Sunesis Pharmaceuticals Announces Initiation of an Investigator-Sponsored Trial Evaluating Vosaroxin in Combination With Azacitidine in MDS
"Additional therapeutic options are needed for patients with MDS," said Dr. Jacoby. "While azacitidine has been shown to improve survival in patients with high-risk MDS, existing therapies do not produce a remission in the majority of patients and are not curative. Given its clinical profile, we believe that investigation of vosaroxin's activity in high-risk MDS is warranted."
The Phase 1/2, open label, dose-escalation trial will enroll up to approximately 40 patients with MDS who may have received up to three prior cycles of hypomethylating agent-based therapy. Patients will receive vosaroxin (days one and four) and azacitidine (days one through seven) for a maximum of six cycles. This dose escalation study is designed to enroll six patients per cohort in order to determine the maximum tolerated dose (MTD) and dose limiting toxicity of the combination. Other endpoints include best response, safety, tolerability, and event-free, progression-free, disease-free and overall survival. Once the MTD is determined, up to an additional 20 patients will be enrolled, treated and evaluated at that dose level.
"We are pleased that vosaroxin continues to receive a great deal of interest from the oncology community. With the initiation of this trial, vosaroxin is now being studied in three investigator-sponsored trials at leading U.S. medical research centers," said
Sunesis also announced today that it has been informed that the
Dr. Craig added: "While not unexpected, we are disappointed by outcomes in the LI-1 trial and, as with the single agent vosaroxin arm in this study, believe that investigator familiarity and adequate supportive care are critical factors in achieving positive clinical benefit in a frail, elderly population. We remain confident in vosaroxin's potential in the elderly AML population, which we continue to explore through investigator-sponsored studies at leading institutions."
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
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 MDS 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 of initial diagnosis.
According to the
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 the VALOR trial and Sunesis' investigator sponsored trials, including Sunesis' vosaroxin related clinical programs, discussed in this release. Words such as "continues," "expect," "look forward," "need," "potential," "provide," "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, 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
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717