PALATIN'S MALE ERECTILE DYSFUNCTION TREATMENT EFFICACIOUS.
Twenty-four patients with mild-to-moderate male erectile dysfunction (MED), who were responsive to currently available oral treatments, were enrolled in this Phase 2A clinical trial. Each patient received placebo and two doses of PT-141 by intranasal administration. Results indicated that PT-141 had a positive effect on both the primary endpoint for the study, duration base rigidity greater than 60% of full base rigidity versus Placebo (P<0.001), and the more rigorous secondary endpoint, duration base rigidity greater than 80% of full base rigidity versus Placebo (P<0.01). Base rigidity of greater than 60% is generally considered sufficient for the commencement of sexual intercourse.
Efficacy was evaluated using RigiScanr, a device that measures penile rigidity and tumescence. PT-141 increased the duration of erectile activity by a factor of 3 times when compared to placebo treatment. The new data demonstrated that average time to onset of the first erection was approximately 30 minutes. These results compare favorably with published results of Rigiscan studies of phosphodiesterase-type 5 (PDE-5) inhibitors. Preliminary results of this Phase 2A trial were previously presented at the American Urological Association (AUA) meeting in May 2002.
"Following our comprehensive analysis of the data, we believe that PT- 141 will command a significant position in the sexual dysfunction market," said Perry Molinoff, MD, Palatin's executive VP of Research and Development. "A profile of PT-141 is emerging that may indicate that PT-141 has better efficacy and safety, particularly cardiovascular safety, than currently available oral treatments. Demonstrating faster time to onset of first erection should offer a distinct advantage relative to currently available oral treatments."
New data was presented on a subset of patients considered to have a more severe form of MED; patients that had no response to visual sexual stimulation (VSS) while taking placebo. In this subset of patients, PT-141 showed a significant effect on both duration of erection with base rigidity greater than 60% (P<0.05) and 80% (P<0.05). In this subset of patients, PT-141 increased the duration of erectile activity by a factor of 12 times when compared to placebo treatment. Based on the strength of this data, Palatin is conducting a Phase 2A study in patients with more severe MED for whom currently available oral treatments do not work. This clinical study has begun enrollment and Palatin expects to complete this study by the end of this calendar year.
"The current results should allow Palatin to position PT-141 as a major competitor in a multi-billion dollar market," commented Carl Spana, Ph.D. president and CEO of Palatin. "Furthermore, the results of our studies offer encouragement to that segment of the population that does not respond to currently available oral treatments for MED. We will be moving PT-141 forward through additional clinical trials as quickly as possible and anticipate beginning at-home Phase 2B trials later this calendar year."
Palatin's research suggests that PT-141 works through stimulation of receptors in the central nervous system (CNS) rather than acting directly on the vascular system. As a result, it may offer significant safety and tolerability benefits over currently available products. The nasal formulation of PT-141 being developed is as convenient as oral treatments and is more patient friendly than invasive treatments for MED, such as injections and trans-urethral pellets and appears to result in a more rapid onset of action than is seen following the oral administration of traditional treatments for MED (i.e., PDE-5 inhibitors).
About Palatin Technologies, Inc.
Palatin Technologies, Inc. (AMEX: PTN) is a biopharmaceutical company engaged in the discovery and development of compounds to treat obesity, sexual dysfunction and inflammation. Based on its proprietary technology, MIDAS(TM), the company aims to design compounds that interact with the melanocortin (MC) family of receptors. MC receptors regulate a diverse array of functions ranging from pigmentation, adrenocortical function, immune modulation, sexual arousal and energy maintenance. The company is currently conducting clinical investigations with its lead drug, PT-141, for the treatment of erectile dysfunction, and is developing additional therapeutic compounds discovered using its enabling peptide platform technology MIDAS. Additionally, Palatin is developing a product for infection imaging, LeuTechr, based on a proprietary radiolabeled monoclonal antibody.
For further information visit http://www.palatin.com or call (609)495-2200.
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|Date:||Nov 1, 2002|
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