AEterna Zentaris Advances AN-152 Targeted Anti-Cancer Agent into Clinical Development
January 18 2005 - 7:32AM
PR Newswire (US)
AEterna Zentaris Advances AN-152 Targeted Anti-Cancer Agent into
Clinical Development QUEBEC CITY, Jan. 18 /PRNewswire-FirstCall/ --
AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the
initiation of a company-sponsored Phase I dose-ranging study for
its targeted anti-cancer agent AN-152, a novel cytotoxic conjugate
which has the potential to selectively and specifically target
certain types of cancer cells that express Luteinizing Hormone
Releasing Hormones (LHRH) receptors (LHRH receptor positive tumors)
and thereby may offer a better safety and efficacy profile as
compared to the cytotoxic agent alone. The Phase I study, which
will be conducted at university clinics in Gottingen and
Frankfurt/Main in Germany, will evaluate the safety (including
maximum tolerated dose and dose-limiting toxicity) and
pharmacokinetics of intravenously-administered AN-152 in patients
with LHRH receptor positive ovarian, endometrial or breast cancer.
A high percentage of these cancers, in addition to
hormone-refractory prostate cancer, are known to be LHRH receptor
positive and, therefore, represent logical initial indications for
AN-152. "The initiation of this study not only marks an important
milestone in the development of AN-152, a novel therapeutic
approach against cancer, but also provides yet another proof of the
extremely successful collaboration between our Company and the
laboratory of Nobel Laureate Dr. Andrew Schally at Tulane
University in New Orleans", said Prof. Jurgen Engel, Executive Vice
President, Global R&D and COO of AEterna Zentaris. AN-152 is a
cytotoxic conjugate that is designed to achieve differential
delivery, or targeting, of the cytotoxic agent to cancer vs. normal
cells. In AN-152, doxorubicin (an FDA-approved cytotoxic agent) is
chemically linked to an LHRH agonist, a modified natural hormone
with affinity for the LHRH receptor. This design allows for the
specific binding and selective uptake of the cytotoxic conjugate by
LHRH receptor positive tumors. Potential benefits of this targeted
approach are several-fold, and include a more favorable safety
profile with lower incidence and severity of side effects, as
normal tissues are spared from toxic effects of doxorubicin.
Doxorubicin use is associated with significant, frequently
treatment-limiting cardiac toxicity. In addition, the targeted
approach may enable treatment of LHRH receptor positive cancers
that have become refractory to doxorubicin given in its
non-targeted form. In preclinical studies conducted to date in
several animal models of LHRH receptor positive human cancer,
AN-152's anti-tumor activity and tolerability were shown to be
superior to that of doxorubicin. As would be expected, AN-152 was
not active or was significantly less active than doxorubicin in
LHRH receptor negative cancer cell lines. AEterna Zentaris has
in-licensed worldwide rights to AN-152 from Tulane University.
AN-152 is the lead compound in a series of cytotoxic conjugates
that are designed to target certain tumor cells expressing
receptors for peptide hormones such as LHRH, bombesin and
somatostatin. About AEterna Zentaris Inc. AEterna Zentaris Inc. is
an oncology and endocrine therapy focused biopharmaceutical company
with proven expertise in drug discovery, development and
commercialization. The Company's broad, renewable product pipeline
leverages five 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), and has
successfully completed a broad Phase II program in endometriosis
and benign prostatic hyperplasia (BPH). The lead signal
transduction inhibitor compound, perifosine, is an orally-active
AKT inhibitor that is in several Phase II trials for multiple
cancers. AEterna Zentaris also owns 61.1% of Atrium Biotechnologies
Inc., an international company that develops, manufactures and
markets added-value active ingredients and specialty chemicals for
the cosmetics, chemical, pharmaceutical and nutritional industries,
as well as health and nutrition products. News releases and
additional information about AEterna Zentaris are available on its
new 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: Dr. Mathias Pietras, +49-6942602-3423, To request a free
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