FAIRFIELD, Conn., Feb. 20, 2002(PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT) reported today that its licensee Palatin Technologies, Inc. (AMEX:PTN) has announced positive results from its most recent Phase 1 clinical safety study of PT-141, PTN's lead investigational drug for the treatment of male and female sexual dysfunction.
Palatin reported that 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.
PTN is a CTT exclusive licensee for the underlying technology, developed at the University of Arizona, used in developing PT-141. Revenues generated from any FDA approved PTN products using CTT technologies will produce royalties for CTT and its client, the University of Arizona.
"The positive results of these studies continue to be encouraging," said Frank R. McPike, Jr., President and CEO of CTT. "PTN is making significant progress in bringing this treatment to the public for both men and women."
According to PTN 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.
PTN reported that 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.
Palatin indicated that 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 Chief Executive Officer 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 the Palatin web site at www.palatin.com.
About Competitive Technologies, Inc.
Competitive Technologies is a global leader in identifying, developing and commercializing innovative life sciences, physical sciences and digital technologies. Competitive Technologies' specialized expertise and experience makes it a valuable partner for inventors, companies and universities of all sizes. CTT has been responsible for closing hundreds of licensing agreements. CTT clients and licensees include: Sony, Matsushita Electric Industrial, the University of Arizona, the University of Colorado, the University of Illinois, Digital Ink, Inc., NTRU Cryptosystems, Inc., Palatin Technologies, Inc. and Ribozyme Pharmaceuticals, Inc. Competitive Technologies, Inc. is based in Fairfield, Connecticut and has affiliates in Osaka, Japan and London, England.
Statements about the Company's future expectations, including development and regulatory plans, and all other statements in this document other than historical facts are "forward-looking statements" within the meaning of applicable Federal Securities Laws and are not guarantees of future performance. These statements involve risks and uncertainties related to market acceptance of and competition for the Company's licensed technologies and other risks and uncertainties inherent in CTT's business, including those set forth in Item 1 of the Company's most recent Form 10-K and other factors that may be described in CTT's filings with the SEC, and are subject to change at any time. The Company's actual results could differ materially from these forward-looking statements. The Company undertakes no obligation to update publicly any forward-looking statement.