SPA for Aeterna Zentaris Candidate - Analyst Blog
January 02 2013 - 4:30AM
Zacks
Aeterna Zentaris Inc. (AEZS) 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 run.
Biopharma stocks that currently look more attractive include
companies like Galena Biopharma Inc. (GALE) and
Targacept Inc. (TRGT). Both the companies
carry a Zacks #1 Rank (Strong Buy).
AETERNA ZENTARS (AEZS): Free Stock Analysis Report
GALENA BIOPHARM (GALE): Free Stock Analysis Report
TARGACEPT INC (TRGT): Free Stock Analysis Report
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