AEZS Hammered As Endometrial Cancer Study Flops

(RTTNews) - Shares of AEterna Zentaris Inc. (AEZS) (AEZS.TO) are down over 59% in pre-market trading today, following disappointing results from its phase III study of drug candidate Zoptrex in women with locally advanced, recurrent or metastatic endometrial cancer.

The phase III study, dubbed ZoptEC, enrolled over 500 patients, who were centrally randomized in a 1:1 ratio and received either Zoptrex or chemotherapy medication Doxorubicin intravenously, every three weeks and for up to nine cycles.

ZoptEC did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with Doxorubicin.

According to the trial results, the median overall survival period for patients treated with Zoptrex was 10.9 months compared to 10.8 months for patients treated with Doxorubicin, which is not a statistically significant, clinically meaningful increase. In other aspects too, say - progression-free survival and safety - Zoptrex was no better than the comparator drug in the study.

AEterna has decided not to pursue regulatory approval for Zoptrex.

AEZS closed Friday's trading at $3.35. In pre-market trading today, the stock is down 59.70% to $1.35.