Aeterna Zentaris Inc. (NASDAQ:AEZS)
Aeterna Zentaris Inc. (NASDAQ:AEZS) has announced that its ZoptEC Phase 3 clinical trial of Zoptrex™ (zoptarelin doxorubicin), used in women with locally severe metastatic recurrent endometrial cancer, failed to attain its primary endpoint – a statistically significant raise in the average period of overall survival patients administered with Zoptrex™ compared to those on doxorubicin treatment.
Aeterna Zentaris Inc. (NASDAQ:AEZS) Chief Scientific Officer Dr. Richard Sachse in a statement said the product recorded an average overall period of 10.9 months as compared to doxorubicin’s 10.8 months. The figure does not meet the statistically significant clinical threshold required in the overall survival rates and hence the ZoptEC Phase 3 clinical trial failed. Additionally, Aeterna Zentaris Inc. (NASDAQ:AEZS) Zoptrex™ did not show any unique features or advantages compared to existing products in regards to the secondary endpoints of safety and efficacy.
According to Dr. Sachse, the product’s median period for patients’ progression-free survival on the Zoptrex™ trial was similar to that of patients in the doxorubicin study. Finally, the product did not exhibit any significant difference between itself and doxorubicin in regards to safety. Both studies had almost similar number of cardiac disorder patients with the Zoptrex™ having eight and the doxorubicin having nine. It is on these grounds that the results were deemed not strong enough to seek regulatory approval of the product.
The company’s President and Chief Executive Officer David A. Dodd expressed disappointment with the outcome of the study. He added that the company won’t undertake any Zoptrex™ trials in regards to any other indications. He thanked the company’s internal team at Aeterna Zentaris Inc. (NASDAQ:AEZS) as well as the company’s team of external investigators for their professionalism and dedication during the exercise.
In what could be the company’s next plan after the disappointing results, Mr. Dodd said they will be shifting focus towards Macrilen™, a new drug application being developed by the company. He expressed optimism that Macrilen™ will go through the final stage. The company is working to make sure that Macrilen™’s NDA is ready for submission in the third quarter of 2017. If the product if approved by the FDA, it will be launched for commercialization in the first quarter of 2018.
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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.