Sunesis Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and haematologic cancers,  announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for US Patent Application No. 12/982,785 claiming certain compositions related to its lead drug candidate, vosaroxin.

The patent will grant Sunesis exclusive rights to certain Active Pharmaceutical Ingredient (API) compositions of vosaroxin, as well as the final product related to such compositions, and provides patent exclusivity to mid 2030 in the United States. A family of corresponding patent applications are pending in the US and internationally.

“The '785 patent is an important aspect of our intellectual property estate. Once granted, the patent will provide significant additional patent protection and support market exclusivity for vosaroxin out nearly two decades to 2030,” stated Daniel Swisher, chief executive officer of Sunesis. “The successful pursuit of this patent is another step in our intellectual property strategy, a strategy which provides Sunesis with greater certainty in pursuing the full clinical and commercial potential of vosaroxin. We look forward to additional important milestones for vosaroxin this year, including an interim analysis of the phase III VALOR trial.”

Sunesis is currently enrolling patients with more than 110 active sites open in 14 countries in the VALOR trial, a phase III, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukaemia.

VALOR is a phase III, 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 approximately 110 leading sites in the US, 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 trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial's primary endpoint is overall survival.

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. It intercalates both the DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and haematologic cancers.