Palatin, King start phase 2b clinical trial evaluating PT-141 in sexual arousal disorder patients

By E. Janene Geiss

Philadelphia, Feb. 7 - Palatin Technologies, Inc. and King Pharmaceuticals, Inc. said Tuesday that the companies have started enrollment in a double-blind, placebo-controlled phase 2b clinical trial of PT-141 in patients with female sexual arousal disorder.

The primary objective of this pilot clinical trial is to evaluate the safety and efficacy of PT-141 in patients in the "at-home" environment, according to a company news release.

This phase 2b clinical trial is designed to enroll about 60 women with a confirmed diagnosis of female sexual arousal disorder.

The clinical trial entails a two-month treatment period and will be conducted at about 10 clinical trial sites throughout the United States, officials said.

"Together with our colleagues at King, we are very excited to commence this important, initial exploratory trial to evaluate PT-141 in female sexual arousal disorder patients in the 'at-home' environment. The data we gather from this study should prove significant for purposes of determining the future course of development for PT-141 in the treatment of female sexual dysfunction," Trevor Hallam, executive vice president of research and development of Palatin, said in the release.

The companies expect this phase 2b clinical trial to conclude in the second half of 2006, officials said.

PT-141 is the first compound in a new drug class called melanocortin receptor agonists under development to treat sexual dysfunction.

Palatin is a Cranbury, N.J., biopharmaceutical company primarily engaged in the development of melanocortin-based therapeutics. The company's internal research and development programs, anchored by its proprietary Midas technology, have provided product candidates for the treatment of sexual dysfunction, obesity, congestive heart failure, cachexia and diagnosis of sites of infection.

King, based in Bristol, Tenn., is a pharmaceutical company that capitalizes on opportunities in the industry through in-licensing arrangements and acquisitions of branded pharmaceutical products.

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