SOUTH SAN FRANCISCO, Calif., July 9, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the Pediatric Committee of the European Medicines Agency (EMA) has issued a positive opinion on the Company's Pediatric Investigation Plan (PIP) for Qinprezo™ (vosaroxin), Sunesis' lead drug candidate. Sunesis is currently conducting the VALOR trial, a pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial in patients with first relapsed or refractory acute myeloid leukemia (AML).
A PIP is part of the EMA approval process and must be accepted prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union. A PIP describes how a company intends to evaluate the use of a given drug in children. Completion of studies outlined in the PIP prior to European Union approval is not a requirement for MAA submission if deferral for completion has been received.
"We are pleased with the acceptance of our PIP by the EMA, an important step leading into a potential filing of our Marketing Authorization Application for Qinprezo in Europe," said Daniel Swisher, Chief Executive Officer of Sunesis. "AML remains a significant unmet medical need, one which has seen little innovation in the last 40 years. We look forward to understanding Qinprezo's potential within first relapsed or refractory AML with the unblinding of VALOR expected in the third or fourth quarter of 2014."About Qinprezo™ (vosaroxin) Qinprezo™ (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. Preclinical data demonstrate that Qinprezo 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 Qinprezo for the treatment of AML. Additionally, Qinprezo has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Qinprezo is an investigational drug that has not been approved for use in any jurisdiction.