PALATIN REPORTS POSITIVE PT-141 PHASE 1 CLINICAL RESULTS.
The double-blind, placebo-controlled study evaluated escalating doses of PT-141 in 88 healthy male subjects. Study objectives were to define the maximum tolerated dose (MTD) and investigate the safety and pharmacokinetics (absorption of drug and blood plasma level of drug) of both intranasally and subcutaneously administered PT-141. The investigators also measured the pharmacodynamic effect (efficacy) of PT-141 using the RigiScan(R) Plus System, which assesses the rigidity and tumescence (engorgement) of the penis.
The primary endpoints of the studies were the safety, tolerability, and pharmacokinetic (PK) profile of PT-141. Participants in the studies tolerated treatment well over a broad range of doses, including multiple effective dose levels, following both intranasal and subcutaneous dosing. No significant changes in blood pressure, heart rate or electrocardiogram (EKG) evaluations occurred in response to the drug, and there were no nasal mucosa changes in subjects administered intranasal PT-141. Investigators reported that neither dosage form of PT-141 had any serious side effects. The MTD (vomiting by some subjects) could only be reached during the subcutaneous dosing of PT-141.
Results of the study indicate the rapid appearance (within 5 minutes) of intranasally administered PT-141 in the blood, with maximum levels reached at approximately 30 minutes. Analysis of the preliminary PK results indicates that therapeutic levels of PT-141 are achieved in a rapid and consistent manner following nasal administration.
The secondary endpoint of the study was the presence, duration and rigidity of erections as assessed using the RigiScan(R) Plus System. Based on this measurement, subjects who received PT-141 at effective dose levels had erections more than sufficient for sexual intercourse (as defined by RigiScan(R) score) for a duration of more than one hour, relative to placebo. Erections occurred and were prolonged at doses well below the MTD. Furthermore, the study clearly demonstrated a significant correlation between erectile activity and blood levels of PT-141. These preliminary observations and results will need to be confirmed in the ongoing Phase 2 efficacy studies.
Palatin executive vice president of Research and Development Perry B. Molinoff, M.D. said, "Previous clinical studies with a compound related to PT-141 showed a statistically significant effect in causing erections in patients with erectile dysfunction. In our present studies, we demonstrated that PT-141 could induce robust erections in a dose-dependent manner. Blood levels of drug that were associated with erections were readily achievable following its intranasal administration. The magnitude and consistency of the response make us optimistic that PT-141 will be an effective treatment for patients suffering from erectile dysfunction."
Palatin CEO and president, Carl Spana, Ph.D., stated, "We are pleased with the results of this study, which demonstrated a positive safety profile for PT-141. It also generated meaningful data relating to nasal absorption of PT-141 that gives us confidence that nasal delivery of the drug is a viable commercial option. Moreover, the objective RigiScan(R) measurements of efficacy reported by the investigators at this stage of PT-141's development indicate a clear and significant dose response when compared with placebo. As a result, we are excited about our ongoing Phase 2 efficacy trials in patients with erectile dysfunction, which we anticipate will conclude in the second quarter of calendar year 2002."
PT-141 is a peptide analog of (alpha)-MSH (alpha)-melanocyte-stimulating hormone). Scientists have determined that receptors for this class of molecules (melanocortin receptors) play a role in several behaviors, including sexual arousal and appetite. Recent findings indicate the effects on sexual function may be stimulated through melanocortin receptors in the brain. As a result, Palatin believes PT-141 has the potential to offer a unique treatment for both male and female sexual dysfunction. The company plans to conduct a Phase 2 safety and efficacy study of PT-141 in female subjects beginning in the second quarter of calendar year 2002.
Palatin Technologies, Inc. is a development-stage biopharmaceutical company. 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(TM). Additionally, Palatin is developing a product for infection imaging, LeuTech(R), based on a proprietary radiolabeled monoclonal antibody.
For further information, visit http://www.palatin.com or call 732/225-3883.
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|Comment:||PALATIN REPORTS POSITIVE PT-141 PHASE 1 CLINICAL RESULTS.|
|Date:||Apr 1, 2002|
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