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
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
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
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
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy), respectively.
AETERNA ZENTARS (AEZS): Free Stock Analysis
ACTELION LTD (ALIOF): Get Free Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
To read this article on Zacks.com click here.