AEterna Zentaris' Partner Spectrum Granted IND from FDA to Conduct Phase I/II Clinical Trial with D-63153 in Hormone-Dependent P
May 31 2005 - 8:31AM
PR Newswire (US)
AEterna Zentaris' Partner Spectrum Granted IND from FDA to Conduct
Phase I/II Clinical Trial with D-63153 in Hormone-Dependent
Prostate Cancer in the United States QUEBEC CITY, May 31
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announced that the U.S. Food and Drug Administration (FDA)
has approved a recently submitted Investigational New Drug
Application (IND) by its North American partner, Spectrum
Pharmaceuticals (NASDAQ:SPPI), for D- 63153, a fourth generation
LHRH (Luteinizing Hormone Releasing Hormone) antagonist
administered as a depot formulation. Spectrum is now in a position
to conduct a Phase I/II trial with D 63153 in hormone-dependent
prostate cancer and, thereby, expand the clinical development of D
63153 to the United States. "We are very encouraged by the
continued progress of D-63153, including this near-term expansion
of clinical development to the U.S., as well as the recently
initiated European Phase II trials with this product in hormone-
dependent prostate cancer and benign prostate hyperplasia," said
Gilles Gagnon, President and Chief Executive Officer of AEterna
Zentaris. "D-63153 is an important element of our strategic
development and we are pleased with the strong commitment by our
new North American partner, Spectrum, to work towards the full
development of this innovative LHRH antagonist compound." About
D-63153 strategic alliance with Spectrum Pharmaceuticals In August
2004, AEterna Zentaris granted to Spectrum Pharmaceuticals an
exclusive license to develop and market D-63153 for all potential
indications in North America (including Canada and Mexico) and
India. AEterna Zentaris received an upfront payment which included
cash and equity of Spectrum, at signature, and is eligible to
receive payments upon achievement of certain development and
regulatory milestones, in addition to royalties on potential net
sales. AEterna Zentaris retains exclusive rights to the rest of the
world and will share with Spectrum upfront and milestone payments,
royalties or profits from potential sales in Japan. About Prostate
Cancer According to American Cancer Society's 2004 Cancer Facts and
Figures, over 230,000 new prostate cancer cases are projected in
the United States in 2005. With an estimated 30,000 deaths,
prostate cancer is the second leading cause of cancer deaths in men
in the U.S. According to Prostate Cancer Foundation, one in six
American men will develop prostate cancer in the course of his
lifetime. 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.
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