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news.Aeterna Zentaris has announced the discontinuation of Phase 3 multiple myeloma study of perifosine subsequent to the Data Safety Monitoring Board (DSMB) recommendation.
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According to DSMB, the pre planned interim analysis of efficacy and safety indicates that the study may not reach the significant difference in progression free survival, the primary endpoint.
Aeterna Zentaris president and CEO Juergen Engel said the outcome of the interim analysis reprted by DSMB was disappointing.
"However, we remain focused on other significant opportunities such as our Phase 3 trial in endometrial cancer and Phase 2 trials in breast, prostate and bladder cancer with AEZS-108, our NDA filing for AEZS-130 as an oral diagnostic test for growth hormone deficiency in adults, as well as our earlier-stage oncology compound, AEZS-120," Engel added.
The Phase 3 study was designed to compare the efficacy and safety profile of perifosine against placebo in combination with bortezomib (Velcade) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.