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VALOR Enrollment Exceeds 675 Patients Cardiff University-Sponsored LI-1 Trial Monotherapy Treatment Arm Evaluated by DMEC
Investigator-Sponsored Phase I/II Trial Evaluating Vosaroxin in Combination with Decitabine in AML and MDS Initiated at MD Anderson Cancer Center Sunesis to Host Conference Call Today at 5PM Eastern Time
SOUTH SAN FRANCISCO, Calif., July 29, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended June 30, 2013. Loss from operations for the three and six months ended June 30, 2013 was $8.6 million and $16.4 million, respectively. As of June 30, 2013, cash, cash equivalents and marketable securities totaled $49.6 million.
"We continue to make substantial progress with the VALOR trial, a study with transformational potential in the treatment of AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "With the goal of reaching a final sample size of at least 675 evaluable patients, the trial was designed to over enroll by 5% to 712 patients. As of today, enrollment has exceeded 675 patients, and we now expect to complete enrollment this quarter, with unblinding of the trial expected in the first half of 2014."
Mr. Swisher added: "As to the Cardiff University-sponsored LI-1 trial in front-line elderly AML, we have been informed that the DMEC will recommend that the monotherapy vosaroxin arm discontinue enrollment. We will be working closely with Cardiff University to better understand the outcomes in this study arm, and why they differed from our Phase 2 REVEAL-1 trial. We are confident in vosaroxin's broader potential, which we continue to explore through investigator-sponsored studies, such as the newly initiated MD Anderson Cancer Center trial in previously untreated AML and MDS."
Regarding the MD Anderson Cancer Center-sponsored, Phase I/II trial of vosaroxin and decitabine in AML and high-risk MDS, Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis, added: "This trial allows for the expanded development of vosaroxin in difficult-to-treat AML and MDS populations. Unique and non-overlapping anti-leukemic activities make vosaroxin and decitabine well suited for frontline combination therapy. We look forward to monitoring the progress of this study and to supporting MD Anderson and others in exploring the full potential of vosaroxin."