Aeterna Zentaris Inc.
AEZS today announced that an
independent Data Safety Monitoring Board ("DSMB") has recommended
discontinuing the ongoing Phase 3 study comparing the efficacy and safety of
perifosine to placebo when combined with bortezomib (Velcade(®)) and
dexamethasone in patients with relapsed or relapsed/refractory multiple
myeloma. Based on the outcome of its pre-planned interim analysis of efficacy
and safety, the DSMB recommended that patient enrollment be stopped and the
study discontinued. The DSMB reported that it was highly unlikely the study
would achieve a significant difference in its primary endpoint, progression
free survival; no safety concerns were raised.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "We are
obviously disappointed with the outcome of the interim analysis as reported to
us by the DSMB, both from a patient and Company perspective. 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."
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