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 cyclic guanosine monophosphate levels (cGMP), 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.
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 cGMP, a natural messenger nucleotide.
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 this year. Future plans include the development of PL-3994 for long term administration in patients with chronic CHF. In addition, Palatin plans to develop PL-3994 for the emergency treatment of severe acute systemic hypertension. A Phase IIa study in hypertensive subjects is also planned to start later this year.”