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.
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