CRANBURY, N.J., March 10 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN - News) 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 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.
Preclinical studies have demonstrated that PL-3994 is highly potent and achieves its long duration of action through diminished affinity for a natural clearance mechanism, the body’s natriuretic peptide clearance receptor, and increased resistance to an enzyme naturally found in the body, neutral endopeptidase. In animal models, PL-3994 was able to induce diuresis with a limited decrease in blood pressure, with these effects mediated through stimulation of production of cGMP. PL-3994 is well absorbed by the subcutaneous route of administration.
About Congestive Heart Failure (CHF)
Currently in the U.S., CHF affects nearly 5 million people with 550,000 new cases of CHF diagnosed each year. Despite the treatment of CHF with multiple drugs, almost all CHF patients will experience at least one episode of acute CHF that requires treatment with intravenous medications in the hospital. There were over 1,100,000 hospitalizations for CHF in 2004. Congestive heart failure has tremendous human and financial costs. Estimated direct costs in the U.S. for CHF were $29.6 billion in 2006.
About Acute Systemic Hypertension
An acute elevation of blood pressure, or acute hypertension, is a life- threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. It occurs in nearly 50 percent of patients presenting to the hospital with acute heart failure and is a common occurrence for patients with renal dysfunction. It is critical to rapidly manage and maintain optimal blood pressure to minimize risk of death and damage to vital organs. Of the over 35 million people in the United States with hypertension, over one million people each year will have one or more acute episodes of high blood pressure, requiring treatment in an acute care setting. Acute systemic hypertension has significant risks of cardiovascular injury, including heart attack, stroke, and related injuries.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. The Company’s internal research and development capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling product development. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. The Company currently has collaborations with AstraZeneca and the Mallinckrodt division of Covidien. For additional information regarding Palatin, please visit Palatin Technologies’ website at http://www.palatin.com.
Statements about the Company’s future expectations, including statements about its development programs, the significance of the results of clinical trials, the conduct of future clinical trials, proposed indications for its product candidates, pre-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 and Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements shall 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, the Company’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 recommence marketing and gain commercial acceptance of NeutroSpec®, ability to protect its intellectual property, and other factors discussed in the Company’s annual report on Form 10-K for the year ended June 30, 2007, Forms 10-Q for the quarters ended September 30 and December 31, 2007, and other periodic filings with the Securities and Exchange Commission. The Company is not responsible for updating for events that occur after the date of this press release.
Source: Palatin Technologies, Inc.
