CRANBURY, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of PL-3994, a long acting analog of atrial natriuretic peptide, under development for treatment of acute decompensated congestive heart failure (CHF). The trial is being conducted under an Investigational New Drug application Palatin submitted to the U.S. Food and Drug Administration. Future plans include the development of PL-3994 for long term administration in patients with chronic congestive heart failure.
The Phase 1 trial of PL-3994 is a randomized, double-blind, placebo- controlled, single-ascending dose study in healthy volunteers who will receive the drug subcutaneously. The evaluations will include safety, tolerability, pharmacokinetics and several pharmacodynamic endpoints, including endogenous messenger levels such as cyclic guanosine monophosphate.
Dr. Trevor Hallam, Palatin’s Executive Vice President for Research and Development, stated, “We are excited to begin clinical trials of PL-3994, a compound developed by Palatin scientists that has the potential to become a new tool for physicians to advance the treatment of congestive heart failure. CHF is the single most common cause of hospitalization in the U.S. for patients older than 65 years of age and an underserved medical condition.”
Atrial natriuretic peptide (ANP) is a naturally produced peptide hormone involved in regulation of water and sodium levels in the circulation. Palatin’s PL-3994 is a peptidomimetic compound, which incorporates features of both natural ANP and small molecules.
Preclinical studies have demonstrated that PL-3994 is highly potent. Its longer duration of action is believed to relate to diminished affinity for the natriuretic peptide clearance receptor and increased resistance to the enzyme neutral endopeptidase, both pathways for clearance of endogenous natriuretic peptides. In animal models, PL-3994 was able to induce diuresis (excretion of fluids) with a limited decrease in blood pressure. The compound 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 and 550,000 new cases of CHF will be diagnosed this 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. Congestive heart failure has tremendous human and financial costs. Annual medical expenditures for CHF are estimated to be $28.8 billion.
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(R), 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 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.
CONTACT: Stephen T. Wills, CPA, MST EVP-Operations, Chief, Financial
Officer, Palatin Technologies, +1-609-495-2200, info@palatin.com; or
Investors and Media, Carney Noensie of Burns McClellan, +1-212-213-0006,
cnoensie@burnsmc.com
Web site: http://www.palatin.com/
