AEterna Zentaris Announces Positive Data of Perifosine (KRX-0401) in patients with advanced renal cell carcinoma at ASCO Meetin
June 05 2006 - 8:15AM
PR Newswire (US)
Interim Results of a multi-center Phase 2 trial by partner Keryx
Biopharmaceutical shows a 43% partial response rate QUEBEC CITY,
Canada, June 5 /PRNewswire-FirstCall/ -- AEterna Zentaris' (TSX:
AEZ; NASDAQ: AEZS) North American partner Keryx Biopharmaceuticals
(NASDAQ:KERX) disclosed positive data of perifosine (KRX-0401) in
patients with advanced renal cell carcinoma (RCC). These patients
were a cohort of a phase 2, multi- center, trial of perifosine that
included multiple tumor types. All patients in this study were to
have had prior standard therapy. Although the extent of prior
treatment varied with tumor type, most patients had received two
chemotherapy regimens for metastatic disease. An interim analysis
was performed at the end of the first year of accrual, and the
results in the renal group met protocol requirements for expansion
of this cohort. The study is ongoing. Thirteen patients with
advanced renal cell carcinoma (RCC) were enrolled in the study and
7 were evaluable for response. Three of these (43%) had a partial
response and an additional 2 patients (29%) achieved long-term
stable disease. Two progressed. Four patients were inevaluable
because they stopped treatment early (42 -62 days) and their
disease was not evaluated at the time drug was stopped. Two
patients have not been on study long enough to reach the first
point of evaluation. Responses were scored using RECIST criteria.
> Times with '+' meaning patient still stable or responding at
time of analysis. Additional renal patients will be enrolled on
this study, including patients with prior exposure to sorafenib and
sunitinib. Keryx anticipates that phase 1 studies combining
perifosine with approved agents for the treatment of renal cell
cancer will be opened within 6-8 weeks. Larger and more definitive
phase 2 and phase 3 trials are being developed, and it is
anticipated that one or more of these will be initiated in the next
6 - 12 months. "The Akt pathway is frequently activated in renal
cell cancers. It follows that this tumor type may be particularly
responsive to Akt inhibition, and we think these studies with
perifosine may be providing early evidence of this", said I. Craig
Henderson, M.D., President of Keryx Biopharmaceuticals. Henderson
also added, "Therapy with perifosine could potentially provide an
important advancement in the treatment of renal cell carcinoma, a
disease that affects 39,000 new patients every year in the US."
"Recent approvals of sorafenib and sunitinib provide great hope for
patients with renal cell carcinoma. However, additional treatments
are desperately needed, particularly agents with a different
mechanism of action", stated Robert Figlin, MD, professor of
medicine and urology, David Geffen School of Medicine at UCLA.
"This response data is preliminary but of great interest and we are
anxious to further explore the potential of perifosine, a novel
agent that targets Akt and other important pathways known to cause
resistance in renal cell carcinoma." Dr. Jurgen Engel, Executive
Vice President, Global R&D and Chief Operating Officer at
AEterna Zentaris concluded, "I believe this data is proof of
perifosine's anticancer activity as a monotherapy agent in this
specific indication, which may open other multiple opportunities."
About the Phase 2 Trial Design This Keryx-sponsored, exploratory
trial was designed to evaluate the safety and efficacy of two
schedules of perifosine (KRX-0401) in patients with a variety of
tumor types. From February 2005 to February 2006, patients at over
30 centers across the US were randomized to receive either 50 mg of
perifosine once daily or 1200 mg on a weekly dose schedule. The
protocol was designed to accrue 11 patients in a given tumor type
and then expand that cohort to 26 patients if a favorable outcome
is seen in at least 1 of the first 11 patients. The study continues
to enroll patients, and no cohort defined by tumor type has been
closed because of insufficient evidence of activity. The responses
we have seen in this advanced renal cell carcinoma cohort did not
appear dose-dependent as partial responses and stable disease were
noted in both dose groups. This is consistent with prior data with
perifosine where responses have been equally distributed between
higher and lower dose groups. Toxicity The 50 mg dose has been
extremely well tolerated. The main toxicities were nausea,
vomiting, diarrhea, and fatigue. Nearly half (42%) of the patients
on this dose had none of these symptoms, and 89% had no
gastrointestinal toxicity above grade 1. The incidence of grade 2
or greater toxicity with the weekly dose was considerably higher,
but even in this group nearly 20% experienced none of these side
effects and one third no gastrointestinal toxicity above grade 1.
The frequency of grade 2 or higher toxicity by study arm was: >
About Renal Cell Carcinoma RCC represents approximately 2% to 3% of
all adult cancers worldwide and 2% of all cancer-related deaths. In
2006, an estimated 39,000 new cases of RCC and 13,000 deaths
attributable to RCC are expected in the US. The National Cancer
Institute reports a rising incidence of RCC at a rate of
approximately 2% per decade. The disease occurs predominantly in
the seventh and eighth decades in life, and it affects nearly twice
as many men as women. About Perifosine (KRX-0401) 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. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is a growing global biopharmaceutical company engaged
in the discovery, development and marketing of therapies for cancer
and endocrine disorders. AEterna Zentaris also owns 48.29% of the
equity of Atrium Biotechnologies Inc. (TSX: ATB.sv) and 64.7% of
its voting rights. Atrium is a developer, manufacturer and marketer
of science-based products for the cosmetics, pharmaceutical,
chemical and nutritional industries. News releases and additional
information are available at http://www.aeternazentaris.com/.
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ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
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