Data from Perifosine Phase II Single-Agent Soft Tissue Sarcoma Study Presented at the 16th Annual EORTC-NCI-AACR Conference
September 30 2004 - 9:50AM
PR Newswire (US)
Data from Perifosine Phase II Single-Agent Soft Tissue Sarcoma
Study Presented at the 16th Annual EORTC-NCI-AACR Conference
QUEBEC, Sept. 30 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc.
(TSX: AEZ; NASDAQ: AEZS) through its North American partner, Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX), announced today that Phase
II data presented at the 16th Annual EORTC-NCI-AACR symposium on
"Molecular Targets and Cancer Therapeutics" demonstrated the
tolerability and potential efficacy of perifosine in the treatment
of patients with advanced soft tissue sarcoma. This study was
conducted by the National Cancer Institute (NCI) pursuant to a
Collaborative Research and Development Agreement (CRADA) between
Keryx and the NCI. In this single-agent Phase II multi-center study
of perifosine, 23 patients with advanced soft-tissue sarcoma
received a loading dose of 150 mg, every six hours starting on day
one, followed by 100 mg daily thereafter. The patients enrolled in
this study had prior treatment, including 1-2 chemotherapy
regimens, surgery and/or radiotherapy. Nineteen patients received
more than one course of treatment. There was one confirmed partial
response lasting more than five months and two patients that
remained progression-free at six months. Perifosine was also shown
to be well tolerated at the doses used. All 23 patients were
evaluable for toxicity and notable toxicities seen included Grade 4
ileus (one patient), Grade 3 toxicity (six patients) including
fatigue (two patients) and one patient each of anemia, infection,
muscle weakness, pain, rash, anorexia, dehydration, and diarrhea.
Of the Grade 3 and 4 toxicities seen, it is unclear which ones were
related to the disease or the drug. There was no Grade 3 or 4
nausea or vomiting seen in this trial. The authors concluded in
summary that the regimen was tolerable and that the preliminary
observation of another responder in soft tissue sarcoma, such as
was seen in the Phase I program, raises the question of whether
specific histologies or tumor characteristics might predict a more
sensitive subpopulation of soft tissue sarcoma patients. I. Craig
Henderson, M.D., President of Keryx Biopharmaceuticals, commented,
"The level of activity seen in this study, combined with the
previous Phase I single-agent experience where two partial
responses were reported out of ten sarcoma patients enrolled,
provides us with very strong evidence for the potential
single-agent activity of this drug in soft tissue sarcoma,
particularly in one or more subtypes." Dr. Henderson added, "Soft
tissue sarcoma is a very aggressive disease characterized by many
heterogeneous subtypes or histologies, for which few, if any, drugs
work across multiple subtypes. The overall response rate of
sarcomas to the most effective front-line chemotherapy treatments
is about 10-20%, and some subtypes are totally unresponsive to any
form of chemotherapy." Dr. Henderson also stated, "We believe that
our correlative science program will help us to potentially
identify at least one subtype of soft tissue sarcoma for which we
may be able to conduct a single-agent registration trial with
perifosine in the near future." Gilles Gagnon, Chief Executive
Officer and President of AEterna Zentaris, concluded, "We are
pleased with the continued advancement of clinical development of
perifosine by our partner Keryx and their ongoing commitment to
aggressively develop perifosine as a single agent or in combination
with other cancer treatments." To access the abstract, entitled
"Tolerability and limited activity of perifosine in patients with
advanced soft tissue sarcoma (STS): a multi-center phase 2
consortium (P2C) study," please click here. Perifosine is
in-licensed by Keryx from AEterna Zentaris Inc. (TSX: AEZ, Nasdaq:
AEZS), which holds ex-North American rights to the drug. About
AEterna Zentaris Inc. AEterna Zentaris Inc. is a biopharmaceutical
company focused in oncology and endocrine therapy. Its extensive
portfolio, from drug discovery to marketed products, includes
perifosine, an orally-active AKT inhibitor in several Phase II
trials for multiple cancers, and cetrorelix, an LHRH antagonist
already marketed for in vitro fertilization under the brand name
Cetrotide(R), and also in advanced clinical development for the
treatment of uterine myoma, endometriosis and benign prostatic
hyperplasia (BPH). AEterna Zentaris also owns 62% of Atrium
Biotechnologies Inc., which develops, distributes and markets
active ingredients, specialty fine chemicals, cosmetic and
nutritional products for the cosmetics, chemical, pharmaceutical
and nutritional industries. 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, Jacques Raymond, (418) 652-8525 ext. 360, ;
U.S. Investor Relations, Lippert/Heilshorn & Associates, Kim
Golodetz, (212) 838-3777, ; Europe, Matthias Seeber, +49 69 42602
3425,
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