Aeterna Zentaris Inc.
) recently announced that its oncology candidate, AEZS-108
(doxorubicin peptide conjugate) will be evaluated under US Food
and Drug Administration's (FDA) Special Protocol Assessment (SPA)
in a phase III trial.
The open-label, randomized, multi-center (North America and
Europe) phase III trial will enroll approximately 500 patients.
The trial will evaluate the use of AEZS-108 as second-line
treatment option for locally-advanced, recurrent or metastatic
endometrial cancer versus doxorubicin, a commonly used
chemotherapy drug. The primary efficacy endpoint of the trial is
to find significant improvement in median overall survival.
Earlier, in September 2011, Aeterna Zentaris presented
encouraging data from a phase II study evaluating efficacy and
safety of AEZS-108 in patients suffering from advanced
endometrial cancer. The candidate demonstrated overall response
rate and 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 7 months. AEZS-108 was well
tolerated in the trial.
The candidate 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. European Medicines Agency
has also granted orphan medicinal product designation to the
candidate for ovarian cancer.
We currently have a Neutral recommendation on Aeterna
Zentaris. The stock carries a Zacks #2 Rank (Buy) in the short
Biopharma stocks that currently look more attractive include
Galena Biopharma Inc.
). Both the companies carry a Zacks #1 Rank (Strong Buy).
AETERNA ZENTARS (AEZS): Free Stock Analysis
GALENA BIOPHARM (GALE): Free Stock Analysis
TARGACEPT INC (TRGT): Free Stock Analysis
To read this article on Zacks.com click here.