QUEBEC CITY, April 22 /CNW Telbec/ - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS), a global biopharmaceutical company focused on endocrine therapy
and oncology, today presented a poster outlining Phase 1 results for its
orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in
patients with advanced solid tumors or lymphoma, which may potentially provide
a new therapeutic approach for the treatment of cancer. The poster was
presented at the American Association for Cancer Research (AACR) Annual
Meeting in Denver, Colorado.
The poster (#5567) entitled, "Phase I dose-escalation, safety, and
pharmacokinetic study on weekly oral AEZS-112, a small molecule anti-cancer
agent in patients with advanced cancer and lymphoma", D.W. Northfelt, reviewed
results of this Phase I study designed to evaluate the safety, tolerability
and pharmacokinetics of ascending doses of AEZS-112 in patients with the
above-mentioned forms of cancer.
In part I, 22 patients (12 men/10 women) were studied on 7 dose levels
ranging from 13 to 800 mg/week. In all, 62 treatment cycles were administered.
In part II, 22 patients (12 men/10 women) were studied on 5-dose levels
ranging from 120 to 600 (=200x3) mg/week. As of April 1, 2009, 62 treatment
cycles were administered (mean 3.2/patient); treatment was ongoing in 8
patients. Stable disease (SD) for more than 12 weeks was observed in 16
patients; 4 more patients were ongoing at less than 12 weeks. Prolonged
courses of SD ranging from 20 to 39+ weeks were observed in 9 patients with
the following primary cancer types: trachea (39+), tongue (30+), thyroid
(29+), prostate and melanoma (28), non-small cell lung cancer (26+), pancreas
and 2x colorectal (20).
Except for one patient with a background of gastrointestinal problems
(GI) who had dose-limiting GI reactions and electrolyte loss at a dose of
200x3mg/week, no clinically relevant drug-related adverse events or changes in
laboratory parameters were observed. AEZS-112 was shown to be metabolically
stable in human plasma. As predicted by pharmacokinetic modelling based on
data from part I of the study, the split-dose scheme leads to a higher Cmax
and trough values after administration of comparable doses.
- AEZS-112 was well tolerated over repeated treatment courses;
- So far, a maximum tolerated dose for weekly dosing has not been
- Prolonged courses of stable disease in both parts of the study are an
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a 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 www.aezsinc.com.
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. 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 except if we are requested by a
governmental authority or applicable law.
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