GTx, Inc. (GTXI) Met with EMA, Will Initiate Several Enobosarm Phase 1s

On February 10, 2014 at 3:30 p.m. Eastern Time, management of GTx, Inc. (Nasdaq: GTXI) will present a company overview at the Bio CEO & Investor Conference in New York City (the “Conference”). At the Conference, GTx management will provide a business update that includes the information set forth below: The Company announced in August 2013 that the POWER1 and POWER2 Phase 3 clinical trials (the “POWER trials”) evaluating enobosarm 3mg for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer (“NSCLC”) failed to meet the co-primary endpoints of lean body mass and physical function assessed by responders analysis as agreed upon by the U.S. Food and Drug Administration (“FDA”). Since enobosarm 3mg demonstrated a statistically significant effect versus placebo on physical function at three months in the POWER1 Phase 3 clinical trial, assessed by continuous variable analysis as pre-specified in the statistical analysis plan for the European Medicines Agency (“EMA”), the Company recently met with representatives from two member countries to the EMA to review and discuss the results of the POWER trials to determine an appropriate path forward for potentially submitting a marketing authorization application (“MAA”) in the European Union (“EU”) for enobosarm 3mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC. Based on input from the two national authorities, the Company is preparing to initiate seven Phase 1 studies and to develop a pediatric investigation plan (“PIP”) necessary for submission of the MAA. The Company currently expects to submit the MAA to the EMA for enobosarm 3mg by the first quarter of 2015, assuming successful completion of the Phase 1 studies and acceptance of the PIP by the EMA’s Pediatric Committee. The Company also plans to meet with FDA later this calendar quarter to discuss an appropriate regulatory path forward in the U.S. for enobosarm 3mg for the prevention and treatment of NSCLC. GTx also will provide an update on its Phase 2, open label study evaluating enobosarm 9mg oral daily for the treatment of estrogen receptor positive and androgen receptor (“AR”) positive metastatic breast cancer in women who have previously responded to hormonal therapy for the treatment of their advanced breast cancer. Nine clinical study sites in the U.S. have fully enrolled the study with 22 postmenopausal women with advanced breast cancer to assess clinical benefit response after six months of enobosarm 9mg treatment, which is defined as either those women receiving treatment who have demonstrated a complete response (disappearance of all targeted lesions), a partial response (at least a 30 percent decrease in the sum of the diameters of the targeted lesions) or stable disease (no disease progression from baseline). The Company will report that enobosarm 9mg continues to be well tolerated by patients in the study, and that the Company expects to meet the pre-specified goal of demonstrating, after six months of treatment, at least three clinical benefit responses in at least 14 patients with AR positive breast cancer. The study is ongoing and data from all patients in the study is expected late in the second quarter of 2014. A simultaneous webcast of the presentation will be accessible from the Company’s website at http://www.gtxinc.com. An archived replay of the presentation will be available on the Company’s website until February 24, 2014.

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