AEterna Zentaris Partner Keryx Presents Phase 1 and Phase 2 Results for Anti-Cancer Compound Perifosine at ASCO Meeting
June 04 2007 - 8:40AM
PR Newswire (US)
Results showed an overall CBR of 52% which compares favorably with
the activity of mTOR inhibitors QUEBEC CITY, QC, June 4
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS), a global biopharmaceutical company focused on endocrine
therapy and oncology, today announced that its partner, Keryx
Biopharmaceuticals (NASDAQ:KERX) presented a poster outlining Phase
1 and Phase 2 results for perifosine, an oral anti-cancer signal
transduction inhibitor compound, for the treatment of patients with
advanced sarcoma. Results of the Phase 1 and Phase 2 studies of
perifosine showed an overall clinical benefit rate (CBR) of 52%
which compares favorably with the activity of mTOR inhibitors. The
poster titled, "Perifosine (P) an active agent in the treatment of
patients with advanced sarcoma": R. Birch, S. Chawla, J.
Nemunaitis, P. Savage, P. Kaiser, A. Spira, A. Cervera, E.
Middleman, E. Sausville, M. Knowling, I. Henderson, was presented
Sunday, June 3, 2007 at the American Society of Clinical Oncology's
(ASCO) Annual Meeting currently being held in Chicago, Illinois.
David J. Mazzo, Ph.D., President and CEO of AEterna Zentaris
commented, "We are very encouraged by the data from these Phase 1
and Phase 2 trials confirming single agent activity with perifosine
in patients with advanced sarcomas, comparable to the activity of
mTOR inhibitors." Background Perifosine is a novel oral
alkylphospholipid that targets the PI3K pathway upstream from mTOR
by inhibiting the phosphorylation of Akt. Perifosine's activity
against sarcomas has now been evaluated in 145 patients enrolled in
one of three Phase 1 trials or four Phase 2 trials. Five of these
trials have been published. Methods Dose categories were as
follows:
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Lower Dose Higher Dose
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Weekly 900 mg or less Weekly 1200 mg or 1500 mg
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Loading Dose 900 mg or less Loading Dose 1200 mg or more
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Daily Dose 100 mg or less Daily Dose 150 mg or more
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The dose schedules in the Phase 1 trials were weekly 100-800 mg or
loading dose (LD) 300-1800 mg on Day 1 followed by 50-150 mg daily
for Days 2-21 every 28 days or LD 400-900 mg & daily 50-100 mg
continuously. In the Phase 2 trials, doses were LD 900 mg Day 1
& 150 mg daily for days 2-21 every 28 days; LD 900 mg and 100
mg daily continuously; 50 mg daily continuously without a LD; and
900-1500 mg weekly. LD was reduced for cycle 2+ of the 28 day
regimens. Results 145 patients with sarcoma were entered on studies
prior to December 31, 2006 and were assessed for CBR. Partial
responses were seen, in one patient each, with chondrosarcoma,
extra-skeletal myxoid chondrosarcoma, leiomyosarcoma and a desmoid
tumor. At lower doses with 52 patients fully evaluable for CBR, the
CBR was 52% with 4 partial responses and 23 stable disease at >=
4 months. At higher doses with 30 patients fully evaluable for CBR,
the CBR was 53% with 16 stable disease at >= 4 months.
Toxicities were mainly gastrointestinal and/or fatigue. The
percentage of patients with grade 0 nausea (N), vomiting (V),
diarrhea (D) and fatigue (F) for lower dose perifosine (76
patients) was 46, 49, 38 and 55% respectively compared to 26, 32,
20 and 58 percent for higher dose perifosine (69 patients). The
proportion of patients with grade 2+ N, V, D and F was 20, 13, 15
and 21% for lower dose perifosine and 49, 35, 42 and 25% for higher
dose perifosine. Conclusions - Perifosine attained an overall 52%
CBR which compares favorably with the activity of mTOR inhibitors;
- Low dose perifosine (daily and weekly) achieved the same CBR as
high dose, including four partial responses; - Toxicities were
mainly gastrointestinal and/or fatigue. Low dose perifosine led to
substantially less toxicity and decreased early withdrawal from
therapy compared to high dose perifosine. A multi-center Phase 2
trial of low-dose perifosine in sarcomas that generally do not
respond to chemotherapy, including chondrosarcoma and myxoid
chondrosarcoma, is currently underway through the Sarcoma Alliance
for Research through Collaboration (SARC) network. About Perifosine
(KRX-0401) Perifosine is a novel, first-in-class, oral anti-cancer
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 1 and Phase 2 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. Perifosine (KRX-0401) is licensed to Keryx
Biopharmaceuticals in the United States, Canada and Mexico. About
AEterna Zentaris Inc. AEterna Zentaris Inc. is a global
biopharmaceutical company focused on endocrine therapy and oncology
with proven expertise in drug discovery, development and
commercialization. News releases and additional information are
available at http://www.aeternazentaris.com/. Forward-Looking
Statements This press release contains forward-looking statements
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include the words "believes", "anticipates", "intends", "plans",
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and the negative or other variations of those terms or comparable
terminology, are forward-looking statements. Such statements
reflect management's current views, intentions, strategies and
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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 ability of AEterna
Zentaris to implement its business strategies, the availability of
funds and resources to pursue R&D projects, the successful and
timely completion of clinical studies, the ability of AEterna
Zentaris 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
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on risks and uncertainties relating to the forward-looking
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forward-looking statements. The Company does not undertake to
update these forward-looking statements. DATASOURCE: AETERNA
ZENTARIS INC. CONTACT: Jenene Thomas, Senior Director, Investor
Relations & Corporate Communications, (908) 938-1475, ; Paul
Burroughs, Media Relations, (418) 652-8525, ext. 406,
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