Last updated on April 17, 2014 at 1:21 EDT

Aeterna Zentaris: Partner Yakult Initiates Phase 1 Trial in Multiple Myeloma with Perifosine in Japan

June 28, 2012

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/m(2), 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: PR Newswire