QUÉBEC CITY, June 4, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that Johanna Bendell, MD, Director of
Gastrointestinal Cancer Research and Associate Director of Drug
Development at the Sarah Cannon Research Institute in Nashville, Tennessee, presented Phase 3
results for perifosine in refractory colorectal cancer yesterday,
at the American Society of Clinical Oncology (ASCO) Annual Meeting
which is being held in Chicago.
Dr. Bendell was the lead investigator of the trial. Data showed no
benefit in overall survival when adding perifosine to capecitabine
in the refractory colorectal cancer setting, confirming top line
results previously disclosed by the Company on April 2, 2012.
The Study
This was a randomized (1:1), double-blind Phase 3 trial
conducted in the United States by
our former licensee Keryx Biopharmaceuticals, comparing the
efficacy and safety of capecitabine + perifosine (P-CAP) vs
capecitabine + placebo (CAP), involving 468 patients with
metastatic colorectal cancer which was refractory to all standard
therapies. Primary endpoint was overall survival (OS) with
secondary endpoints including overall response-rate (ORR) (complete
(CR) + partial responses (PR)), progression-free survival
(PFS) and safety (clinicaltrials.gov NCT 01002248).
Results
For the total intent to treat (ITT) patient population, median
OS was 6.9 months for the CAP group compared to 6.4 months for the
P-CAP group. Median PFS was 11.4 months for the CAP group compared
to 10.9 months for the P-CAP group. The differences were not
statistically significant. There were 7 complete and partial
responses in the CAP group compared to 6 complete and partial
responses in the P-CAP group.
There was no significant difference in toxicity profiles between
the two arms. The most frequent hematologic adverse event was grade
1/2 anemia (CAP = 30 vs P-CAP = 49). The most non-hematologic
adverse event was grade 1/2 fatigue (CAP = 95 vs P-CAP = 125).
In one pre-defined subgroup to which patients were stratified,
those who expressed the wild-type K-ras proto-oncogene and who had
discontinued oxaliplatin for toxicity rather than for disease
progression, there was a benefit in OS (P-CAP = 8 versus CAP = 6.2
months) and in PFS (P-CAP = 18.6 versus CAP = 6.6 months) for
perifosine treated patients. The reason for this finding is not
clear at present and further analysis, including biomarkers
studies, are ongoing.
Juergen Engel, PhD, President and
CEO at Aeterna Zentaris commented, "These data confirm the
disappointing topline results disclosed in April. However, they do
not deter us from our decision to continue the Phase 3 trial in
multiple myeloma which, as previously stated, was based first and
foremost on existing solid preclinical and clinical data, and on
the support for this drug among key opinion leaders in this field.
Additionally, we believe that market opportunity, examples of other
drugs enjoying success after facing setbacks, as well as the
reasonable investment required to move forward with this study up
to the predefined interim analysis, also make this a sound decision
for the Company. Perifosine in multiple myeloma remains a key
component of our deep pipeline focused on providing novel, targeted
treatment options for cancer patients facing unmet medical
needs."
A copy of the abstract #LBA350 titled, "Results of the X-PECT
study: A Phase 3 randomized double-blind placebo-controlled study
of perifosine plus capecitabine vs. placebo plus capecitabine in
patients with refractory metastatic colorectal cancer", Bendell
JC, Ervin T, Senzer N, Richards D, Firdaus I, Lockhart C, Cohn A,
Saleh M, Sportelli P, Gardner L, Eng C. is available on ASCO's
website at http://chicago2012.asco.org/.
About Perifosine
Perifosine is a novel, oral anticancer compound that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It
works by interfering with membranes of cancer cells, thereby
inhibiting Akt signaling which then affects cell death, growth,
differentiation and survival. Perifosine is currently in a Phase 3
trial in multiple myeloma. In this indication, it has been granted
orphan drug and Fast Track designations by the FDA, as well as
positive Scientific Advice and orphan medicinal product designation
from the EMA. Rights for perifosine have been out licensed to
Yakult Honsha for Japan, to Handok
for Korea and to Hikma Pharmaceuticals for the Middle East and certain countries in
North Africa. Aeterna Zentaris
holds rights for the rest of the world.
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.