CRANBURY, N.J., June 24 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of patient dosing and database lock in a double-blind, placebo-controlled, multiple dose, crossover study of bremelanotide, its subcutaneously administered melanocortin agonist for treatment of erectile dysfunction (ED). Palatin expects to report top-line data in the next calendar quarter.
The endpoints in the study are evaluation of plasma exposure and blood pressure, at rest and under exercise stress, in men between 45 and 65 years old, the target demographic. A total of 49 subjects were dosed in the study.
"The current study was designed to provide sufficient confidence in the new route of administration to support further development. We are excited to have completed this safety study and look forward to evaluating this opportunity to bring benefit to patients with erectile dysfunction who do not respond to approved oral therapies," stated Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin.
Based on Palatin's internal review of the data and guidance from an external cardiovascular clinical advisory panel, Palatin intends to submit protocol proposals to Food and Drug Administration for Phase 2, at-home studies of subcutaneous bremelanotide in men with erectile dysfunction who are not responsive to phosphodiesterase-5 inhibitors such as Viagra®, a brand of sildenafil citrate. Phase 2 bremelanotide studies, designed to provide the data required to initiate Phase 3 registration studies, are planned to start as early as the 4th quarter of this calendar year.
"We are excited by the significant commercial opportunity for bremelanotide. About 35% of patients with ED do not respond to approved oral therapies, and with limited treatment options these patients are ideal candidates for subcutaneous bremelanotide," stated Carl Spana, Ph.D., President and CEO of Palatin. "Plus, we have an additional opportunity with female sexual dysfunction (FSD), which represents a large market opportunity with no FDA approved drugs."
About Erectile Dysfunction (ED)
Erectile Dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It is estimated that some degree of erectile dysfunction affects half of all men over the age of 40 and that 150 million men worldwide suffer from erectile dysfunction. Up to 35% of men with erectile dysfunction are non-responsive to standard therapies with phosphodiesterase-5 inhibitors.
About Female Sexual Dysfunction (FSD)
FSD includes four disorders: hypoactive sexual desire disorder, female sexual arousal disorder, dyspareunia and anorgasmia. To establish a diagnosis of FSD, these syndromes must be associated with personal distress, as determined by the affected woman. A February 10, 1999 study published in the Journal of the American Medical Association and titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that approximately 43% of postmenopausal women suffer from some form of FSD. There are no drugs in the United States approved for FSD indications.
Bremelanotide, a synthetic peptide developed and solely owned by Palatin, is believed to act through activation of melanocortin receptors in the central nervous system. Nasal formulations of bremelanotide have been extensively studied, including Phase 2B studies for erectile dysfunction in both non-diabetic and diabetic patients and Phase 2A studies for female sexual dysfunction in both pre- and post-menopausal women. Increases in blood pressure observed in some patients receiving nasally administered bremelanotide, coupled with significant variation in plasma levels, lead to discontinuation of nasally administered bremelanotide as a first-line therapy for sexual dysfunction. Palatin is developing subcutaneous bremelanotide as a therapeutic for treatment of men with erectile dysfunction who are non-responsive to standard therapies with phosphodiesterase-5 inhibitors and for treatment of women with female sexual dysfunction.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonists with a focus on melanocortin and natriuretic peptide receptor systems. Palatin's internally developed drug pipeline utilizes proprietary approaches to discover potent rigid conformers from flexible peptide starting points. 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.