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Pivotal Year


3/7/2008 1:50:49 PM

In late February 2008, GTx/NASDAQ: GTXI released top-line data from its ongoing pivotal Phase III trial evaluating Acapodene for the treatment of side-effects associated with prostate cancer. Once approved, sales could reach $600 million as Acapodene can improve bone mineral density and lower the lipid profile in prostate cancer patients.

Interim analysis of the Phase III trial evaluating Acapodene for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia is tentatively expected to occur in the first quarter of 2008. There is reason for optimism about Acapodene’s ability to prevent prostate cancer, given the intriguing Phase II results which demonstrated that participants treated for a full year with Acapodene had a 48% reduction in the incidence of prostate cancer versus placebo. Positive prostate prevention data could mean blockbuster status for GTx’s Acapodene. The company could file for regulatory approval in the U.S. and Europe (through partner Ipsen) later in 2008.

GTx’s shares went up on the good news, but it shares has drifted back down. We consider 2008 to be a pivotal year for GTx and a lot is riding on Acapodene.

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Information transmitted via BioSpace.com has been provided by publisher, Nadine Wong, of the "Biotech Sage Report" Investment Newsletter and all comments and opinions are solely those of Nadine Wong. Information provided is not guaranteed as to completeness or accuracy by Nadine Wong (the "Biotech Sage Report" publisher), BioSpace, Inc., or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. The security portfolio of the editor of this newsletter, our employees, principals or affiliated companies may, in some instances, include securities and/or options on securities mentioned in each issue. Additional information is available upon request. Information in this publication has been obtained from sources believed to be reliable, but the accuracy, completeness and interpretation are not guaranteed. Opinions expressed are subject to change without notice. The Information and views provided by the "Biotech Sage Report" Newsletter are prepared by Nadine Wong, and in no way reflect the views or efforts of BioSpace, Inc., any of BioSpace's employees or officers. BioSpace, and BioSpace's employees and officers, as well as (www.biotechnav.com) Wong & Wong, Inc, and Wong & Wong Inc.'s employees and officers, in no way accept responsibility for any of the Newsletter's content.

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