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The study is placebo-controlled and double-blinded, and will include up tofive cohorts receiving escalating doses. As many as 35 subjects will beincluded, with six active subjects and one placebo subject per dose cohort.Subjects passing screening are admitted to a research clinic, placed on acontrolled diet and have baseline blood pressures and laboratory valuesmonitored for 24 hours. The next morning, subjects receive a single dose ofPL-3994 or placebo with blood pressures and laboratory values monitored for 24hours. Every other week, another cohort of subjects will receive a higher doseof PL-3994 until a pre-specified blood pressure decrease is observed.
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"We are excited with our PL-3994 program's rapid progress. Data from thesehypertensive patients will provide key indications of the compound'stherapeutic potential," stated Dr. Trevor Hallam, Palatin's Executive VicePresident for Research and Development. "We look forward to the completion ofthis study as well as the reporting of results next quarter."
Based on the results of this study and the previously completed Phase 1trial in healthy, non-hypertensive volunteers, a Phase 2 trial in patientswith episodes of hypertensive urgency is planned for later this calendar year.Palatin is also developing PL-3994 for the treatment of acute decompensatedcongestive heart failure and plans to initiate a separate Phase 2 study inthese patients later this calendar year.
About Acute Systemic Hypertension
An acute elevation of blood pressure, or acute hypertension, is alife-threatening condition that can cause permanent damage to the brain,heart, kidneys and blood vessels. It occurs in nearly 50 percent of patientspresenting to the hospital with acute heart failure and is a common occurrencefor patients with renal dysfunction. It is critical to rapidly manage andmaintain optimal blood pressure to minimize risk of death and damage to vitalorgans. 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 highblood 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 550,000new cases of CHF diagnosed each year. Despite the treatment of CHF withmultiple drugs, almost all CHF patients will experience at least one episodeof acute CHF that requires treatment with intravenous medications in thehospital. There were over 1,100,000 hospitalizations for CHF in 2004.Congestive heart failure has tremendous human and financial costs. Estimateddirect costs in the U.S. for CHF were $29.6 billion in 2006.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company primarilyfocused on discovering and developing targeted, receptor-specific peptide andsmall molecule therapeutics, including melanocortin ("MC")-based therapeutics.Therapeutics affecting the activity of the MC family of receptors may have thepotential to treat a variety of conditions and diseases, including sexualdysfunction, obesity and related disorders, cachexia, hemorrhagic shock andinflammation-related diseases. The Company is exploring otherreceptor-specific therapeutics, including natriuretic peptide receptor A("NPRA") agonist compounds for use in treatment of acute systemichypertension, congestive heart failure and other diseases. Palatin's strategyis to develop products and then form marketing collaborations with industryleaders in order to maximize their commercial potential. The Company currentlyhas collaborations with AstraZeneca and the Ma
