QUEBEC CITY, May 12 /PRNewswire-FirstCall/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug
development company specialized in oncology and endocrine therapy,
today announced that the U.S. Food and Drug Administration (FDA)
has approved the Company's Investigational New Drug (IND)
application for its doxorubicin targeted conjugate compound,
AEZS-108, in luteinizing hormone releasing hormone (LHRH) receptor
positive urothelial (bladder) cancer. Following this approval from
the FDA, the Company expects to initiate a Phase 2 clinical trial
in this indication in the second half of this year.
The study will be conducted at the Sylvester Comprehensive
Cancer Center at the University of
Miami Miller School of Medicine with Gustavo Fernandez, M.D., Assistant Professor of
Medicine, as the Principal Investigator, and will include up to 64
patients, male and female, with advanced LHRH-receptor positive
urothelial (bladder) cancer. The study will be conducted in two
parts; the first one will be a dose-finding part in up to 12
patients and then, the chosen dose will be studied for its effect
on progression-free survival.
Juergen Engel, Ph.D., President
and CEO of Aeterna Zentaris stated, "We are very pleased with the
FDA's approval and excited about this Phase 2 trial in bladder
cancer, since it will be our first with AEZS-108 in the United States, and the first one to
include male patients. With this upcoming Phase 2 trial, as well as
the current Phase 2 trial in advanced ovarian and endometrial
cancer conducted in Europe, for
which final results are expected before year-end, AEZS-108 has
become a major component of our oncology portfolio."
AEZS-108 represents a new targeting concept in oncology using a
cytotoxic peptide conjugate which is a hybrid molecule composed of
a synthetic peptide carrier and a well-known cytotoxic agent,
doxorubicin. The design of this product allows for the specific
binding and selective uptake of the cytotoxic conjugate by
LHRH-receptor-positive tumors. The binding of AEZS-108 to cancerous
cells that express these receptors results in its accumulation and
preferential uptake in the malignant tissue.
About Bladder Cancer
According to the National Cancer Institute, bladder cancer is
the sixth most common type of cancer. In 2009, there were 70,980
new cases and 14,330 deaths from bladder cancer in the U.S.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company
specialized in oncology and endocrine therapy. 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 required by a governmental authority or applicable
SOURCE AETERNA ZENTARIS INC.