GTx (NASDAQ: GTXI) reported yesterday afternoon that its prostate cancer prevention drug failed to perform significantly better than a placebo in a late-stage trial, and the news pushed its stock price into a 37 percent dive as one analyst announced that the data signalled "game over" for the cancer indication.
Patients taking toremifene 20 mg had a 10.2 percent lower rate of prostate cancer than the control group, but that wasn't enough to achieve statistical significance. Researchers recruited 1,590 men with high grade premalignant lesions, a warning signal for prostate cancer.
The failure is another big setback for the Memphis-based GTx. Last November the FDA demanded another late-stage trial of toremifene 80 mg if the developer wanted to gain an approval to use the drug to prevent fractures in men with prostate cancer. Ipsen is partnered on the program and they're still planning to push ahead with the new study in order to win an approval. Now GTx researchers will have another new task at hand: figuring out what went wrong in the Phase III cancer prevention study.
"We intend to review all data from the study this summer to better understand the trial results and the ability of toremifene 20 mg to reduce cancer among these high risk men," said GTx CEO Mitchell Steiner.
Rodman & Renshaw's Simos Simeonidis, though, says that the data is "game over" for toremifene 20 mg. "Even if the company or a potential partner decide to have another go at it with another Phase III trial, as they are planning to do with the 80mg dose, we A) don't believe that an additional Phase III has a decent chance of providing a different outcome, and B) the best case scenario is that any such additional trial will read out in another 3-5 years, so it would make no sense to include in the company's current valuation."