On October 15, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that data from the company’s VALOR trial evaluating vosaroxin in older patients with acute myeloid leukemia (AML) will be presented at the AML Clinical Trial Oral Session of the 77th Annual Meeting of the Japanese Society of Hematology (JSH), taking place in Kanazawa, Japan (Press release, Sunesis, OCT 15, 2015, View Source;p=RssLanding&cat=news&id=2097654 [SID:1234507723]). The results are being presented Friday, October 16th at 8:30 a.m. Japanese Standard Time by Robert Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina.
The presentation (Abstract OS-1-82), titled "Patients Age ≥60 Yrs With First Relapsed/Refractory AML Treated With Vosaroxin/Cytarabine vs Placebo/Cytarabine," will be the first presentation in the session, which will take place in Session Room 15 (Emerald A) in Hotel Kanazawa 4F. Detailed results of the VALOR trial were presented in the "Late Breaking Abstracts" session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2014. The data presented today at the JSH Annual Meeting were first presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2015.
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"Globally, patients with relapsed or refractory AML are highly underserved, particularly older patients whose prognoses are far poorer," said Shuichi Miyawaki, MD, PhD., Division of Hematology, Tokyo Metropolitan Ohtsuka Hospital, and former vice-president of the Japan Adult Leukemia Study Group. "As in the U.S. and Europe, treatment standards in Japan have not changed significantly in the past several decades. The data from VALOR in patients age 60 years and older show a compelling survival benefit, durable responses and tolerability profile that strongly support the potential for the vosaroxin/cytarabine combination as an important new treatment option for this highly underserved population."
Sunesis recently announced that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for patients age 60 years and older with relapsed/refractory AML with the European Medicine Agency (EMA) by the end of 2015.
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.
About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.