Development On Track at GTx

In the coming months, we will hear plenty of updates on GTx's pipeline. GTx expects to hear back on Acapodene by late October. Management expects a timely Food and Drug Administration decision, since the agency has not yet requested an advisory panel and the drug's active ingredient, toremifene, is not a new chemical entity, which gives the agency a wealth of clinical history and safety data. However, toremifene has caused serious heart problems in patients with prolonged QT intervals, so this safety concern could cause concerns for regulators.

GTx also notably revised its clinical trial plan for Acapodene for the prevention of prostate cancer. We think these changes could improve the commercial prospects of the drug. Instead of conducting an event-based efficacy analysis of its Phase III trial, which would report results in the fourth quarter of this year, GTx will conduct a final analysis of complete trial results in the first quarter of 2010. While the firm will forgo a quicker clinical timeline, the primary endpoints will remain the same, and GTx will have a longer time and a larger patient population to show efficacy. If GTx can reduce the incidence of cancer in the high-risk patient population, it will gain an advantage over close competitors like GlaxoSmtihKline's GSK Avodart and Merck's MRK Proscar, which have only shown statistically significant reductions in patients at low to medium risk of prostate cancer. We'll closely monitor the progress of both indications of Acapodene and publish an update when we hear more news.