QUEBEC CITY, Oct. 13, 2011 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced that a manuscript entitled "Perifosine Plus Bortezomib
and Dexamethasone in patients with Relapsed/Refractory Multiple
Myeloma Previously Treated with Bortezomib: Results of a
Multicenter Phase 1/2 Trial" reporting Phase 1/2 combination
activity of perifosine in the treatment of advanced multiple
myeloma (MM) patients, was selected for publication in the
October 10, 2011 online edition of
the Journal of Clinical Oncology (JCO). Perifosine, is the
Company's novel, potentially first-in-class, oral anti-cancer drug
that inhibits Akt activation in the phosphoinositide 3-kinase
(PI3K) pathway, which is currently being investigated in metastatic
colorectal cancer, as well as other cancer indications.
The ongoing Phase 3 study in MM is being conducted under a
Special Protocol Assessment (SPA), and Fast Track designation, as
agreed with the Food & Drug Administration (FDA). Perifosine is
currently also in Phase 3 clinical development for refractory
advanced colorectal cancer, also under an SPA and Fast Track
designation. Perifosine has been granted Orphan Drug Status by FDA
and orphan medicinal product designation from the European
Medicines Agency (EMA) in MM, and has received positive Scientific
Advice from the EMA for both the MM and advanced colorectal cancer
programs, with the ongoing Phase 3 trials for these indications
expected to be sufficient for registration in Europe.
In this Phase 1/2 study, perifosine in combination with
bortezomib +/- dexamethasone was evaluated in 84 heavily
pre-treated patients with relapsed or relapsed/refractory MM. All
patients were required to receive prior bortezomib and most were
bortezomib refractory (73%). The combination demonstrated an
overall response rate (ORR) including MR or > of 41% in all
evaluable patients, with stable disease observed in an additional
41% of evaluable patients. The ORR was 65% for bortezomib-relapsed
patients and 32% for patients with bortezomib-refractory disease.
Median progression-free survival (PFS) was 6.4 months, with a
median PFS of 8.8 months in the bortezomib-relapsed population.
Median overall survival (OS).Therapy was generally well-tolerated;
toxicities, including gastrointestinal side-effects and fatigue,
proved manageable. No treatment-related mortality was seen.
The investigators concluded the data reported for both safety
and efficacy in this patient population were encouraging for the
continued study of perifosine.
Data from this study were previously presented at the 2009
American Society of Hematology (ASH) conference.
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/2011/10/04/JCO.2010.33.9788.abstract?sid=d0e30e69-718c-46ae-81bc-367fdc9d9cb7
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 multiple myeloma, colorectal cancer 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 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 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.