Shares of GTx/NASDAQ: GTXI are on a roll as investors anticipate the release of top-line data from a Phase II clinical trial on ostarine as a treatment in elderly men and women to ameliorate frailty, muscle wasting and bone loss. Investors should be looking for an improvement in weight gain in the form of increased muscle mass and for an increase in bone mineral density, as well as the difference in clinical response across genders. In addition, investors should look for improvements in lipid profiles and prostate-specific antigen without liver toxicity, hair growth and increased secretions from the sebaceous glands that are typically associated with testosterone administration. With positive data, the trial will advance into Phase IIb/III trials in the first half of 2007. Additional upcoming information includes a positive safety evaluation from the Data Safety Monitoring Board for Acapodene derived from a Phase III clinical study during the first quarter of 2007. So far, interim analysis has demonstrated that men with prostate cancer on androgen deprivation therapy experienced a statistically significant increase in bone mineral density after one year of treatment with 80 mg of Acapodene. Meanwhile, Acapodene is in a pivotal Phase III trial in an 80 mg dose for the treatment of multiple serious side effects of androgen deprivation therapy. After completing the full two years of therapy, prostate cancer patients in the pivotal Phase III will be enrolled in a separate Phase IIIb extension trial for an additional year of therapy. The purpose of this study is to collect additional efficacy and safety data that could further support the current Phase III clinical study. Since this is a separate study it does not affect the current timeline for the completion of the ongoing Phase III clinical trial. Management is still guiding for completion of this study and a potential NDA submission in the second half of 2007.
With anticipated news flow, we believe GTx shares will continue its upward momentum.
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