QUEBEC CITY, June 28, 2012 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced that its Japanese partner Yakult Honsha ("Yakult")
(Tokyo: 2267) has initiated a
Phase 1 trial in multiple myeloma, a form of blood cancer, with
perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who
are sponsoring and conducting this trial in Japan, reported that a first patient has been
treated with perifosine.
This is an open-label, two step Phase 1 trial in which
perifosine is combined with bortezomib (Velcade®) and
dexamethasone in patients with refractory multiple myeloma who had
previously been treated with bortezomib. The trial is expected to
include a total of 18 patients (6 in step 1 and 12 in step 2).
Patients will receive perifosine daily (50 mg, Days 1-21) in
combination with bortezomib (1.3 mg/m2, Days 1, 4, 8 and
11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9, 11 and 12)
according to a three-week cycle (21 days ± 3 days). The primary
endpoint is safety while secondary endpoints include response rate,
progression-free survival, and time to tumor progression.
Juergen Engel, PhD, President and
CEO at Aeterna Zentaris stated, "We would like to thank our partner
Yakult for their close collaboration in initiating this important
Phase 1 trial in multiple myeloma which is necessary at this time
in order to comply with Japan's
specific registration requirements. Perifosine, also currently in a
Phase 3 trial in other parts of the world in multiple myeloma for
which we expect to reach an interim analysis in the first quarter
of next year, remains a key component of our deep pipeline focused
on providing novel, targeted treatment options for cancer patients
facing unmet medical needs".
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It
has been granted orphan drug and orphan medicinal product
designations from both the FDA and EMA for multiple myeloma.
Perifosine has also received Fast Track designation from the FDA
and positive Scientific Advice from the EMA with results from the
Phase 3 trial in multiple myeloma expected to be sufficient for
registration in Europe, as well as
in North America. Perifosine is
also being explored in combination therapy and in monotherapy in
other cancer indications. Aeterna Zentaris holds rights to
perifosine for North America and
Europe, while rights have been
licensed to Yakult Honsha for Japan, to Handok for Korea, and to Hikma
Pharmaceuticals for the MENA (Middle
East and North Africa)
region.
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.