CRANBURY, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced today the completion of a Phase 2a clinical trial of PL-3994, a novel, long-acting natriuretic peptide receptor A (NPRA) agonist under development for treatment of heart failure (HF). The Phase 2a trial was a randomized, double-blind, placebo-controlled, single ascending dose study in 21 volunteers with controlled hypertension who received the medication or placebo subcutaneously. The purpose of the study was to demonstrate that PL-3994 can be given safely to patients taking antihypertensive medications commonly administered to heart failure and hypertension patients. 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 pre-specified reduction in systemic blood pressure. No volunteer experienced a serious or severe adverse event. Elevations in plasma cGMP levels were all observed for several hours after single subcutaneous doses. Additional data analysis is ongoing and will be submitted for presentation when the analysis is complete.
“We are excited to confirm that PL-3994 can be given safely to patients who are taking blood pressure medications,” stated Dr. Trevor Hallam, Palatin’s Executive Vice President for Research and Development. “As we proceed with an additional Phase 2 study later this year, we will focus on the heart failure patients most in need of new therapies.”
The previously announced Phase 1 study demonstrated that PL-3994 can be given safely and leads to a dose-related decrease in blood pressure and increase in cGMP levels, diuresis (kidney excretion of water) and natriuresis (kidney excretion of sodium). The data from this first study has been accepted for presentation at the 12th Annual Scientific Meeting of the Heart Failure Society of America to be held in Toronto, Canada on September 21-24, 2008.
About Heart Failure (HF)
Currently in the U.S., HF affects nearly 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 agonist 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. 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
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 recommence marketing and gain commercial acceptance of NeutroSpec(R), 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, +1-609-495-2200, info@palatin.com, for Palatin Technologies; or
Institutional Investors and Media, Susan Kim of Burns McClellan,
+1-212-213-0006, skim@burnsmc.com, for Palatin Technologies, Inc.
Web site: http://www.palatin.com/
