Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that
the first patient has been randomized and dosed with blinded study
treatment in its pivotal Phase 3 VALOR trial of vosaroxin, the
company's lead drug candidate, in combination with cytarabine in
patients with first relapsed or refractory acute myeloid leukemia
(AML). The VALOR trial is a multinational, randomized,
double-blind, placebo-controlled, pivotal trial which is expected
to enroll 450 evaluable patients at leading sites in the U.S.,
Canada, Europe, Australia and New Zealand.
"The initiation of VALOR marks the culmination of many years of
work and is a gratifying moment for Sunesis in its ongoing efforts
to develop a new therapeutic option for AML patients," stated
Daniel Swisher, Chief Executive Officer of Sunesis. "AML is a
challenging disease, especially for relapsed and refractory
patients, yet in our robust Phase 2 program we have shown in this
AML setting that vosaroxin plus a leading standard of care,
cytarabine, exhibit a combination of efficacy and tolerability that
has led to promising results. The support of key opinion leaders,
top international trial sites, specialized service providers and a
rigorously designed Phase 3 protocol should provide the VALOR trial
with a strong foundation for operational success."
"Patients with relapsed or refractory AML have a poor prognosis
and are often intolerant of or do not respond to currently
available treatment options," said Farhad Ravandi, M.D., Associate
Professor, Department of Leukemia, Division of Cancer Medicine, The
University of Texas M. D. Anderson Cancer Center, and a principal
investigator of VALOR. "Despite the unmet medical need, treatment
standards have not appreciably changed in more than 30 years.
Vosaroxin's differentiated treatment profile from the Phase 2
program is characterized by strong remission rates, low all-cause
early mortality and long leukemia free survival, which have led to
survival outcomes that compare favorably with published results for
current treatment standards. The VALOR trial is a well designed,
highly anticipated trial which should provide a clear understanding
of vosaroxin's efficacy and safety profile when added to cytarabine
in this disease setting."
Patients in the VALOR trial will be randomized one-to-one to
receive in a blinded manner either vosaroxin or placebo on days one
and four of each treatment cycle in combination with cytarabine
daily for five days of each treatment cycle. The trial's primary
endpoint is overall survival. The VALOR trial employs an adaptive
design that provides for a single interim analysis by an
independent Data and Safety Monitoring Board (DSMB) which will meet
to examine pre-specified efficacy and safety data sets and decide
whether to implement a one-time sample size adjustment of 225
additional evaluable patients to maintain adequate power across a
broad range of clinically meaningful and statistically significant
survival outcomes. The interim analysis by the DSMB is expected to
take place in mid-2012. For more information on VALOR please visit
www.valortrial.com.
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial is expected to enroll 450 evaluable
patients at leading sites in the U.S., Canada, Europe, Australia
and New Zealand. VALOR is currently open for enrollment and
patients will be randomized one-to-one to receive either vosaroxin
on days one and four in combination with cytarabine daily for five
days, or placebo in combination with cytarabine. Additionally, the
VALOR trial employs an innovative, adaptive trial design that
allows for a one-time sample size adjustment by the DSMB at the
interim analysis to maintain adequate power across a broad range of
clinically meaningful and statistically significant survival
outcomes. The trial's primary endpoint is overall survival. For
more information on VALOR please visit www.valortrial.com.
About Vosaroxin
Vosaroxin, formerly known as voreloxin, is a first-in-class
anticancer quinolone derivative, or AQD, a class of compounds that
has not been used previously for the treatment of cancer. Vosaroxin
both intercalates DNA and inhibits topoisomerase II, resulting in
replication-dependent, site-selective DNA damage, G2 arrest and
apoptosis. Sunesis is currently enrolling patients in the VALOR
trial, a multinational, randomized, double-blind,
placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in
combination with cytarabine in a relapsed/refractory AML patient
population.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates that 12,330 new
cases of AML will be diagnosed and approximately 9,000 deaths from
AML will occur in the U.S. in 2010. Additionally, it is estimated
that prevalence of AML is approximately 25,000 in the U.S. AML is
generally a disease of older adults, and the median age of a
patient diagnosed with AML is about 67 years. AML patients with
relapsed or refractory disease and newly diagnosed AML patients
over 60 years of age with poor prognostic risk factors typically
die within one year, resulting in an acute need for new treatment
options for these patients.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to advancing its lead product candidate, vosaroxin, in multiple
indications to improve the lives of people with cancer. For
additional information on Sunesis, please visit
http://www.sunesis.com.
This press release contains forward-looking statements,
including statements related to the design, conduct, timing of
interim analysis and results of the VALOR trial, and vosaroxin's
effects, efficacy and safety profile as a single agent and in
combination with cytarabine. Words such as "designed," "expected,"
"exhibit," "promising," "should," "will" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties related to Sunesis' need for substantial additional
funding to complete the development and commercialization of
vosaroxin, the risk that unfavorable economic and market conditions
may make it more difficult and costly to raise additional capital,
the risk that Sunesis' development activities for vosaroxin could
be halted or significantly delayed for various reasons, the risk
that Sunesis' clinical studies for vosaroxin may not demonstrate
safety or efficacy or lead to regulatory approval, the risk that
data to date and trends may not be predictive of future data or
results, the risk that Sunesis' nonclinical studies and clinical
studies may not satisfy the requirements of the FDA or other
regulatory agencies, risks related to the conduct of Sunesis'
clinical trials, risks related to the manufacturing of vosaroxin,
and the risk that Sunesis' proprietary rights may not adequately
protect vosaroxin. Risk factors related to Sunesis and its business
are discussed under "Risk Factors" and elsewhere in Sunesis'
Quarterly Report on Form 10-Q for the quarter ended September 30,
2010 and other filings with the Securities and Exchange Commission.
Sunesis expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in the company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals,
Inc.
Investor and Media Inquiries: David Pitts Argot Partners
212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.
650-266-3717
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