Sunesis Pharmaceuticals, Inc. announced that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's proposed plans for further development of voreloxin in acute myeloid leukaemia (AML), including the company's plans for a pivotal trial in patients with first relapsed or primary refractory AML. The EMA's written advice, similar to guidance previously received from the US Food and Drug Administration (FDA) in February following formal End-of-phase 2 meetings, is consistent with and supportive of Sunesis' proposed plans, and provides development clarity toward a potential regulatory submission for marketing approval. The EMA issued its advice following its established consultative review process.

The company continues to anticipate a launch of its multi-national, randomized, double-blind, placebo-controlled phase 3 trial in the second half of 2010. Based on feedback and guidance received from the FDA and EMA, the company expects that future results demonstrating a convincing magnitude of improvement in overall survival, the study's primary endpoint, along with a favourable benefit-risk ratio in the planned phase 3 trial, would be sufficient as the primary basis for registration of voreloxin in both the US and Europe.

"With the EMA's scientific advice, we have successfully completed an important step in our global development strategy for voreloxin in relapsed and refractory AML," stated Daniel Swisher, chief executive officer of Sunesis. "The company, its advisors and clinical service providers continue to collaborate toward the successful initiation of our multi-national phase 3 trial in the second half of this year."

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 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a phase 3 trial of voreloxin in AML in the second half of 2010.

Sunesis anticipates initiating a phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the US and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.

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