AEterna Zentaris Initiates Phase 1 Trial for ZEN-012, a new small molecule oral anti-cancer drug
January 08 2007 - 7:30AM
PR Newswire (US)
IND accepted by FDA QUEBEC, Jan. 8 /PRNewswire-FirstCall/ --
AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the
initiation of the Company's Phase 1 trial with its small molecule
oral anti-cancer drug, ZEN-012, in patients with solid tumors and
lymphoma, after the Company's Investigational New Drug (IND)
application was accepted by the U.S. Food & Drug Administration
(FDA) in late December 2006. This open-label, dose-escalation,
multi-center, intermittent treatment Phase 1 trial is being
conducted in the United States under the supervision of lead
investigator, Daniel D. Von Hoff, MD, Senior Investigator at the
Translational Genomics Research Institute in Phoenix, Arizona. The
trial will include up to 50 patients with advanced solid tumors and
lymphoma who have either failed standard therapy or for whom no
standard therapy exists. Patients will receive a once-a-week, oral
administration of ZEN-012 for three consecutive weeks, followed by
a one-week period without treatment. The cycles are to be repeated
every four weeks based on toxicity and response, for up to four
cycles. The starting dose of ZEN-012 will be 13 mg/week, with
dose-escalation in subsequent cohorts depending on toxicity. Once
the maximum tolerated dose (MTD) is established, up to 12
additional patients will be enrolled at the MTD level to further
evaluate the safety of ZEN-012 at that dose level. Primary
endpoints of the Phase 1 trial will focus on determining the safety
and tolerability of ZEN-012 as well as establishing the recommended
Phase 2 dose and regimen. Secondary endpoints are aimed at
establishing the pharmacokinetics and determining the efficacy
based on standard response criteria. "Preclinical data has shown
that ZEN-012 has favorable safety and toxicity profiles with strong
in vivo activity as well as efficacy in multi-drug resistant tumor
cell lines," said Dr. Jurgen Engel, Executive Vice President,
Global R&D and Chief Operating Officer at AEterna Zentaris.
"With this Phase 1 trial, we hope to show that simultaneous
inhibition of multiple targets may lead to tumor stabilization and
regression. Taking into account the multiple mechanisms of action
witnessed in our pre-clinical programs, we believe this compound
has the potential to be a novel, promising multi-targeted oral
intermittent cancer therapy." Gilles Gagnon, President and Chief
Executive Officer at AEterna Zentaris added, "We are excited about
initiating this trial, since ZEN-012 is part of an internally
developed new class of oral compounds in oncology. Furthermore,
this is a key element of our strategy aimed at establishing a
risk-adverse profile by targeting earlier stage compounds with high
potential for aggressive development, as we continue to build our
solid endocrinology and oncology franchises." About ZEN-012 ZEN-012
is a novel small molecule and the first anti-cancer drug in
development involving two mechanisms of action: tubulin and
topoisomerase II inhibition. ZEN-012 also expresses additional
modes of action such as pro-apoptotic and anti-angiogenic
properties. ZEN-012 has shown potent in vitro anti-proliferative
activity at nanomolar concentrations against human tumor cell lines
of different origin. ZEN-012 is active in tumor cell lines which
are resistant to cisplatin and doxorubicin as well as to tubulin
inhibitors such as vincristine and paclitaxel. Furthermore, it was
shown that ZEN-012 is a catalytic inhibitor of the enzyme
topoisomerase II with the same potency as amsacrine. Given orally
once or twice weekly, ZEN-012 proved to be a potent inhibitor of in
vivo tumor growth in different models including mammary, colon,
skin, lung, renal and leukemic cancers. About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a growing global biopharmaceutical company
focused on endocrine therapy and oncology with proven expertise in
drug discovery, development and commercialization. News releases
and additional information are available at
http://www.aeternazentaris.com/. Forward-Looking Statements This
press release contains forward-looking statements made pursuant to
the safe harbor provisions of the U.S. Securities Litigation Reform
Act of 1995. Forward-looking statements involve known and unknown
risks and uncertainties, which 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 the 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. DATASOURCE: AETERNA
ZENTARIS INC. CONTACT: Jenene Thomas, Senior Director, Investor
Relations & Corporate Communications, (418) 655-6420,
jenene.thomas@ aeternazentaris.com; Paul Burroughs, Media
Relations, (418) 652-8525, ext. 406,
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