Aeterna Zentaris Announces Completion of Patient Enrollment for Multi-Center Phase 2 Trial with Perifosine in Combination with R
November 14 2007 - 7:30AM
PR Newswire (US)
QUEBEC CITY, Nov. 14 /PRNewswire-FirstCall/ -- Aeterna Zentaris
Inc. (NASDAQ:AEZSNASDAQ:TSX:NASDAQ:AEZ), a global biopharmaceutical
company focused on endocrine therapy and oncology, today announced
the completion of patient recruitment for the Company's European
multi-center Phase 2 trial in non-small cell lung cancer (NSCLC)
with its novel, first-in-class, oral signal transduction inhibitor,
perifosine. This randomized, double-blind, placebo-controlled trial
will assess the efficacy and safety of a 150 mg daily dose of
perifosine when combined with radiotherapy in 160 patients with
inoperable Stage III NSCLC. David J. Mazzo, Ph.D., President and
Chief Executive Officer at Aeterna Zentaris said, "We are pleased
to have completed enrollment for our Phase 2 trial with perifosine
in combination with radiotherapy. Patients will be followed for a
one-year period after receiving treatment, and therefore, we expect
to announce top-line results at the end of 2008." About the Phase 2
Trial Patients receive perifosine daily for 5 to 6 weeks, starting
seven days prior to radiotherapy, and are followed for at least 12
months. The primary endpoint of this trial is the extent and
duration of local control, i.e., the absence of tumor recurrence or
progression in the area that has been irradiated. The trial is
being conducted in collaboration with the Netherlands Cancer
Institute. The lead investigator is Marcel Verheij, MD, Ph.D., of
the Department of Radiation Oncology / Division of Cellular
Biochemistry, at The Netherlands Cancer Institute in Amsterdam.
About Perifosine Perifosine is a novel, first-in-class, oral
anti-cancer 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 1 and Phase
2 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. Perifosine is licensed to Keryx
Biopharmaceuticals in the United States, Canada and Mexico. 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 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. 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. DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Jenene
Thomas, Senior Director, Investor Relations & Corporate
Communications, (908) 938-1475, ; Paul Burroughs, Media Relations,
(418) 652-8525 ext. 406,
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