CRANBURY, N.J., Sept. 23 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced it presented results from a Phase 1 clinical study with PL-3994, a novel, long-acting natriuretic peptide receptor A (NPRA) agonist under development for treatment of the chronic treatment of heart failure, at the 12th Annual Scientific Meeting of the Heart Failure Association of America at the Metro Toronto Convention Centre, Toronto, Ontario, Canada on September 22, 2008.
The Phase 1 trial was a randomized, double-blind, placebo-controlled, single ascending dose study in 26 healthy volunteers who received the medication or placebo subcutaneously. The objective of the trial was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered PL-3994 in healthy male subjects.
Dosing concluded with the successful achievement of the primary endpoint of the study, a prespecified reduction in systemic blood pressure. PL-3994 produced dose-related decreases in blood pressure, increases in plasma cGMP, and increases in urine volume and sodium excretion. There were no serious or severe adverse events.
The data set presented in poster format is available for viewing on Palatin’s website at http://www.palatin.com.
Palatin completed a positive Phase 2a clinical study with PL-3994 last month in 21 volunteers with controlled hypertension who received the medication or placebo subcutaneously. The results of the study demonstrated that PL-3994 can be given safely to patients taking antihypertensive medications commonly administered to heart failure and hypertension patients.
“We are very excited with the results and progress of our PL-3994 program,” stated Dr. Carl Spana, Palatin’s President and Chief Executive Officer. “A clinical study is targeted to start later this calendar year which will randomize chronic heart failure patients to receive daily subcutaneous injections of PL-3994 in addition to their existing drug regimens. While existing medications are effective in reducing symptoms, reducing the rate of hospitalization and extending life, chronic heart failure patients nonetheless have poor prognoses. Thus, there is clearly a significant medical need for newer agents which can provide further improvement.”
About Heart Failure (HF)
Currently in the U.S., HF affects over 5 million people with 550,000 new cases of HF diagnosed each year. Despite the treatment of HF with multiple drugs, almost all HF patients will experience at least one episode of acute HF that requires treatment with intravenous medications in the hospital. There were over 1.1 million hospitalizations for HF in 2004. Heart failure has tremendous human and financial costs. Estimated direct costs in the U.S. for HF were $29.6 billion in 2006.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company dedicated to the development of proprietary peptide, peptide mimetic and small molecule compounds with a focus on melanocortin and natriuretic peptide receptor systems. The melanocortin system is involved in a large and diverse number of physiologic functions, and therapeutic agents modulating this system may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, ischemia and reperfusion injury, hemorrhagic shock and inflammation-related diseases. The natriuretic peptide receptor system has numerous cardiovascular functions, and therapeutic agents modulating this system may be useful in treatment of heart failure, hypertension and other cardiovascular diseases. 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 http://www.palatin.com.
Forward-looking Statements
Statements about the Company’s future expectations, including statements about its development programs, proposed indications for its product candidates, pre-clinical activities, 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. 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 protect its intellectual property, and other factors discussed in the Company’s 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.
CONTACT: Stephen T. Wills, CPA, MST, EVP-Operations, Chief Financial
Officer of Palatin Technologies, +1-609-495-2200, info@palatin.com; or
Institutional Investors and Media, Susan Kim of Burns McClellan for Palatin
Technologies, Inc., +1-212-213-0006, skim@burnsmc.com
Web site: http://www.palatin.com/
