“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 who is the Palatin’s Executive Vice President for Research and Development.
For treatment of acute congestive heart failure, a long-acting natriuretic peptide receptor A is under development. The Phase I trial was a single ascending dose study in 26 healthy volunteers who received the medication or placebo subcutaneously. The trial consists of the evaluations such as safety, tolerability, and pharmaco-kinetics. The evaluations also include several pharmaco-dynamic endpoints that consist of levels of a natural messenger nucleotide, ‘cyclic guanosine monophosphate (CGMP)’.
The primary endpoint of the study that is successfully achieved by the dosing is the reduction in systemic blood pressure. Not even one of the volunteers did experience a serious or adverse effect of the study by receiving a dose of medication. After the single sub-cutaneous dose all of the volunteers were observed for several hours with increase in plasma CGMP levels, increased urination or diuresis and increased sodium excretion or natriuresis. The data analysis is going on and when the analysis is complete, it will be submitted for presentation.
Congestive heart failure is area that needs high medical attention for new therapies. It is the common reason for hospitalization of people in US and occurs in patients older than 65 years of age.
For the treatment of acute congestive heart failure, Palatin is at present developing PL-3994 and also plans to develop it for the emergency treatment of severe acute systemic hypertension. Palatin is planning to initiate Phase II study in both congestive heart failure and hypertensive patients later this year.
According to the pre-clinical studies the PL-3994 is highly potent and acquire it long duration of action through reduced similarity a natural clearance mechanism. The natural clearance mechanism is the body’s natriuretic peptide clearance receptor and increased resistance to an enzyme naturally found in the body i.e. neutral endopeptidase. With a limited decrease in blood pressure Pl-3994 was able to induce diuresis in animal models. These effects are mediated by stimulation of the production of CGMP. The subcutaneous route of administration absorbs PL-3994.
Nearly 5 million people with 550,000 new cases diagnosed each year are affected by congestive heart failure, currently in US. Most of the CHF patients will experience at least one episode of acute CHF that requires hospitalization with intravenous medications even with the treatment of CHF with multiple drugs. Congestive heart failure costs human life as well as financial. $29.6 bullion in 2006 was the estimated direct costs in the US.
A life-threatening condition that causes damage to the brain, heart, kidneys and blood vessels is acute increase in blood pressure or acute hypertension. Acute hypertension can be seen in patients that are hospitalized with acute heart failure as well as common in those with kidney failure. To minimize the risk of death and damage to vital organs it is important to check frequently and maintain optimal blood pressure. The significant risk caused due to acute systemic hypertension is cardiovascular injury such as heart attack, stroke and injuries related to that.
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