Sunesis Pharmaceuticals Announces First Patient Treated in Indiana University Pilot Study of Vosaroxin and Cytarabine in Adults Age 60 Years and Older With Previously Untreated AML
"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
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
The trademark name QINPREZO is conditionally accepted by the
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 advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
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This press release contains forward-looking statements, including statements related to Sunesis' estimated timelines for regulatory interactions and regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA and plans to gain marketing approval of vosaroxin in the U.S., Sunesis' overall strategy, the design, conduct and results of clinical trials, including the expected progress in its kinase inhibitor pipeline, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis' clinical development of vosaroxin, including the analysis of the results from the VALOR clinical trial. Words such as "anticipates," "estimates," "expect," "intends," "plan," "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 submit timely the MAA to the EMA, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or
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David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717