AEterna Zentaris Announces Positive Interim Phase 2 Data on Perifosine (KRX-0401) in Patients with Relapsed and Refractory Multi
December 11 2006 - 10:45AM
PR Newswire (US)
Interim data analysis shows induction of response and/or disease
stabilization in 69% of evaluable patients in combination with
Dexamethasone QUEBEC CITY, QC, Dec. 11 /PRNewswire-FirstCall/ --
AEterna Zentaris Inc. (TSX : AEZ, NASDAQ : AEZS) along with its
partner, Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX), today
announced that Dr. Paul Richardson, Clinical Director of the Jerome
Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute
(DFCI) in Boston, MA reported positive interim results from the
Phase 2 study of perifosine in patients with advanced relapsed and
refractory multiple myeloma (MM) at the American Society of
Hematology (ASH) 48th Annual Meeting and Exposition in Orlando, FL.
Perifosine is currently being evaluated in Phase 2 clinical trials
as a single agent and in combination with other anti-cancer agents
across several tumor types. Dr. Richardson, along with Dr. Ken
Anderson at DFCI and other leading investigators from MM centers
including Emory University, University of Michigan, Alta Bates,
City of Hope, University of Virginia and Northwestern University
have been instrumental in the pre-clinical and clinical development
of perifosine for MM. The conclusion of the investigators is that
perifosine alone or in combination with dexamethasone has activity
in patients with advanced, relapsed/refractory MM, achieving
response and/or stabilization of disease in 69% of evaluable
patients to date. The poster (Abstract # 3582), entitled "A
Multicenter Phase II Study of Perifosine (KRX-0401) Alone and in
Combination with Dexamethasone (Dex) for Patients with Relapsed or
Relapsed/Refractory Multiple Myeloma (MM)," is available for
viewing today, December 11th, 2006 at the Orange County Convention
Center. In this ongoing Phase 2 study, patients with relapsed or
relapsed/refractory MM are treated with perifosine (150 mg oral
daily dose) to assess the single agent activity of perifosine in
this patient population. If a patient progresses on perifosine
alone, dexamethasone (20 mg twice weekly) is added to their
perifosine regimen. Results 55 patients (30 men and 25 women,
median age 63 years, range 3879) have been treated to date. All
patients had relapsed and refractory MM, with a median of 4 lines
of prior treatment (range 2 - 11). Prior therapy included dex
(95%), thalidomide (89%), bortezomib (78%), lenalidomide (31%) and
stem cell transplant (73%). Among 33 patients currently evaluable
for response, best response (European Group for Blood Marrow
Transplant "EBMT"/Blade criteria) to single agent perifosine after
2 or more cycles, was stable disease (less than 25% reduction in
M-protein) in 13 patients (39%). Dexamethasone was added in 30 of
55 patients with progressive disease (PD), with 23 patients
evaluable for response on the combination, reported as follows:
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Perifosine + Dex N (%) Duration (wks)
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PR 2 (9%) 13+, 17+
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MR 4 (17%) 4, 16+, 28+, 30+
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Stable Disease 11 (48%) 6 - 20+ (median 18)(x)
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(x)4 pts ongoing at 16, 18, 20 and 20 weeks
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The most common Grade 3/4 adverse events were nausea (7%), vomiting
(4%), diarrhea (2%), fatigue (2%), and increased creatinine (8% in
the context of PD and light chain nephropathy). Dose reduction (150
to 100 or 50 mg/d) was required in 16 patients and 7 patients
discontinued treatment due to adverse events. Attributable
toxicities otherwise proved manageable with appropriate supportive
care. Perifosine was generally well tolerated, with no peripheral
neuropathy or deep vein thrombosis seen. Dr. Jurgen Engel,
Executive Vice President, Global R&D and Chief Operating
Officer at AEterna Zentaris commented, "We are very pleased with
the anti-tumor activity and the manageable toxicity profile
witnessed with the treatment of perifosine in patients with
multiple myeloma. The data received on perifosine thus far is quite
encouraging, and we remain committed to the further evaluation of
perifosine alone or in combination with other novel agents as well
as with radiotherapy." Perifosine (KRX-0401) is out-licensed to
Keryx Biopharmaceuticals from AEterna Zentaris, Inc. in the United
States, Canada and Mexico while AEterna Zentaris retains rights for
the rest of the world. About Perifosine 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. About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a growing 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 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. CONTACT: Media Relations: Paul Burroughs, (418)
652-8525 ext. 406, ; Investor Relation: Jenene Thomas, (418)
655-6420,
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