QUEBEC CITY, March 11, 2013 /CNW Telbec/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") 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."
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects, the successful and timely completion of clinical
studies, the risk that safety and efficacy data from any of our
Phase 3 trials may not coincide with the data analyses from
previously reported Phase 1 and/or Phase 2 clinical trials, the
ability of the Company to take advantage of business opportunities
in the pharmaceutical industry, uncertainties related to the
regulatory process and general changes in economic conditions.
Investors should consult the Company's quarterly and annual filings
with the Canadian and U.S. securities commissions for additional
information on risks and uncertainties relating to forward-looking
statements. Investors are cautioned not to rely on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, unless
required to do so by a governmental authority or by applicable
law.
SOURCE AETERNA ZENTARIS INC.