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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.
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"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:
About PL-3994
PL-3994 is a natriuretic peptide-A receptor agonist compound developed by Palatin Technologies for treatment of heart failure. PL-3994 has an extended half-life, with reduced affinity for natriuretic peptide clearance receptors and increased resistance to neutral endopeptidase, an endogenous enzyme that degrades natriuretic peptides. PL-3994 is being developed as a subcutaneously administered drug, and is well absorbed through this route of administration.
Commercial Opportunity
PL-3994 is being developed for daily subcutaneous self-administration by heart failure patients to decrease re-hospitalization rates for heart failure. Heart failure affects over 5.7 million people in the United States, with 670,000 new cases diagnosed each year. Despite the treatment of heart failure with multiple drugs, the prognosis remains poor. There were over 1.1 million hospitalizations for heart failure in 2006 in the United States, with projected direct and indirect costs of heart failure in the United States for 2009 of $37.2 billion.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin Technologies' website at www.palatin.com.
Forward-looking Statements
Statements about future expectations of Palatin Technologies, Inc., including statements about its development programs, proposed indications for its product candidates, clinical activities, marketing collaborations, and all other statements in this document other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Palatin's actual results may differ materially from those discussed in the forward-looking statements for various reasons, including, but not limited to Palatin's ability to fund development of its technology, ability to establish and successfully complete clinical trials and pre-clinical studies and the results of those trials and studies, dependence on its partners for certain development activities, need for regulatory approvals and commercial acceptance of its products, ability to protect its intellectual property, and other factors discussed in the Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
-- 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.
SOURCE Palatin Technologies, Inc.
