Last updated on April 17, 2014 at 17:30 EDT

Aeterna Zentaris: Journal of Clinical Oncology Publishes Phase 2 Clinical Trial Results of Perifosine Plus Capecitabine in Patients with Metastatic Colorectal Cancer

October 5, 2011

Ongoing Phase 3 trial under Special Protocol Assessment and with Fast
Track designation is fully enrolled

QUÓ°BEC CITY, Oct. 5, 2011 /PRNewswire/ – Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the ”Company”), today announced that a manuscript
entitled, “Randomized Placebo-Controlled Phase 2 Trial of Perifosine Plus
Capecitabine as Second- or Third-Line Therapy in Patients with
Metastatic Colorectal Cancer
” reporting Phase 2 activity of perifosine (KRX-0401) in the treatment
of patients with refractory, advanced colorectal cancer (mCRC), was
selected for publication in the October 3, 2011 online edition of the
Journal of Clinical Oncology (JCO). Perifosine, the Company’s Akt/PI3K
inhibitor, is currently being investigated in a Phase 3 trial entitled
the “X-PECT” (Xeloda(®) + Perifosine Evaluation in Colorectal cancer Treatment), which is a randomized (1:1), double-blind trial comparing the
efficacy and safety of perifosine + capecitabine vs. placebo +
capecitabine. In July, the Company announced the completion of
enrolment of the Phase 3 X-PECT study, with approximately 465 patients
in the United States randomized. Approximately 360 events of death will
trigger the un-blinding of the study. Study completion is expected in
Q1 2012.

The JCO publication highlights the efficacy and safety data on the 38
mCRC patients participating in this Phase 2, randomized, multicenter
study, comparing perifosine plus capecitabine (P-CAP) to placebo plus
capecitabine. Based on the data, in which the combination of P-CAP
demonstrated statistical significance with respect to median overall
survival and median time to tumor progression, the investigators
concluded that the P-CAP combination showed promising clinical activity
compared to single-agent capecitabine, and that the difference in
clinical outcome seen with the addition of perifosine was impressive.

Efficacy data from this study was previously presented in June 2010 at
the 46(th) Annual Meeting of the American Society of Clinical Oncology.

A copy of the article featured in the current online edition of the
Journal of Clinical Oncology can be obtained at http://jco.ascopubs.org/content/early/2011/10/03/JCO.2011.36.1980.abstract.

About Perifosine

Perifosine is a novel, oral anticancer treatment that inhibits Akt
activation in the phosphoinositide 3-kinase (PI3K) pathway. The product
works by interfering with membranes of cancer cells thereby inhibiting
Akt signaling which then affects cell death, growth, differentiation
and survival. Perifosine, in combination with chemotherapeutic agents,
is currently being studied for the treatment of colorectal cancer,
multiple myeloma and other cancers, and is the most advanced anticancer
agent of its class. Perifosine, as monotherapy, is being explored in
other indications. The FDA has granted perifosine orphan-drug
designation in multiple myeloma and neuroblastoma, and Fast Track
designations in both multiple myeloma and refractory advanced
colorectal cancer. Additionally, an agreement was reached with the FDA
to conduct the Phase 3 trials in both of these indications under a
Special Protocol Assessment. Perifosine has also been granted orphan
medicinal product designation from the European Medicines Agency (EMA)
in multiple myeloma. Furthermore, perifosine has received positive
Scientific Advice from the EMA for both the multiple myeloma and
advanced colorectal cancer programs, with ongoing Phase 3 trials for
these indications expected to be sufficient for registration in Europe.
Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc.
(NASDAQ: KERX) for North America, to Yakult Honsha for Japan and to
Handok for Korea.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a late-stage oncology drug development company
currently investigating potential treatments for various cancers
including colorectal, multiple myeloma, endometrial, ovarian, prostate
and bladder cancer. The Company’s innovative approach of “personalized
medicine” means tailoring treatments to a patient’s specific condition
and to unmet medical needs. Aeterna Zentaris’ deep pipeline is drawn
from its proprietary discovery unit providing the Company with constant
and long-term access to state-of-the-art therapeutic options. 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