Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
publication of an article detailing the molecular and pharmacologic
properties of vosaroxin as a new therapeutic for acute myeloid
leukemia (AML) in the journal Drugs. The article, titled “Molecular
and Pharmacologic Properties of the Anticancer Quinolone Derivative
Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia,” is
available online and will appear in the September 2016 print issue
of Drugs.
The authors describe how the unique chemical and
pharmacologic characteristics of vosaroxin, the first
quinolone-based topoisomerase II inhibitor studied in clinical
trials in cancer, may contribute to the efficacy and safety profile
observed in Sunesis’ Phase 3 VALOR trial, a randomized,
double-blind, placebo-controlled trial of vosaroxin and cytarabine
in patients with first relapsed or refractory AML. Vosaroxin
is a DNA intercalating topoisomerase II inhibitor that causes the
induction of apoptosis via double-strand DNA breaks, yet is
chemically distinct from other topoisomerase inhibitors with its
stable quinolone-based core. Due to the stability of this core,
vosaroxin is not associated with significant formation of toxic
metabolites, free radicals, or reactive oxygen species, which are
associated with off-target organ damage and cardiotoxicity.
Furthermore, vosaroxin evades two common mechanisms of drug
resistance, as it is not a substrate for the P-glycoprotein efflux
pump and its activity is maintained in cells with p53
deletion.
In the pivotal Phase 3 VALOR trial, a 2.1-month
improvement in median OS among patients ≥ 60 years old was
demonstrated, without an increase in early mortality, as compared
to the control arm. Common side effects of vosaroxin included
gastrointestinal effects, myelosuppression, and infection.
Vosaroxin also demonstrates potent in vitro antitumor activity in
various tumor types, including those resistant to other
topoisomerase II inhibitors.
Vosaroxin is currently being tested in several
investigator-sponsored studies, both as a single-agent and in
combination with other therapies, for the treatment of AML and
myelodysplastic syndromes. A Marketing Authorization Application
for vosaroxin as a treatment for AML in Europe is currently under
review by the European Medicines Agency.
“The chemical and pharmacologic characteristics
of vosaroxin, including its chemically stable quinolone core, low
off-target organ damage and ability to overcome common resistance
factors, highlight its potential as a new and differentiated
treatment option for certain cancers,” stated Dr. Stephen A.
Strickland, M.D., MSCI, Clinical Director of Acute Leukemia,
Division of Hematology/Oncology at the Vanderbilt-Ingram Cancer
Center, Assistant Professor of Medicine, Vanderbilt University
Department of Medicine, and a lead author of the publication. “In
particular, vosaroxin may be an effective therapeutic alternative
for older AML patients, those with treatment-resistant disease, and
those who have exceeded safe thresholds for anthracyclines or are
at high risk for treatment-related cardiac damage. Overall, I
believe vosaroxin represents a much needed treatment for patients
with relapsed or refractory AML.”
“Publication of this profile on vosaroxin in
Drugs supports our goal of establishing vosaroxin as a meaningful
advancement in the standard of care for patients with AML,” said
Daniel Swisher, Chief Executive Officer of Sunesis. “As we continue
through the process for regulatory approval of vosaroxin in Europe,
we also look forward to expanding the body of supportive data
behind this therapeutic candidate as we advance several ongoing and
planned investigator- or company-sponsored clinical studies.”
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer
quinolone derivative (AQD), a class of compounds that has not been
used previously for the treatment of cancer. Preclinical data
demonstrate that 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 AML. Additionally,
vosaroxin has been granted fast track designation by
the FDA for the potential treatment of relapsed or
refractory AML in combination with cytarabine. Vosaroxin is an
investigational drug that has not been approved for use in any
jurisdiction.
Vosaroxin’s Marketing Authorization Application
for relapsed refractory AML is currently under review by
the European Medicines Agency, and a regulatory decision
regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name
for the vosaroxin drug product candidate.
About Sunesis
PharmaceuticalsSunesis is a biopharmaceutical company
focused on the development and commercialization of new oncology
therapeutics for the potential treatment of solid and hematologic
cancers. Sunesis has built a highly experienced cancer drug
development organization committed to improving the lives of people
with cancer. Currently, the company is focused on pursuing
regulatory approval in Europe for its lead product
candidate, vosaroxin, for the treatment of relapsed or refractory
acute myeloid leukemia in patients aged 60 and older, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary non-covalent BTK-inhibitor, SNS-062.
For additional information on Sunesis, please
visit http://www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to Sunesis' corporate
objectives, including the anticipated progress and potential
approval of vosaroxin by the EMA, timing of potential market launch
in Europe for vosaroxin, and further clinical development
of vosaroxin and SNS-062. Words such as “believe,” “goal,” “look
forward,” "potential," "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, the risk that Sunesis may not be able
to receive regulatory approval of vosaroxin in the U.S.
or Europe, that Sunesis' development activities for vosaroxin
could be otherwise halted or significantly delayed for various
reasons, the risk that Sunesis' clinical studies for vosaroxin or
other product candidates, including its pipeline of kinase
inhibitors, 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, risks related to the
conduct of Sunesis' clinical trials, risks related to Sunesis' need
for substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, and
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 and other product
candidates. 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, 2015, Sunesis’ Quarterly Report on
Form 10-Q for the quarter ended June 30, 2016, when available,
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 Sunesis' expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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