Company Has Also Requested Scientific Advice on its Phase 3
Program with Perifosine in Refractory Advanced Colorectal
Cancer.
QUEBEC CITY, April 15
/PRNewswire-FirstCall/ - Æterna Zentaris Inc. (NASDAQ: AEZS, TSX:
AEZ) (the "Company"), a late-stage drug development company
specialized in oncology and endocrine therapy, today announced that
it has requested Scientific Advice from the European Medicines
Agency (EMA) to assure the acceptability of the recently initiated
Phase 3 programs for the development of its lead anticancer
compound, perifosine, in its two lead indications, multiple myeloma
and refractory advanced colorectal cancer. Previously, agreement
was reached with the U.S. Food and Drug Administration (FDA) on a
Special Protocol Assessment (SPA) for the pivotal studies in each
of the lead indications, which will be sponsored by Keryx
Biopharmaceuticals Inc., (Keryx), (NASDAQ: KERX), Æterna Zentaris's
licensee for perifosine in North
America.
In multiple myeloma, the SPA-agreed upon Phase 3 study is a
double-blind, placebo-controlled study of perifosine combined with
bortezomib (Velcade(R)) in bortezomib pretreated patients.
Progression-free survival will be the primary efficacy endpoint in
this trial, which will include follow-up for overall survival. The
advice from the EMA indicates that, in principle, the proposed
study is considered sufficient to provide all data necessary to
support a marketing authorization of perifosine in combination with
bortezomib (Velcade(R)). At the relevant time, the actual approved
indication in Europe will have to
take into account the availability of liposomal doxorubicin
(Caelyx(R)), which in the European Union is approved in bortezomib
pretreated patients with multiple myeloma. Further, the EMA has
confirmed that the planned electrocardiogram (ECG) evaluations
included in the Phase 3 study will suffice to assess the cardiac
safety of perifosine. Therefore, the Company does not intend to
initiate any additional study with perifosine in Europe for the multiple myeloma
indication.
Æterna Zentaris has also requested Scientific Advice for the
development of perifosine in refractory advanced colorectal cancer,
where the SPA-agreed upon Phase 3 study is a double-blind
placebo-controlled study comparing the combination of perifosine
and capecitabine (Xeloda(R)) with single-agent capecitabine
(Xeloda(R)). Patients in this study will be intensively pretreated
and will have failed all available treatment options except
capecitabine (Xeloda(R)). Overall survival will be analyzed as the
primary efficacy endpoint. For both indications, safety data from
studies of perifosine in other indications and drug combinations
will be used as supportive information to define the clinical
safety profile of perifosine.
Dr. Juergen Engel, President and
CEO of Æterna Zentaris stated, "We are very pleased with the
outcome of our discussions with the European Medicines Agency so
far. For the development of perifosine in multiple myeloma, we
believe that the planned North American clinical program, which is
sponsored by our partner Keryx, is sufficient to support an
application for marketing authorization in Europe and the rest of the world. We are
looking forward to the outcome of our discussions with the EMA
which is expected during the third quarter of this year, regarding
our development program in colorectal cancer."
About Scientific Advice
Scientific Advice is a procedure offered by the European
Medicines Agency to stakeholders for clarification of questions
arising during development of medicinal products. The scope of
Scientific Advice is limited to scientific issues, i.e. to quality,
non-clinical and clinical aspects of the concerned medicinal
product not yet unequivocally covered by published scientific
guidelines. Scientific Advice focuses on development strategies
rather than pre-evaluation of data to support a Marketing
Authorization Application. Scientific Advice is legally non-binding
and is based on the current scientific knowledge which may be
subject to future changes.
About Perifosine
Perifosine is a novel, potentially first-in-class, oral
anticancer agent that modulates Akt, and a number of other key
signal transduction pathways, including the JNK and MAPK pathways,
all of which are pathways associated with programmed cell death,
cell growth, cell differentiation and cell survival. The effects of
perifosine on Akt are of particular interest because of the
importance of this pathway in the development of most cancers, with
evidence that it is often activated in tumors that are resistant to
other forms of anticancer therapy, and the difficulty encountered
thus far in the discovery of drugs that will inhibit this pathway
without causing excessive toxicity. High levels of activated Akt
(pAkt) are seen frequently in many types of cancer and have been
correlated with poor prognosis.
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a late-stage drug development company
specialized in oncology and endocrine therapy. News releases and
additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties, which 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 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
the 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
except if we are required by a governmental authority or applicable
law.
SOURCE AETERNA ZENTARIS INC.