Palatin Technologies Completes Enrollment in Phase 2B Bremelanotide Female Sexual Dysfunction Trial Over 400 Premenopausal Women Enrolled / Data expected 3Q2012
CRANBURY, N.J., March 8, 2012 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced it has completed enrollment in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction (FSD). Over 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, have been enrolled in the study. Patients, who will undergo 16 weeks of treatment, will be randomized to one of four double-blind treatment groups and receive placebo or bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The trial is a multi-centered, placebo-controlled, randomized, parallel-group trial designed to measure the safety and efficacy of subcutaneous (SC) bremelanotide doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide will also be assessed during this trial. The primary efficacy endpoint is the change in the number of satisfying sexual events from baseline to end of study. A number of secondary endpoints will also be examined.
The objectives of the Phase 2B trial are to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 studies. Depending on the results of this trial, Phase 3 studies are anticipated to start in the first half of calendar year 2013.
"We are pleased to have completed patient enrollment on schedule, and remain on target for results from this study in the third calendar quarter of this year," stated Carl Spana, Ph.D., President and CEO of Palatin. "Bremelanotide is the only on-demand treatment for FSD in clinical trials in the United States, and has the potential to transform the treatment of patients with FSD."
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) is a multi-factorial condition that has anatomical, physiological, medical, psychological and social components. FSD includes four disorders: hypoactive sexual desire disorder, female sexual arousal disorder, sexual pain disorder and orgasmic disorder. To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. Approximately 40 million American women are affected by FSD. The National Health and Social Life Survey, a probability sample study of sexual behavior in a demographically representative cohort of United States adults ages 18 to 59, found that approximately 43% of women suffer from some form of FSD, with up to about 15% having associated personal distress required to establish a diagnosis of FSD.
There are no drugs in the United States approved for FSD indications.
Bremelanotide for Sexual Dysfunction
Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women in patients non-responsive to current therapies. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. 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's website at http://www.palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, 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. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
SOURCE Palatin Technologies, Inc.