Data and Safety Monitoring Board Recommends Continuation of Sunesis Pharmaceuticals' VALOR Trial Based on Periodic Safety Rev...
14 June 2012 - 9:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the independent Data and Safety Monitoring Board (DSMB) for the
VALOR trial has completed a planned periodic safety review and
recommended that the trial continue as planned without changes to
study conduct. The VALOR trial is a Phase 3, randomized,
double-blind, placebo-controlled, pivotal trial of vosaroxin, the
company's lead product candidate, in patients with first relapsed
or refractory acute myeloid leukemia (AML).
The adaptive design of the VALOR trial also provides for a
single interim analysis by the DSMB, expected in the third quarter
of this year, to examine pre-specified efficacy and safety data
sets and decide whether to stop the study early for efficacy or
futility, continue the study as planned or implement a one-time
sample size adjustment of 225 additional evaluable patients.
Without a sample size adjustment, the unblinding of the trial is
currently expected in 2013.
"The DSMB recommendation to continue VALOR supports the ongoing
execution of this trial and reaffirms our confidence in the
potential of vosaroxin, one of the most advanced and promising
therapies in development for AML today," said Daniel Swisher, Chief
Executive Officer of Sunesis. "We have now enrolled 348 patients, a
figure that reflects strong investigator support and enthusiasm for
the trial and keeps us on track to conduct a pre-specified interim
analysis this coming September."
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 more than 110 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial is currently
enrolling patients, who are 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
Data and Safety Monitoring Board (DSMB) at the interim analysis to
maintain adequate power across a broader range of survival
outcomes. The trial's primary endpoint is overall survival. For
more information on the VALOR trial, please visit
www.valortrial.com.
The VALOR logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8774
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative
(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.
About AML
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 there will be
approximately 13,780 new cases of AML and 10,200 deaths from AML in
the U.S. in 2012. Additionally, it is estimated that the prevalence
of AML across major global markets (U.S., France, Germany, Italy,
Spain, United Kingdom, and Japan) is over 50,000. 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.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
This press release contains forward-looking statements,
including statements related to the occurrence and timing of the
DSMB interim analysis, the design, conduct, progress and results of
the VALOR trial and other clinical trials, the sufficiency of
Sunesis' intellectual property estate and the patent exclusivity
period for vosaroxin in the United States and other jurisdictions,
and vosaroxin's effects, efficacy, safety profile and commercial
potential as a single agent and in combination with cytarabine.
Words such as "on track", "continue", "provides", "expected",
"supports", "reflects" 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 related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of vosaroxin, risks related to Sunesis' ability
to raise the capital that it believes to be accessible and is
required to fully finance the development and commercialization of
vosaroxin, the risk that raising funds through lending arrangements
may restrict our operations or produce other adverse results, the
risk that Sunesis' development activities for vosaroxin could be
otherwise 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 supply of the active pharmaceutical ingredients required for
the conduct of the VALOR trial, the risk of third party opposition
to granted patents related to vosaroxin, and the risk that Sunesis'
proprietary rights may not adequately protect vosaroxin. These and
other risk factors are discussed under "Risk Factors" and elsewhere
in Sunesis' Annual Report on Form 10-K for the year ended December
31, 2011 and Sunesis' other filings with the Securities and
Exchange Commission, including Sunesis' Quarterly Report on Form
10-Q for the quarter ended March 31, 2012, when available. 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 logos are trademarks of Sunesis Pharmaceuticals,
Inc.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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