QUÉBEC CITY, June 18, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that data from two Phase 2
trials in renal cell carcinoma (RCC) for the Company's oral
anticancer drug, perifosine, have been published in the
June 2012 issue of Cancer, a
publication of the American Cancer Society. The article is titled,
"Two Phase 2 Trials of the Novel Akt Inhibitor Perifosine
in Patients with Advanced Renal Cell Carcinoma After Progression on
Vascular Endothelial Growth Factor-Targeted Therapy",
D.C. Cho, T.E. Hutson, W.
Samlowski, P. Sportelli, B. Somer, P. Richards, J.A. Sosman, I. Puzanov, M.D. Michaelson, K.T.
Flaherty, R.A. Figlin and
N.J. Vogelzang. It outlines
perifosine's activity as monotherapy in patients with advanced RCC,
which was comparable to current second-line agents. Both objective
tumor responses and prolonged disease stability were observed, and
perifosine was well tolerated at the 100mg daily dose used in this
trial. Finally, the authors conclude that this compound may be
worthy of further investigation in this indication in combination
with available therapies.
The Studies
Two single-arm, open-label Phase 2 trials (#228 and #231) were
conducted to assess the efficacy and safety of perifosine as
monotherapy in patients with advanced RCC who had failed on
previous vascular endothelial growth factor (VEGF)-targeted
therapy.
In the #228 trial, 24 patients with advanced RCC received oral
perifosine (100 mg daily). The #231 trial enrolled 2 groups that
received daily oral perifosine (100 mg daily): Group A comprised 32
patients who had received no prior mTOR inhibitor, and Group B
comprised 18 patients who had received 1 prior mTOR
inhibitor.
Results
In the #228 trial, 1 patient achieved a partial response and 11
patients had stable disease as their best response. The median
progression-free survival was 14.2 weeks.
In the #231 trial, 5 patients achieved a partial response and 16
patients had stable disease as their best response. The median
progression-free survival was 14 weeks both in patient with and
without prior mTOR inhibitor therapy.
Overall, perifosine was well tolerated, and there were very few
grade 3 and 4 events. The most common toxicities included nausea,
diarrhea, musculoskeletal pain, and fatigue.
Juergen Engel, PhD, President and
CEO of Aeterna Zentaris stated, "These data demonstrate
perifosine's anticancer activity in monotherapy as well as its good
tolerability. The authors' conclusion that perifosine may be worthy
of further studies in combination therapy is in line with the
strategy behind our current Phase 3 trial in multiple myeloma in
which perifosine is combined with bortezomib and
dexamethasone."
About Perifosine
Perifosine is a novel, oral anticancer drug that inhibits Akt
activation in the phosphoinositide 3-kinase (PI3K) pathway. It is
currently in a Phase 3 trial in multiple myeloma for which it has
been granted orphan drug and Fast Track designations by the Food
and Drug Administration, while also having received positive
Scientific Advice and Orphan Medicinal Product designation from the
European Medicines Agency. Furthermore, perifosine is in
earlier-stage clinical development for other cancer indications.
Rights for perifosine have been out licensed to Yakult Honsha Co.
Ltd. for Japan, to Handok
Pharmaceuticals Co. Ltd. for Korea and to Hikma
Pharmaceuticals PLC 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.