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SOUTH SAN FRANCISCO, Calif., March 29, 2011 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the fourth quarter and year ended December 31, 2010. Net loss for the three months and year ended December 31, 2010 was $10.1 million and $24.6 million, respectively. As of December 31, 2010, cash, cash equivalents and marketable securities totaled $53.4 million, with no debt outstanding.
"This past year was a landmark year for Sunesis, with our lead program, vosaroxin, moving into a pivotal Phase 3 trial, the VALOR trial, in acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "Since the beginning of the fourth quarter, we achieved a number of critical clinical, regulatory, intellectual property and financial objectives, including the launch of the VALOR trial. I am pleased with the pace of site activation and patient enrollment to date. With an improved capital structure and over $53 million in cash at the end of 2010, Sunesis is today well positioned to reach our goal of bringing an important new cancer treatment to patients with an enduring unmet need."
Fourth Quarter 2010 and Recent Highlights-- Launched Phase 3 VALOR trial of vosaroxin in AML. In December 2010, Sunesis commenced enrollment in its VALOR trial, a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory acute myeloid leukemia (AML). The trial is expected to enroll 450 patients at approximately 100 leading sites in the United States, Canada, Europe, Australia and New Zealand.
-- Granted FDA fast track designation. In February 2011, the FDA granted fast track designation to vosaroxin for the potential treatment of relapsed or refractory AML in combination with cytarabine, providing for the possibility of a "rolling submission" for a marketing application and eligibility for a priority review period by the FDA.
Issued important U.S. and European patents covering vosaroxin clinical formulation. In November 2010, Sunesis announced that the United States Patent and Trademark Office (USPTO) had granted U.S. Patent No. 7,829,577, claiming Sunesis' pharmaceutical compositions of vosaroxin. The patent is scheduled to expire in March 2025, and could be eligible for patent term extension beyond this date. Earlier this March, the European Patent Office (EPO) granted European Patent No. 1725233 covering similar claims as described above. Corresponding patent applications are also pending in other major markets throughout the world, including Japan, Australia and Canada.
-- Presented positive Phase 2 data for vosaroxin in AML. In November 2010, Robert Stuart, MD, Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, presented data from Phase 2 clinical trials of vosaroxin in combination with cytarabine in relapsed/refractory AML and as a single agent in frontline elderly AML at the Chemotherapy Foundation Symposium XXVIII. Consistent with results presented at the American Society of Clinical Oncology Annual Meeting in June 2010, vosaroxin achieved clinically meaningful complete remission rates balanced with low all-cause early mortality. Preliminary leukemia-free survival, measured as time from complete remission to relapse or death, was 14.4 months (440 days). Median overall survival was 7.1 months, with 14 patients continuing in survival follow up well beyond this median.
-- Cash, cash equivalents and marketable securities totaled $53.4 million as of December 31, 2010, as compared to $4.3 million as of December 31, 2009.