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Sunesis Pharmaceuticals Announces Late-Breaking Presentation Of Phase 3 VALOR Trial At ASH Annual Meeting


Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that results from the Company's Phase 3 VALOR trial of vosaroxin and cytarabine in patients with relapsed or refractory acute myeloid leukemia (AML) will be presented in a late-breaking oral presentation at the 56th American Society of Hematology Annual Meeting, taking place December 6-9 in San Francisco, California.

"We are very pleased that VALOR, the largest randomized company-sponsored trial ever conducted in relapsed or refractory AML, has been accepted as a late-breaking presentation at ASH," said Daniel Swisher, Chief Executive Officer of Sunesis. "Despite meaningful progress in other hematologic malignancies, relapsed refractory AML remains a disease where outcomes are unacceptably poor and drug therapy has changed little in the last forty years. We believe the results of VALOR demonstrate a clinically meaningful and important advancement in the treatment of this disease, and we appreciate the opportunity to share the full dataset with the medical community."

Details of the VALOR presentation and two related AML presentations at the ASH Annual Meeting are as follows:

VALOR Late-Breaking Oral Presentation (LBA-6)

Improved Survival in Patients with First Relapsed or Refractory Acute Myeloid Leukemia (AML) Treated with Vosaroxin Plus Cytarabine Versus Placebo Plus Cytarabine: Results of a Phase 3 Double-Blind Randomized Controlled Multinational Study (VALOR)
Presenter: Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center
Session: Late-Breaking Abstracts Session (7:30 AM - 9:00 AM)
Date: Tuesday, December 9, 2014, 8:45 AM
Room: Moscone Center, North Building, Hall D
Abstract Link:

MD Anderson Cancer Center Phase I/II Study Oral Presentation (385)

Title: Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
Presenter: Naval Daver, M.D., Assistant Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center
Session: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Drugs II (10:30 AM - 12:00 PM)
Date: Monday, December 8, 2014
Room: Moscone Center, South Building, Gateway Ballroom 103
Abstract Link:

Prevalence and Incidence of AML (958)

Title: Prevalence and Incidence of Acute Myeloid Leukemia May be Higher than Currently Accepted Estimates Among the ≥65 Year-Old Population in the United States
Presenter: Sean Turbeville, Ph.D., Sunesis
Session: Acute Myeloid Leukemia: Clinical Studies: Poster I (5:30 PM - 7:30 PM)
Date: Saturday, December 6, 2014
Room: Moscone Center, North Building, Hall E
Abstract Link:

About QINPREZO™ (vosaroxin)

QINPREZO™ (vosaroxin) is an 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.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

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