FAIRFIELD, Conn., May 30, 2002 (PRIMEZONE) -- Competitive Technologies, Inc. (AMEX:CTT) announced that its exclusive licensee Palatin Technologies, Inc. (AMEX:PTN), reported that it presented positive initial results from a Phase 2A clinical trial of PT-141, the company's experimental treatment for Male Erectile Dysfunction (MED), at the American Urological Association annual meeting in Orlando, Florida yesterday.
PTN said that PT-141 was shown to be highly significant (p is less than 0.001) for its primary end-point, as measured by duration of erection greater than 60% (generally considered sufficient for intercourse) when compared against a placebo, as well as other end-points. Phase 2A results as well as safety and efficacy results from earlier Phase 1 trials were presented by Perry Molinoff, MD, Palatin's Executive Vice President of Research & Development.
PTN is a CTT exclusive licensee for PT-141, developed at the University of Arizona. Revenues generated from the sale of any FDA approved PTN products using CTT technologies will produce royalties for CTT and its client, the University of Arizona.
"CTT is very encouraged by the continued positive results of these studies," said Frank R. McPike, Jr., President and CEO of CTT. "PTN has succeeded in reaching another important step to bring this treatment to the public for both men and women."
Dr. Molinoff stated: "Our results provide strong evidence that PT-141 has significant efficacy in patients with mild to moderate erectile dysfunction and that it is well tolerated. Based on these encouraging results, and with additional trials, we believe that PT-141 if approved could become a standard of care for patients suffering from MED. In addition, the nasal formulation of PT-141 is as convenient as oral treatments and more patient friendly than invasive treatments for MED, such as injections and trans-urethral pellets."
PTN reported that the Phase 2A study was placebo controlled and enrolled 24 men suffering from mild to moderate erectile dysfunction; the men received either PT-141 or placebo by intranasal administration. Efficacy was evaluated using RigiScan(r), a device that measures penile rigidity and tumescence. The study included subjects whose condition was organic, caused by hypertension or diabetes, as well as subjects with more mild disease presentation, psychogenic, or a mixed cause. Other promising end-points of the study were duration of erection greater than 80%, which showed statistical superiority to placebo (p is less than 0.01), and extent of rigidity and tumescence on drug versus placebo. PT-141 results were statistically significant for these end-points measured and there were no significant adverse events reported.
"We could not have hoped for a better outcome from this study," commented Carl Spana, Ph.D. President and CEO of Palatin. "It is very exciting to be developing a potential therapy to treat a disorder affecting more than 35 million male and 30 million female patients in the U.S. alone. 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 year and commencing pivotal Phase 3 trials in calendar year 2003."
The primary endpoints of the Phase 1 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. No significant changes in blood pressure, heart rate or electrocardiogram evaluations occurred in response to the drug. 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.
PT-141 is a new, nasally administered peptide under development for the treatment of sexual dysfunction. Palatin research suggests that PT-141 works through a mechanism involving the central nervous system rather than directly on the vascular system. As a result, it may offer significant safety and efficacy benefits over currently available products. In addition to the male sexual dysfunction trials, Palatin recently commenced a Phase 1 trial in human female subjects with PT-141.
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, Aerielle Group International, Inc., 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.
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