Aeterna Zentaris: Phase 2 Data for Perifosine as Monotherapy for Renal Cell Carcinoma Published in June Issue of Cancer
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.
