Looking like a nice potential niche Dan! Sunesis Pharmaceuticals, Inc. (SNSS)' Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia 11/5/2009 SOUTH SAN FRANCISCO, Calif., Nov. 5 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML. Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees. 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 Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, as well as in an ongoing Phase 2 single-agent trial in platinum-resistant ovarian cancer. AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The Leukemia and Lymphoma Society estimates that nearly 13,000 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2009. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. A majority of elderly patients are not considered candidates for standard induction therapy or decline therapy, resulting in an acute need for new treatment options. Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
Sunesis Pharmaceuticals Receives European Orphan Drug Designation for Vosaroxin to Treat Acute Myeloid Leukemia SOUTH SAN FRANCISCO, Calif., May 3, 2012 (GlobeNewswire via COMTEX) --Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that the European Commission has granted orphan drug designation to vosaroxin, the Company's lead development candidate, for the treatment of acute myeloid leukemia (AML). The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA). "The European Commission's decision reinforces the global potential of vosaroxin and recognizes the desperate need for new treatment options in AML, an indication for which treatment standards have not changed appreciably in the past thirty years," said Dr. Adam Craig, EVP Development & CMO of Sunesis. "European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic. These include the potential for market exclusivity to 2030 and an expedited review process in the U.S., as well as new patents issued in the European Union with exclusivity to 2025." As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. It also provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives for companies developing orphan drug candidates. Orphan drugs are eligible for a reduction of fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies. Sunesis is currently enrolling patients in its VALOR trial, a Phase 3, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukemia. About VALOR VALOR is a Phase 3, 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 U.S., 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 VALOR 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. For more information on the VALOR trial, please visit www.valortrial.com. The VALOR logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8774 About Vosaroxin 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. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. About Sunesis Pharmaceuticals Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com
