AEterna Zentaris' North American Partner Announces Disclosure of Phase II results with Perifosine in prostate cancer at the Amer
May 16 2005 - 2:40PM
PR Newswire (US)
AEterna Zentaris' North American Partner Announces Disclosure of
Phase II results with Perifosine in prostate cancer at the American
Society of Clinical Oncology Annual (ASCO) Meeting Further Evidence
of Single Agent Activity Observed QUEBEC CITY, May 16
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announced that its North American partner for perifosine,
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) disclosed earlier
today that data presented at the annual meeting of the American
Society of Clinical Oncology (ASCO) in Orlando, Florida,
demonstrated the tolerability and potential efficacy of perifosine
in the treatment of patients with biochemically recurrent
hormone-sensitive prostate cancer (HSPC). This study was conducted
by a consortium of cancer centers under the leadership of the
University of California, Davis pursuant to a Collaborative
Research and Development Agreement (CRADA) between Keryx and the
National Cancer Institute. Perifosine is a novel, oral, anticancer
agent that modulates AKT and several other important signal
transduction pathways, including MAP kinase and JNK. This
single-agent Phase II multi-center study of perifosine enrolled 25
patients with HSPC who had received prior prostatectomy and/or
radiation treatment and had a rising PSA without radiographic
metastasis. In the study, the patients received a loading dose of
perifosine of 900mg on day one, in divided doses of at least six
hours apart, then 100mg daily. Of the 25 patients enrolled, 22 were
evaluable for response. Of the evaluable patients, 18 patients
(82%) had stable disease and 3 (14%) had PSA progression. While no
patients had a greater than 50% reduction in PSA, 3 patients (14%)
had a minor response demonstrated by a PSA reduction of less than
50%. Grade 3-4 toxicities included grade 3 hyponatremia, arthritis,
hyperuricemia and vision change. The authors concluded that
perifosine in HSPC patients is feasible, well- tolerated and can
reduce PSA by less than 50% in some patients. Because of its
inhibitory effects on the P13K/AKT pathway, further studies of
perifosine in combination with androgen ablation and chemotherapy
are warranted. Michael S. Weiss, Chairman and Chief Executive
Officer of Keryx, stated, "We are very pleased with the results of
this study. These data provide additional evidence of perifosine's
potential anti-cancer activity and provide a strong basis for
further studies in prostate cancer, which we plan to initiate this
year. Our goal remains to provide data from our corporate sponsored
clinical program later this year or early next year that will lead
us to one or more regulatory approval pathways." "We are
appreciative of Keryx's strong commitment to pursue further
clinical trials with perifosine following these encouraging data.
Later this year, we will initiate our own Phase II clinical trials
of perifosine in combination with radiotherapy, as part of our
comprehensive development program for this product," said Prof.
Jurgen Engel, Executive Vice President, Global R&D and Chief
Operating Officer at AEterna Zentaris. To access the abstract,
entitled "The AKT Inhibitor Perifosine in Biochemically Recurrent
Prostate Cancer (HSPC): A Phase 2 California Cancer Consortium
Trial" please click on http://www.keryx.com/pr/0401abstract.pdf .
Perifosine is out-licensed by AEterna Zentaris to Keryx, which
holds North American rights to the drug. AEterna Zentaris holds the
rest of the world rights. About Perifosine Perifosine, 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. 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
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