Aeterna Zentaris Inc. recently enrolled and dosed the first patient in its phase III study on AEZS-108 (zoptarelin doxorubicin) for the treatment of endometrial cancer in women who are not responding to platinum/taxane-based chemotherapy.
We note that AEZS-108 will be evaluated under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) in the phase III trial. The open-label, randomized, multi-center (North America, Europe, Israel and other countries), phase III trial will enroll approximately 500 patients. The primary efficacy endpoint of the trial is significant improvement in median overall survival.
Earlier, in Sep 2011, Aeterna Zentaris had presented encouraging data from a phase II study evaluating the efficacy and safety of AEZS-108 in patients suffering from advanced endometrial cancer at the European Society of Gynecological Oncology.
The candidate demonstrated an overall response rate and a clinical benefit rate of 30.8% and 74.4%, respectively. Median overall survival was 13.7 months, while median time-to-progression was found to be 7 months. AEZS-108 was well tolerated in the trial.
According to the National Cancer Institute, it is estimated that 49,560 new cases and 8,190 death cases of endometrial cancer could be reported in the U.S. in 2013.
Aeterna recently entered into an agreement with Ergomed Clinical Research Ltd. for co-developing AEZS-108 for endometrial cancer.
As per the terms of the agreement, Ergomed will bear 30% (up to $10 million) of the costs (clinical and regulatory) for the recently initiated phase III trial.
In exchange, Aeterna Zentaris will pay Ergomed an agreed single-digit percentage on net income from AEZS-108 sales for the above mentioned indication.
AEZS-108 is also being evaluated for several other indications including ovarian cancer (phase II completed), prostate cancer (phase II), breast cancer (phase II) and bladder cancer (phase II). We note that AEZS-108 has received orphan drug status from the FDA for ovarian cancer. The European Medicines Agency has also granted orphan medicinal product designation to the candidate for ovarian cancer.
Aeterna Zentaris, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). However, biopharma stocks that currently look attractive include Actelion Ltd. (ALIOF) and Medivation, Inc. (MDVN - Analyst Report) with a Zacks Rank #1 (Strong Buy) and Jazz Pharmaceuticals (JAZZ - Analyst Report) with a Zacks Rank #2 (Buy), respectively.