Palatin Technologies, Inc. Reports Positive Results of a Phase I Clinical Study With PL-3994 for the Treatment of Congestive Hea...( CRANBURY N.J. March 10 /- Palatin...)

CRANBURY, N.J., March 10 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN) announced today the completion of a Phase I clinical trial of PL-3994, a novel, long-acting natriuretic peptide receptor A (NPRA) agonist under development for treatment of acute decompensated congestive heart failure (CHF). The Phase I trial was a randomized, double-blind, placebo- controlled, single ascending dose study in 26 healthy volunteers who received the medication or placebo subcutaneously. The evaluations included safety, tolerability, pharmacokinetics and several pharmacodynamic endpoints, including levels of cyclic guanosine monophosphate (cGMP), a natural messenger nucleotide.

Dosing concluded with the successful achievement of the primary endpoint of the study, a prespecified reduction in systemic blood pressure. No volunteer experienced a serious or severe adverse event. Elevations in plasma cGMP levels, increased diuresis (urine excretion) and increased natriuresis (sodium excretion) were all observed for several hours after single sub- cutaneous doses. Data analysis is ongoing and will be submitted for presentation when the analysis is complete.

"We are excited to confirm that PL-3994 has the profile of biological activity in humans that was predicted from animal model data and that it was safe and well tolerated," stated Dr. Trevor Hallam, Palatin's Executive Vice President for Research and Development. "CHF is the single most common cause of hospitalization in the U.S. for patients older than 65 years of age and is an area of high medical need for new therapies."

Palatin is currently developing PL-3994 for the treatment of acute decompensated CHF and plans to initiate a Phase IIa study in these patients later t
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