On December 1, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the first patient has been treated in an investigator-sponsored pilot study of vosaroxin and cytarabine in adult patients age 60 years and older with previously untreated acute myeloid leukemia (AML) (Press release, Sunesis, DEC 1, 2015, View Source [SID1234508373]). The trial is being conducted at the Melvin and Bren Simon Cancer Center at Indiana University under the direction of Seyed Hamid Sayar, M.D., Assistant Professor of Clinical Medicine.

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"Achieving a complete remission with induction therapy is directly correlated with prolonged survival in the frontline treatment of AML," said Dr. Sayar. "Yet anthracyclines, a current backbone of induction therapy, are well known to be cardiotoxic, a toxicity that is of particular concern in older patients. New regimens, such as vosaroxin and cytarabine, with potentially less toxicity would be highly appealing not only in daily practice, but also to serve as a backbone for novel combinations."

The pilot efficacy assessment trial is expected to enroll approximately 17 previously untreated patients with AML who are age 60 and older who will receive up to 4 cycles of treatment (2 induction, 2 consolidation). Each 5-day cycle will include 10-minute infusions of vosaroxin (90mg/m2 for induction 1 and 70mg/m2 for subsequent cycles) on days 1 and 4, and 2-hour infusions of cytarabine (1g/m2) on days 1-5, followed by a variable interval required to achieve hematologic recovery (defined as absolute neutrophil count). The primary endpoint of the study is rate of complete remission, including complete remission with incomplete blood count recovery. Secondary objectives are safety of the combination in induction therapy of older patients previously unexposed to intensive chemotherapy, progression-free survival, length of stay in hospital for induction, and 30- and 60-day mortality rate.

"We are encouraged by the initiation of a new vosaroxin study in the frontline induction setting," said Daniel Swisher, Chief Executive Officer of Sunesis. "Vosaroxin is active and well tolerated in this population, both as a single agent, as seen in the REVEAL-1 study, and in combination with decitabine, as seen in our ongoing MD Anderson Cancer Center-sponsored study. We look forward to seeing results from these investigator-led studies, including data from the MD Anderson study later this year, while we continue to focus our internal resources on submitting our European Marketing Authorization Application for vosaroxin as a treatment for relapsed/refractory AML by the end of this year."

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 vosaroxin 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 vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin 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.