Data and Safety Monitoring Board Recommends Continuation of Sunesis Pharmaceuticals' VALOR Trial Based on Periodic Safety Rev...
December 09 2011 - 7:06AM
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 mid-2012, 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 as planned reinforces our
confidence in the design and conduct of the VALOR trial, one of the
largest industry-sponsored trials undertaken in this AML setting,"
stated Daniel Swisher, Chief Executive Officer of Sunesis. "As of
today, 168 patients have been enrolled with more than half being
enrolled since early September, thus highlighting the enthusiasm
for VALOR among our investigators. We hope that the promising
safety/tolerability profile and anti-leukemic activity exhibited by
vosaroxin during our Phase 2 program will translate into improved
clinical outcomes for relapsed and refractory AML patients."
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 approximately 100 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial 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 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
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. 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
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 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
"remains," "hope," "promising," "translate," "provides,"
"advanced," "continue," "available," "planned," "support," "will,"
"expected" 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 results 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
VALOR trial, 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' Quarterly Report on Form
10-Q for the quarter ended September 30, 2011, Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2010 and
Sunesis' 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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