AEterna Zentaris: An Interim Report of Toxicity and Response From a US National Cancer Institute Phase III Trial in Lung Cancer
May 17 2005 - 5:07PM
PR Newswire (US)
AEterna Zentaris: An Interim Report of Toxicity and Response From a
US National Cancer Institute Phase III Trial in Lung Cancer with
Neovastat Results Presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting QUEBEC CITY, May 17
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announced that an interim report of toxicity and response
from the ongoing US National Cancer Institute (NCI) Phase III trial
in unresectable stage III non-small cell lung cancer with
Neovastat, was presented earlier today by Dr. Charles Lu, of the
M.D. Anderson Cancer Center, in Houston, Texas and one of the lead
investigators of the trial, at the annual meeting of the American
Society of Clinical Oncology (ASCO) in Orlando, Florida. Data from
341 patients as of November 2004, demonstrated that blinded overall
toxicity observed in this trial appears acceptable. Blinded
response data after induction chemotherapy (IC) and concomitant
chemoradiotherapy (CRT) are available for 233 and 214 subjects,
respectively IC and CRT: partial response and complete response
combined was shown in 35% of IC patients and in 39% of CRT
patients. Stabilization of the disease was observed in 57% of IC
patients and in 48% of CRT patients. Progressive disease was shown
in 8% of IC patients and in 13% of CRT patients. Patients
registered in the trial receive one of two treatment regimens:
carboplatin (C) and paclitaxel (P), followed by concomitant
chemoradiotherapy (CRT) with weekly C and P or cisplatin (CDDP) and
vinorelbine (V) followed by CRT with CDDP and V. Neovastat or
placebo (120ml orally twice daily) is started with induction
chemotherapy (IC) and continued after CRT as maintenance therapy.
The study is being conducted in multiple centers in the United
States and Canada. The planned total number of patients to be
recruited is 756. Accrual to this NCI-sponsored intergroup study
continues and so far, 355 patients have been randomized. The
complete data of the trial is available in the abstract, entitled
"A Phase III study of AE-941 with induction chemotherapy (IC) and
concomitant chemoradiotherapy (CRT) for stage III non-small cell
lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): An
interim report of toxicity and response." About Neovastat Neovastat
is an antiangiogenic inhibitor with multiple mechanisms of action:
inhibition of VEGF signalling, MMP activity, and induction of
endothelial cell apoptosis. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery,
development and marketing. The Company's broad 20 product pipeline
leverages six different therapeutic approaches, including LHRH
antagonists and signal transduction inhibitors. The lead LHRH
antagonist compound, cetrorelix, is currently marketed for in vitro
fertilization under the brand name Cetrotide(R). Cetrorelix is also
in late-stage clinical development for endometriosis and benign
prostatic hyperplasia (BPH). The lead signal transduction inhibitor
compound, perifosine, is a novel, first-in-class, oral anticancer
agent that modulates several key signal transduction pathways,
including AKT, MAPK, and JNK that have been shown to be critical
for the survival of cancer cells. Perifosine has demonstrated
single agent anti-tumor activity in Phase I and Phase II studies
and is currently being studied as a single agent and in combination
with several forms of anti-cancer treatments for various forms of
cancer, including non-small cell lung cancer and breast cancer.
AEterna Zentaris also owns 50.3% of Atrium Biotechnologies Inc.
(TSX: ATB.sv), a leading developer, manufacturer and marketer of
value-added products for the cosmetics, pharmaceutical, chemical
and nutritional industries. News releases and additional
information about AEterna Zentaris are available on its Web site
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. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations: Paul Burroughs, (418) 652-8525 ext. 406,
; Investor Relations: Ginette Vallieres, (418) 652-8525 ext. 265, ;
Europe: Matthias Seeber, +49 69 42602 3425, To request a free copy
of this organization's annual report, please go to
http://www.newswire.ca/ and click on reports@cnw.
Copyright