Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
publication of a peer-reviewed paper in the August 2012 issue of
Expert Opinion on Investigational Drugs (Volume 21, Number 8)
featuring vosaroxin, the Company's lead product candidate currently
being evaluated in a Phase 3 trial, the VALOR trial, for the
treatment of relapsed or refractory acute myeloid leukemia (AML).
The paper, titled "Vosaroxin: a novel antineoplastic quinolone,"
was written by Jonathan Abbas, MD, and Robert Stuart, MD, of the
Medical University of South Carolina, Hollings Cancer Center. The
paper provides an in-depth review of the development history of
vosaroxin, its mechanism of action, pharmacology, metabolism, as
well as preclinical and clinical data to date, and is available
online at
http://informahealthcare.com/doi/pdf/10.1517/13543784.2012.699038.
Among the findings in the paper, the authors point out:
"Vosaroxin is at once both different and familiar. It is unarguably
a structurally novel antineoplastic, but its mode of action and
ability to be used in combination with cytarabine suggest that it
will be easy to adopt in practice. Several unique features make
vosaroxin a particularly attractive chemotherapy agent including
its resistance to P-glycoprotein-mediated drug efflux and its lack
of chemical reactivity, which by not promoting the formation of
reactive oxygen species, should minimize adverse effects, most
notably cardiotoxicity. Further, single-agent vosaroxin is capable
of inducing complete remissions in poor-risk older AML patients
with low early mortality, demonstrating its potential in difficult
to treat AML populations."
Sunesis is currently evaluating vosaroxin in a pivotal Phase 3,
randomized, double-blind, placebo-controlled trial, the VALOR
trial, in patients with first relapsed or refractory acute myeloid
leukemia (AML). The VALOR trial employs an adaptive trial design
that permits a one-time increase in sample size at the interim
analysis by its Data and Safety Monitoring Board (DSMB). At the
interim analysis, expected in the third quarter of 2012, the DSMB
will 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.
Sunesis is also participating in a Phase 2/3 randomized,
controlled, multicenter trial evaluating novel treatment regimens,
including two regimens containing vosaroxin, against low dose
cytarabine in elderly AML or high-risk myelodysplastic syndrome
(MDS) patients who are not candidates for intensive chemotherapy.
The trial, known as the Less Intensive 1 (LI-1) Trial, is being
sponsored by Cardiff University and conducted by the United
Kingdom's National Cancer Research Institute Haematological
Oncology Study Group under the direction of Professor Alan K.
Burnett.
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
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
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 "suggest," "should", "is capable", "demonstrating",
"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 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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