FAIRFIELD, Conn., June 5, 2001 (PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT) announced today that scientists at its exclusive licensee, Palatin Technologies, Inc. (AMEX:PTN), in collaboration with the Oregon Regional Primate Center in Beaverton, Ore., presented today results of preclinical animal efficacy studies of PT-141, Palatin's investigational treatment for male erectile dysfunction (ED). Efficacy was evaluated by PT-141's ability to cause penile erections in both primate and rodent species. Results were presented in abstract form at the annual American Urological Association meeting in Anaheim, Calif. These results, in conjunction with the recent positive Phase I human safety evaluation of PT-141, support PTN's plan to commence Phase II human efficacy trials.
PT-141, a synthetic modification of PT-14, 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, 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. As a result, PTN believes PT-141 has the potential to offer a unique treatment for both male and female sexual dysfunction.
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.
"CTT continues to be encouraged by the progress made by PTN in bringing this treatment to market," said Frank R. McPike, Jr. President and CEO of CTT. "We look forward to the Phase II trials."
PTN said that researchers in the preclinical efficacy studies reported that adult male rhesus monkeys receiving intravenous administration of PT-141 showed a significant increase in the duration and frequency of penile erections from baseline over a two-hour observation period. Similarly when male rats were dosed either intravenously or intranasally, the percentage of rats exhibiting a penile erection, as well as their frequency of penile erections, increased in a dose-responsive manner. No adverse behavioral effects were noted in either the rodent or primate studies.
"These data in non-human primates validate the potential for PT-141 to effectively treat ED in humans. These results, in combination with the positive safety results from our Phase I clinical study, provide the basis for advancing this investigational drug into Phase II efficacy trials later this year," said Annette M. Shadiack, Ph.D., Director of Biological and Pre-clinical Research at PTN.
Palatin recently completed a Phase I safety trial with PT-141 that demonstrated a positive safety profile in humans. PTN reported that PT-141 was well tolerated at all doses, there were no significant changes in blood pressure, heart rate or respiration rate, and investigators reported no serious side effects. PTN plans to initiate a Phase II study in men with ED next quarter, and anticipates initiating a Phase II safety and efficacy study of PT-141 in female patients with sexual dysfunction in the fourth quarter of this calendar year.
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 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, NTRU Cryptosystems, Inc., Palatin Technologies, Inc. and Ribozyme Pharmaceuticals, Inc. Competitive Technologies, Inc. is based in Fairfield, Conn., and has affiliates in Osaka, Japan and London.
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.