Sunesis Announces Publication in "Drugs" Detailing Molecular and Pharmacologic Properties of Vosaroxin
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
“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.
“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
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 (
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 Pharmaceuticals
Sunesis 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
Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717