CRANBURY, N.J., Feb. 9 /PRNewswire-FirstCall/ — Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of first cohort dosing in a placebo-controlled, multiple dose study of bremelanotide, its experimental treatment for sexual dysfunction. The primary endpoint in this double-blind safety study is evaluation of blood pressure effects of subcutaneous bremelanotide in men between 45 and 65 years old. The study will also evaluate consistency of plasma exposure of bremelanotide given as repeated subcutaneous injections.
Palatin anticipates completing the study in the current calendar quarter, with data analysis completed in the next calendar quarter.
“The current study is designed to validate our hypothesis that increases in blood pressure and gastrointestinal events seen with intranasally administered bremelanotide were primarily related to high intranasal absorption in a subset of patients. The results from this study in the male demographic we are targeting for commercialization, combined with results from our study reported last August, are intended to further address concerns raised by the Food and Drug Administration,” said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin.
Data from this study will be submitted to the Food and Drug Administration. Palatin intends to initiate a Phase 2, at-home, study of subcutaneous bremelanotide in men with erectile dysfunction who are not responsive to therapies with drugs such as Viagra®, a brand of sildenafil citrate, in the second half of this calendar year. The Phase 2 bremelanotide erectile dysfunction program is designed to provide the data required to initiate Phase 3 registration trials.
“The commercial opportunity for bremelanotide is significant with an estimated market of $500 million to $600 million per year. About 35% of patients with erectile dysfunction 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.
About Erectile Dysfunction
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.
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 such as Viagra and for treatment of women with female sexual dysfunction.
Bremelanotide, a synthetic peptide developed and solely owned by Palatin Technologies, 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. In studies to date with subcutaneous administration of bremelanotide variability in plasma exposure has been significantly reduced, with no statistically significant difference in mean changes in blood pressure seen in subjects receiving bremelanotide compared to placebo.
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 about future expectations of Palatin Technologies, Inc., including statements about its development programs, 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, 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. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for various reasons, including, but not limited to Palatin’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 protect its intellectual property, and other factors discussed in the Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating regarding events that occur after the date of this press release.
SOURCE Palatin Technologies, Inc.