Aeterna Zentaris Inc.
) recently received a setback when an independent Data Safety
Monitoring Board (DSMB) recommended the discontinuation of a
phase III study on its oncology candidate perifosine. The study
was evaluating the efficacy and safety of perifosine in
Takeda Pharmaceutical Company Limited's
) Velcade (bortezomib) and dexamethasone versus placebo in
relapsed or relapsed/refractory multiple myeloma patients.
The independent DSMB recommended the discontinuation of the
phase III study as there was very little chance of the study
meeting its primary endpoint and achieving significant
progression free survival. However, the DSMB did not raise any
safety concerns related to the use of perifosine
Perifosine enjoys an orphan drug designation in both the US
and the EU for the treatment of multiple myeloma. The US Food and
Drug Administration has also granted the candidate a fast track
Perifosine is also being evaluated for multiple oncology
indications including renal cell carcinoma (phase II), non-small
cell lung cancer (phase II), breast cancer (phase II) and
neuroblastoma (phase I).
We note that the discontinuation of the phase III study
evaluating perifosine for relapsed or relapsed/refractory
multiple myeloma is a huge disappointment for Aeterna Zentaris.
The study was being conducted under FDA's Special Protocol
Assessment program. Aeterna Zentaris had planned regulatory
submission based on the potential data from the study.
Aeterna Zentaris currently carries a Zacks Rank #3 (Hold).
Stocks that currently look attractive in the pharma space include
Osiris Therapeutics, Inc.
) with a Zacks Rank #1 (Strong Buy).
AETERNA ZENTARS (AEZS): Free Stock Analysis
CYTOKINETCS INC (CYTK): Free Stock Analysis
OSIRIS THERAPTC (OSIR): Free Stock Analysis
TAKEDA PHARMACT (TKPYY): Get Free Report
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