Sunesis Pharmaceuticals Announces Initiation of Phase 2 Cohort of MD Anderson Sponsored Study of Vosaroxin in AML and High-Risk MDS
Expansion into the Phase 2 cohort follows the successful completion of a Phase 1b open-label, single-arm dose optimization phase which included six patients with previously untreated AML or high-risk MDS. Patients were treated with vosaroxin (90 mg/m2) intravenously on days one and four in combination with decitabine (20 mg/m2) on days one to five. The regimen was found to be well tolerated, with no dose-limiting toxicities, no early mortality and encouraging objective responses. Results, including data from the Phase 2 cohort, are expected to be presented at a medical conference in 2014.
"Older patients with AML or high-risk MDS are often intolerant or unresponsive to standard treatments," said Dr. Ravandi. "We find the tolerability and initial clinical activity in this first cohort of difficult-to-treat patients to be very encouraging and suggest important clinical potential for this combination. Based on these early data, we have designated the conduct of the Phase 2 component of this study a top priority."
Patients in the Phase 2 cohort will be followed for rate of remission, leukemia-free survival, overall survival and safety. The Phase 1b/2 study is expected to enroll up to a combined total of approximately 60 patients.
"We believe vosaroxin will have clinical utility in a number of different patient segments within AML and MDS," said
Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
MDS is a hematopoietic stem cell neoplasm that features dysplasia of the myeloid lineage. Hematopoiesis in these patients is disordered and ineffective. As the numbers and quality of blood-forming cells decline irreversibly, blood production is further impaired and patients often develop severe anemia requiring frequent blood transfusions. In most cases, the disease worsens and the patient develops neutropenia and thrombocytopenia caused by progressive bone marrow failure. In about one third of patients with MDS, the disease progresses into AML, usually within months to a few years.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the 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 the design, conduct, progress, timing and results of Sunesis' investigator sponsored trials, including Sunesis' vosaroxin related clinical programs, discussed in this release. Words such as "believe," "belief," "encourage," "estimate," "expect," "look forward to," "potential," "progress," "suggest," "will be," 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, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, 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, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, the risk that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin 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, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the
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