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Sunesis Announces Study Examining the Value of Complete Remission Prior to HCT in Patients with AML Presented at 2016 ASCO Annual Meeting

Study Funded Jointly by Sunesis and the Center for International Blood and Marrow Transplant Research

SOUTH SAN FRANCISCO, Calif., June 06, 2016 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced the presentation of results from a study conducted by the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin evaluating the value of achieving complete remission prior to allogeneic hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML). The study was funded jointly by Sunesis and CIBMTR. The results are being presented today, Monday, June 6th from 8:00 a.m. to 11:30 a.m. Central Time at the Hematologic Malignancies – Leukemia, Myelodyplastic Syndromes, and Allotransplant General Poster Session of the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois.

The poster presentation (Poster #25, Abstract 7033, Hall A), titled “Allogeneic transplantation for advanced acute myelogenous leukemia: The value of complete remission,” will be available on the Sunesis website at, following the ASCO presentation.

For the study, researchers evaluated records from 4,382 patients with AML who had proceeded to allogeneic transplantation to understand comparative survival between those in complete remission following additional salvage therapy and those receiving prompt HCT without achieving complete remission or in first relapse following primary induction.  Of the 4,382 patients, 1,440 had transplantation in primary induction failure (PIF), 1,256 were first relapse (Rel1), and 1,986 had achieved a second complete remission (CR2). Baseline characteristics were similar in the three disease status groups.

The results showed that more patients who had achieved CR2 had de novo AML, a longer duration of a first complete remission (CR1), and were more likely to report performance scores of 90 or 100. Adverse cytogenetics were more common in PIF patients and duration of CR1 was shorter in patients with Rel1 than in those with CR2. Mortality was higher for HCT in Rel1 compared to CR2 regardless of CR1 duration (RR 1.65, p < 0.0001). Similarly, mortality was higher for HCT in PIF compared to CR2 with CR1 duration < 6 (RR 1.26, p < 0.0001), 6-12 (RR 1.60, p < 0.0001) and > 12 months (RR 2.24, p < 0.0001). The probabilities of overall survival by disease status at 6 months are: CR2 73 (71-75)%; Rel1 53 (50-55)%; PIF 58 (56-61)%; and at 2 years, CR2 50 (48-52)%; REL1 27 (24-29)%; PIF 29 (27-32)%.

The data suggest that patients in remission fare better following HCT than those who receive transplant without having achieved CR, and that the ability to achieve remission is a powerful prognostic marker.

“These data point to the importance of achieving remission as an indicator of prognosis after HCT for patients with relapsed/refractory AML, and underscore the need for an effective salvage therapy,” said Parvinder S. Hyare, Vice President, Global Oncology Operations and an author of the study. “We thank CIBMTR and their collaborators for this important research, and continue to work toward delivering new treatment options to high unmet need patients with AML around the world.”

About Sunesis Pharmaceuticals

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer and is currently pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older. In addition, the company is advancing its kinase-inhibitor pipeline of novel targeted therapies into the clinic.

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This press release contains forward-looking statements, including statements related to Sunesis' corporate objectives, including the anticipated progress and potential approval of vosaroxin by the EMA, potential ex-US partnership, and the expected progress in its kinase inhibitor pipeline. Words such as “prospects,” “look forward,” "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis may not be able to receive regulatory approval of vosaroxin in the U.S. or Europe, that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin or other product candidates, including its pipeline of kinase inhibitors, may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of Sunesis' clinical trials, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin and other product candidates, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin and other product candidates. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-Q for the year ended May 9, 2015 and Sunesis' other filings with the Securities and Exchange Commission.  Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

About CIBMTR® (Center for International Blood and Marrow Transplant Research®)
A research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin, CIBMTR facilitates critical, cutting-edge research that has led to increased survival and an enriched quality of life for thousands of patients. CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation and cellular therapy research worldwide. The prospective and observational research is accomplished through scientific and statistical expertise, a large network of transplant centers and clinical database of more than 425,000 transplant recipients.

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Eric Bjerkholt
Sunesis Pharmaceuticals Inc.

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