CRANBURY, N.J., May 20 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced today that dosing has been initiated in a Phase 2a clinical study of PL-3994, a novel, long-acting natriuretic peptide receptor A agonist, in subjects with controlled hypertension.
The study is placebo-controlled and double-blinded, and will include up to five cohorts receiving escalating doses. As many as 35 subjects will be included, with six active subjects and one placebo subject per dose cohort. Subjects passing screening are admitted to a research clinic, placed on a controlled diet and have baseline blood pressures and laboratory values monitored for 24 hours. The next morning, subjects receive a single dose of PL-3994 or placebo with blood pressures and laboratory values monitored for 24 hours. Every other week, another cohort of subjects will receive a higher dose of PL-3994 until a pre-specified blood pressure decrease is observed.
"We are excited with our PL-3994 program's rapid progress. Data from these hypertensive patients will provide key indications of the compound's therapeutic potential," stated Dr. Trevor Hallam, Palatin's Executive Vice President for Research and Development. "We look forward to the completion of this study as well as the reporting of results next quarter."
Based on the results of this study and the previously completed Phase 1 trial in healthy, non-hypertensive volunteers, a Phase 2 trial in patients with episodes of hypertensive urgency is planned for later this calendar year. Palatin is also developing PL-3994 for the treatment of acute decompensated congestive heart failure and plans to initiate a separate Phase 2 study in these patients later this calendar year.
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.
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 Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company primarily focused on discovering and developing targeted, receptor-specific peptide and small molecule therapeutics, including melanocortin ("MC")-based therapeutics. Therapeutics affecting the activity of the MC family of receptors may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, cachexia, hemorrhagic shock and inflammation-related diseases. The Company is exploring other receptor-specific therapeutics, including natriuretic peptide receptor A ("NPRA") agonist compounds for use in treatment of acute systemic hypertension, congestive heart failure and other 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, 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 of Palatin Technologies, Inc., +1-609-495-2200, info@palatin.com,
or Institutional Investors and Media, Carney Noensie of Burns McClellan,
+1-212-213-0006, cnoensie@burnsmc.com, for Palatin Technologies, Inc.
Web site: http://www.palatin.com/
