, will be presented today at the 13th Annual Scientific Meeting of the Heart Failure Society of America in Boston.
The poster presents data from a Phase 2A study of PL-3994 in controlled hypertensive volunteers who were taking antihypertensive medications and otherwise healthy. The study is preparatory to planned future trials, in which heart failure patients will receive daily subcutaneous injections of PL-3994 with the objective of reducing the re-hospitalization rate in heart failure patients after an acutely decompensating event.
"This study supports our hypothesis that PL-3994 can safely be administered to patients receiving antihypertensive medications, such as heart failure patients," said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin. "We are excited by the potential for PL-3994, which is the only reported natriuretic peptide drug being developed for daily, subcutaneous, self-administration by heart failure patients."
Key Results
PL-3994 was administered by subcutaneous injection to volunteers with controlled hypertension, with key results including:
- Increases in plasma concentrations of cyclic guanosine monophosphate (cGMP) levels, a pharmacological response consistent with the effects of endogenous natriuretic peptides on cardiovascular function, similar to results seen in an earlier Phase 1 study.
- A maximum tolerated dose of 0.3 micrograms per kilogram, based upon a pre-specified decrease in blood pressure.
- PL-3994 was well tolerated, with no serious adverse events observed in the study population.