DSMB Recommends Increase Following
Single, Pre-Planned Interim Efficacy and Safety Analysis of VALOR;
Enrollment Completion Expected in 2013 DSMB
Recommendation Triggers $25.0 Million Investment in Sunesis from
Royalty Pharma Sunesis to Host Conference Call
Today at 9:00 AM Eastern Time
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it
will implement a one-time, 225-patient sample size increase to its
Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML),
bringing target enrollment to 675 patients. This is in response to
the recommendation of the trial's independent Data and Safety
Monitoring Board (DSMB) following their completion yesterday of a
single, pre-planned interim analysis of unblinded efficacy and
safety data sets from VALOR.
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial of vosaroxin in patients with
first relapsed or refractory AML. The pre-planned sample size
increase of 225 additional patients is designed to maintain
adequate statistical power over a broader range of survival
outcomes. With the revised target sample size of 675 patients,
Sunesis anticipates full enrollment of VALOR in 2013, with
unblinding of the trial expected in the first half of 2014 upon
reaching 562 events and final database lock. The DSMB
recommendation also triggers Royalty Pharma's obligation to invest
$25.0 million in Sunesis.
"The completion of VALOR's interim analysis is an important
milestone for Sunesis," said Daniel Swisher, Chief Executive
Officer of Sunesis. "In light of the design of VALOR, the DSMB's
recommendation that we implement a one-time, 225-patient sample
size increase is a promising development. We thank the DSMB for
their comprehensive analysis, and trial investigators for their
continued support of VALOR, which has now enrolled 412 patients.
Importantly, we are pleased that we have committed funding that
will allow us to implement this enrollment expansion and complete
the pivotal trial in AML."
Sunesis' management and staff, VALOR clinical investigators,
including members of the Study Steering Committee, and Royalty
Pharma remain blinded to the interim trial data and
analysis.
Royalty Pharma's $25.0 million investment is made pursuant to
the terms of an agreement with Sunesis announced March 29,
2012. In exchange for their investment, Royalty Pharma will
receive a 6.75% royalty on future net sales of vosaroxin and
warrants to purchase Sunesis common stock.
Conference Call Information
Sunesis will host an update conference call today, September
11th at 9:00 a.m. Eastern Time. The call can be accessed by dialing
(866) 700-6293 (U.S. and Canada) or (617) 213-8835 (international),
and entering passcode 65702894. To access the live audio webcast,
or the subsequent archived recording, visit the "Investors and
Media - Calendar of Events" section of the Sunesis website at
www.sunesis.com. The webcast will be recorded and available for
replay on the company's website for two weeks.
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial's target enrollment is 675 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. 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. Both the
U.S. Food and Drug Administration (FDA) and European Commission
have granted orphan drug designation to vosaroxin for the treatment
of acute myeloid leukemia. Additionally, vosaroxin has been
granted fast track designation by the FDA for the potential
treatment of relapsed or refractory acute myeloid leukemia in
combination with cytarabine.
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
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
This press release contains forward-looking statements,
including statements related to the design, conduct, progress and
results of the VALOR trial, vosaroxin's effects, efficacy, safety
profile and commercial potential as a single agent and in
combination with cytarabine, and the timing and occurrence of
Royalty Pharma's proposed investment of $25.0 million in Sunesis.
Words such as "expected," "will," "triggers," "designed,"
"anticipates," "continued," "anticipates" 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' Quarterly Report on Form
10-Q for the quarter ended June 30, 2012, Sunesis' Annual Report on
Form 10-K for the year ended December 31, 2011 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Sunesis Pharmaceuticals (NASDAQ:SNSS)
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