Aeterna Zentaris Sharing Costs, Profits for Cancer Drug
Aeterna Zentaris will share development costs and profits for its drug candidate AEZS-108 (doxorubicin peptide conjugate) with Ergomed Clinical Research, in return for selecting the contract clinical development organization to conduct an upcoming Phase III trial for the endometrial cancer treatment.
Ergomed will assume 30%—up to $10 million—of the clinical and regulatory costs for the Phase III trial with AEZS-108 in endometrial cancer, which are estimated at approximately $30 million over the course of the study. Ergomed has agreed in return to an undisclosed single-digit percentage of any net income received by Aeterna Zentaris for AEZS-108 in the endometrial cancer indication, up to a specified maximum.
“This agreement is part of our nondilutive strategy aimed at minimizing R&D costs while maximizing drug development efficiency,” Juergen Engel, Ph.D., Aeterna Zentaris’ president and CEO, said in a statement.
Aeterna Zentaris envisions marketing AEZS-108 for several additional cancer indications. One of them is ovarian cancer, for which the drug candidate was given an orphan drug designation by FDA and an orphan medicinal product designation from the European Medicines Agency. AEZS-108 is also being investigated in Phase II trials for triple-negative breast cancer, prostate cancer, and bladder cancer.
AEZS-108 is a hybrid molecule composed of a synthetic peptide carrier and the chemotherapy agent doxorubicin. The Phase III trial will compare AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent, or metastatic endometrial cancer. The primary efficacy endpoint will be improvement in median overall survival.
About 500 patients are expected to participate in the Phase III trial, which be an open-label, randomized, multicenter study to be conducted under a Special Protocol Assessment in North America, Europe, Israel, and other countries. The study is not yet recruiting patients, according to a Clinicaltrials.gov page last updated January 11. At the time, Aeterna Zentaris estimated the study would collect final data for the primary outcome measure in December 2015, and be completed a month later.
In Phase II results presented last November at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Berlin, AEZS-108 saw an overall response rate of 30.8%, and a clinical benefit rate of 74.4%. While the overall survival after single agent AEZS-108 was similar to that reported for modern triple-combination chemotherapy, it was achieved with lower toxicity, according to Aeterna Zentaris. Median time to progression was seven months (30 weeks), while overall survival was 14.3 months (62 weeks).
Aeterna Zentaris is a Canadian-based oncology and endocrinology drug developer that markets Cetrotide® (cetrorelix acetate), the first LHRH antagonist treatment approved for in vitro fertilization.
The agreement with Aeterna Zentaris marks Ergomed’s fifth co-development and profit sharing deal signed to date, the company’s CEO Miroslav Reljanovic, M.D., said in the statement.