Shares in Aeterna Zentaris (NSDQ:AEZS) fell more than -50% this morning after the company said that the Phase III trial of Zoptrex did not meet its primary endpoint in women with locally advanced, recurrent or metastatic endometrial cancer.
The ZoptEC pivotal trial was designed to evaluate the safety and efficacy of a hybrid molecule made up of a synthetic peptide carrier and doxorubicin. Researchers randomized 512 patients to receive either Zoptrex or doxorubicin intravenously every 3 weeks for up to 9 cycles.
Charlestown, South Carolina-based Aeterna said that Zoptrex did not yield a statistically significant increase in the median period of survival compared to doxorubicin.
“The median overall survival period for patients treated with Zoptrex was 10.9 months compared to 10.8 months for patients treated with doxorubicin. This is not a statistically significant, clinically meaningful increase in overall survival and thus the ZoptEC Phase III clinical study did not meet its primary endpoint,” chief scientific officer Dr. Richard Sachse said in prepared remarks. “In addition, Zoptrex generally performed no better than the comparator drug with respect to the secondary efficacy endpoints. For example, the median period of progression-free survival of the patients in the Zoptrex arm of the study was identical to that for patients in the doxorubicin arm. Finally, there was no meaningful difference between the two arms with respect to safety; the number of patients with cardiac disorders was similar – 8 in the Zoptrex arm and 9 in the doxorubicin arm. Therefore, the results of the study are not supportive to pursue regulatory approval.”
AEZS shares were trading at $1.40 apiece this morning, down -58.2%.
“We are very disappointed with the outcome of the ZoptEC Phase III clinical study. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex with respect to any other indications. I would like to thank my colleagues within Aeterna Zentaris and our external team of clinical investigators for their dedication to and contributions on this project,” CEO David Dodd added.
“Our focus has now shifted entirely to filing our new drug application for Macrilen and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen-related efforts. We continue to believe in the potential that Macrilen provides for us to become a focused specialty pharmaceutical company. Our intention is to submit the Macrilen NDA in the 3rd quarter of 2017 and, if the product receives FDA approval, to commercially launch the product in the 1st quarter of 2018.”