Business/Health Editors
PRINCETON, NJ--(BUSINESS WIRE)--June 22, 2000
Palatin Technologies, Inc. (AMEX:PTN) today announced plans to begin the clinical development of its erectile dysfunction drug, PT-141, following a meeting on June 20 with the U.S. Food and Drug Administration
During the meeting, Palatin and the FDA reviewed the preclinical safety data on PT-141 and reached agreement on the design of initial clinical trials. Palatin is developing PT-141 as a nasal spray for the treatment of erectile dysfunction, and anticipates filing an Investigational New Drug (IND) application later this summer. The initial study will evaluate safety, pharmacokinetics and efficacy in 32 men with erectile dysfunction.
Palatin Technologies Chef Operating Officer Charles Putnam said "Over the last 12 months, our scientists have improved the potency and safety profile of this drug 200 fold. With the recent development of an effective nasal delivery system, we have the foundations of a comprehensive IND application and sufficient evidence of safety to support initial clinical trials. Our meeting with the FDA was constructive, and provided useful perspective on appropriate clinical development plans, which will certainly improve the strength and efficiency of our development program."
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 clinical study of PT-14 found that the agent was approximately 80% effective in treating men with erectile dysfunction. The study was led by Hunter Wessels, M.D., Assistant Clinical Professor of Surgery/Urology and Director of Urodyanamics & Sexual Dysfunction at the University of Arizona Health Sciences Center.
According to Carl Spana, Ph.D., Palatin Technologies President and CEO, "The pre-clinical data indicate that PT-141 has the potential to be free of the cardiac side effects found in many of today's treatments for erectile dysfunction. It works by stimulating receptors in the central nervous system, and has proven to be highly potent in animal studies in several species. We are excited to be taking this new compound into the next stage of product development and look forward to starting clinical trials later this year."
Palatin Technologies, Inc is a development-stage medical technology company developing and commercializing pharmaceutical products for diagnostic imaging and therapy based on its proprietary monoclonal antibody radiolabeling and enabling peptide platform technologies. For further information visit the Palatin web site at www.palatin.com.
For investor information, visit the Allen & Caron Inc web site at www.allencaron.com
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 Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.