Sunesis Pharmaceuticals, Inc. announced that the European Patent Office (EPO) has granted a European patent covering combinations of the company's lead drug candidate, voreloxin, with cytarabine.

Cytarabine is the standard-of-care treatment for Acute Myeloid Leukaemia (AML), and the therapy used in combination with voreloxin in a fully enrolled phase 2 trial in patients with relapsed and/or refractory AML.

Sunesis has also announced plans to initiate a multinational, randomized, double-blind, placebo-controlled, pivotal phase 3 clinical trial of voreloxin in combination with cytarabine in a relapsed/refractory AML patient population in the second half of this year. European Patent No. 1 729 770 B1, titled "SNS-595 [voreloxin] and Methods of Using the Same," following completion of the patent validation process, will provide patent coverage for such combination products in 30 member states of the European Patent Convention, including the major European markets, through 2025. Corresponding patent applications are pending in major markets throughout the world including Australia, Canada, Japan and the United States.

"This patent is an important new addition to our intellectual property estate, as it covers the combination of voreloxin and cytarabine, the contemplated initial market application," stated Daniel Swisher, chief executive officer of Sunesis. "We are pursuing a sophisticated and deliberate strategy to provide exclusive coverage in the voreloxin patent estate out to 2030. Beyond our granted patents, we have filed patent applications covering formulations, combination uses, dosing, manufacturing processes and composition of matter claims. We look forward to the successful prosecution of these patent applications in multiple territories around the world."

Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent clinical trial in platinum-resistant ovarian cancer has also completed enrolment. Sunesis plans to initiate a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of voreloxin in combination with cytarabine in a relapsed/refractory AML patient population in the second half of this year.

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