NEW YORK, Oct. 1, 2004 (PRIMEZONE) -- Enhance Biotech (EBOI) is announcing the commencement of recruitment this week of a definitive dose-ranging trial in preparation for Phase III of its premature ejaculation compound LI 301.
The trial is designed to evaluate the efficacy of three doses of LI301 on the Intravaginal Ejaculation Latency Time (IELT) in subjects with premature ejaculation and is being run in association with international clinical development organization Kendle (KNDL). It is based in Europe, will involve in excess of 80 couples and results are expected in the second quarter of 2005. This trial follows on from earlier Phase II work, which gave promising results.
Sam McCormick, Chief Science Officer of Enhance, confirmed the primary objective of the study is to evaluate the relative efficacy of three different doses of LI301 in delaying the Intravaginal Ejaculation Latency Time. He added that the study had been carefully designed with expert clinical input to achieve as objective an assessment as possible in what is clearly a difficult condition to evaluate in the clinical trial setting.
Chris Every, CEO of Enhance said, "We are extremely excited by the opportunity LI301 gives us in this potential blockbuster." "Assuming results from this trial and subsequent Phase III studies run to timetable, we can expect to be one of the only companies in a market, that is potentially larger than the erectile dysfunction market."
About Enhance Biotech
Enhance Biotech Inc., recently merged with Ardent Pharmaceuticals, a world-leader in delta receptor science, is developing a product portfolio focused upon two key areas of drug development; Urology, and Dermatology. Within those two areas, the key conditions are; sexual dysfunctions, including premature ejaculation and male fertility, urinary incontinence and dermatological indications, including periodontal disease, cellulite, anti-aging, Atopic dermatitis and psoriasis. Enhancer's portfolio now combines products internally developed from an extensive library of delta receptor compounds created over the last decade and those that are licensed in at pre-clinical or Phase I stages. The products are being taken through development and approval to market by both internal and virtual development routes achieving the best possible selection of resources and skills or each one. Targeted licensing partnerships for each product are being sought and developed while retaining, where potentially viable, a co-promote relationship with the partner for certain products. For more information on the Company please see the Company's website at http://www.enhancelifesciences.com/ or http://www.ardentpharma.com/.
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Enhance Biotech's compounds under development in particular; the potential failure of Enhance Biotech's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Enhance Biotech' compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Enhance Biotech' business, structure or projections; the development of competing products; uncertainties related to Enhance Biotech' dependence on third parties and partners; and those risks described in the filings with the SEC, all of which are under the Company's prior name Becor Communications, Inc. The Company and Enhance Biotech disclaim any obligation to update these forward-looking statements.