(Nasdaq: GTXI)GTX, Inc. saw its shares plunge in the after hours session. After the bell today the company announced top line results of the Phase III clinical trial evaluating toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN, a premalignant lesion of the prostate. The company reported that the incidence of prostate cancer was lower in men receiving toremifene 20 mg compared to placebo but was not statistically significantly different.
"We designed the Phase III trial based upon the successful outcome of our Phase IIb clinical trial. Toremifene 20 mg did also reduce prostate cancer in our Phase III study but based on our review of the top line data, there is not a sufficient reduction in cancers compared to placebo over a three year period to demonstrate the statistical significance required for this study," said Dr. Mitchell S. Steiner, CEO of GTX. "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.
The company said the outcome of this study will not affect its partnership with Ipsen, with whom the company is co-developing toremifene 80 mg, a drug that is supposed to reduce fractures in men with prostate cancer who are undergoing androgen deprivation therapy.
Shares of GTX fell 98 cents or more than 32% in the after hours session, closing at $2.04.
