QINPREZO™ (vosaroxin) Partnering Opportunities
Sunesis is evaluating partnership and distributer opportunities to commercialize vosaroxin in select international markets, if approved.
Vosaroxin is an anticancer quinolone derivative (AQD). The molecular core of vosaroxin is structurally similar to quinolones and distinct from anthracyclines and anthracenediones. Vosaroxin's anticancer activity results from apoptosis caused exclusively by DNA intercalation, inhibition of topoisomerase II, and cell cycle inhibition in replicating cells.
Vosaroxin is currently being evaluated in patients with relapsed or refractory acute myeloid leukemia (AML), frontline AML and myelodysplastic syndrome (MDS). The Company recently published results from its Phase 3, multi-national pivotal VALOR trial in Lancet Oncology. VALOR was designed to evaluate the effect of vosaroxin in combination with cytarabine on overall survival as compared to placebo in combination with cytarabine. The trial was conducted at 124 study sites in 15 countries.
In November 2014, based on results of the trial, we submitted a letter of intent to the European Medicines Agency (EMA) describing our intention to file a marketing authorization application (MAA) for marketing authorization of vosaroxin plus cytarabine for the treatment of relapsed or refractory AML. In June 2015, we met separately with our Rapporteur and Co-Rapporteur, who are two appointed members of the EMA's Committee of Human Medicinal Products. Based upon feedback from these meetings, we filed an MAA with the EMA in December 2015. In July 2015, we met with the U.S. Food and Drug Administration (FDA) to discuss a potential regulatory filing in the United States. Based upon the meeting, the FDA recommended that we provide additional clinical evidence prior to any regulatory filing in the U.S. As a result, we will evaluate regulatory and clinical strategies with the goal of gaining future marketing approval in the U.S.
Results from Sunesis' clinical and nonclinical studies of vosaroxin have been reported at numerous conferences, and these posters and presentations may be found here.