On August 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported 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 (Press release, Sunesis, AUG 25, 2016, View Source [SID:1234514730]). 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. Schedule your 30 min Free 1stOncology Demo! 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.
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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.