Aeterna Zentaris Inc. (AEZS - Free Report) 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 combination with 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 status.
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 companies like Cytokinetics, Inc. (CYTK - Free Report) and Osiris Therapeutics, Inc. with a Zacks Rank #1 (Strong Buy).