Palatin Technologies, Inc. Initiates Enrollment in Phase 2b Trial With Bremelanotide in Women With Female Sexual Dysfunction
CRANBURY, N.J., June 28, 2011 /PRNewswire/ — Palatin Technologies, Inc. (NYSE Amex: PTN) announced today that enrollment of patients has commenced in Palatin’s Phase 2b clinical trial evaluating the efficacy and safety of bremelanotide (previously called PT-141), an on-demand, first-in-class melanocortin agonist being developed for the treatment of female sexual dysfunction (FSD).
The multicenter study is a placebo-controlled, randomized, parallel group, dose-finding trial that will test three dose levels of subcutaneously administered bremelanotide in premenopausal women diagnosed with female sexual arousal disorder (FSAD) and/or hypoactive sexual desire disorder (HSDD).
The study is expected to enroll 400 premenopausal women across 40 sites within the U.S. and Canada, with a target of randomizing 100 patients to each of three treatment arms and a placebo arm. Patients will undergo 16 weeks of treatment.
The objective of the Phase 2b trial is to measure safety and efficacy of subcutaneous doses intended for on-demand, home use. The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSE).
“We are very excited to have begun patient enrollment for the Phase 2b study of bremelanotide, the most advanced on-demand investigational treatment for FSD. Pending successful completion of the trial, the data will be used to support discussions with the FDA prior to initiation of Phase 3 studies,” stated Carl Spana, Ph.D., President & CEO of Palatin. “We believe bremelanotide has the potential to transform the treatment of patients with FSD, an area of significant unmet need.”
Results from this study are anticipated in the second half of calendar year 2012 and will guide the final design of anticipated Phase 3 studies. For more information on the clinical trial, please visit www.clinicaltrials.gov.
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 (HSDD), female sexual arousal disorder (FSAD), 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. 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, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on developing targeted, receptor-specific small molecule and peptide therapeutics. 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 Technologies’ website at 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.