FAIRFIELD, Conn., June 1, 2001 (PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT) today announced that its exclusive licensee, Palatin Technologies, Inc. (AMEX:PTN), yesterday reported positive results from the Phase I clinical safety study of PT-141, its lead investigational drug under study for the treatment of male erectile dysfunction (ED).
PTN stated, the trial, designed as a double-blind, placebo-controlled, dose escalation study, evaluated the safety and pharmacokinetics (absorption of drug and blood plasma level of drug) at various doses and determined the maximum tolerated dose (MTD) in 56 normal volunteers. PT-141 was delivered as a nasal spray. PTN submitted an Investigational New Drug application to begin human studies in December 2000 and began enrollment for the Phase I safety study in February 2001.
PT-141 is a synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha MSH. Investigators in a small pilot study of PT-14 found that the agent was approximately 80 percent effective in treating men with ED. Scientists have determined that receptors for this class of molecules (melanocortin receptors) play a role in several behaviors, some of which include appetite and sexual arousal. Recent findings indicate the effects on sexual function may be stimulated through melanocortin receptors in the brain.
PTN is a CTT exclusive licensee for the underlying technology, developed at the University of Arizona, used in developing PT-14 and PT-141. The National Institute of Health estimates that 30 million men suffer from ED. Revenues generated from any FDA approved Palatin products using CTT technologies will produce royalties for CTT and its client, the University of Arizona.
"This is another encouraging step in bringing this treatment to the market," said Frank R. McPike, Jr., President and CEO of CTT. "CTT looks forward to the Phase II efficacy study results."
According to PTN, participants in the study tolerated treatment well at all dose levels and the MTD was not identified. There were no significant changes in blood pressure, heart rate or respiration rate in treated patients. Investigators reported no serious side effects, including no observations of nausea, vomiting, dizziness, hypotension or syncope (loss of consciousness). Results of the study indicate the rapid appearance (within 5 minutes) of PT-141 in the blood, with maximum levels reached at approximately 30 minutes. In addition, analysis of the preliminary pharmacokinetic results indicates that the nasal formulation should be capable of delivering therapeutic levels of PT-141 in a rapid and consistent manner.
PTN also reported that although efficacy was not a primary end point of the Phase I study, which did not include sexual stimulation, a significant number of erections were observed at one dose level. These preliminary observations will need to be confirmed in upcoming efficacy studies.
Palatin CEO and President Carl Spana, Ph.D., stated, "We are very pleased with the results of this study, which demonstrated a very positive safety profile for PT-141. The study generated significant data relating to the nasal absorption of PT-141 that gives us confidence that nasal delivery of the drug is a very viable commercial option. As a result, we are very excited about advancing the clinical development of PT-141 to a Phase II efficacy trial in patients with ED, which should begin in mid-2001."
Palatin has reported that it believes PT-141 has the potential to offer a unique treatment for both male and female sexual dysfunction. In addition, Palatin plans to conduct a Phase II safety and efficacy study of PT-141 in female patients in the 4th quarter of 2001.
Competitive Technologies' licensee, PTN, located in Princeton, N.J., is a development-stage biopharmaceutical company with products in development using its enabling peptide platform technologies, and proprietary radiolabeled monoclonal antibody.
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 make 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, 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.