Receives FDA Acceptance for Trademark Name Qinprezo™
- Continued progress of VALOR trial. Unblinding of the pivotal, Phase 3 VALOR trial of Qinprezo plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is expected in the third or fourth quarter of 2014, after reaching 562 events and locking the final study database. The updated guidance for unblinding of the trial reflects a slowing rate of events among the pool of patients in follow up.
- Announced data from ongoing MD Anderson Cancer Center-sponsored trial of Qinprezo and decitabine in frontline AML and high-risk MDS at AACR. In March 2014, Sunesis announced the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of Qinprezo in combination with decitabine in older patients with previously untreated AML and high-risk myelodysplastic syndrome (MDS). The combination of Qinprezo and decitabine showed robust clinical benefit and good tolerability in older patients with AML and high-risk MDS. The poster presented at the American Association for Cancer Research Annual Meeting 2014 (AACR), titled "Phase I/II study of vosaroxin and decitabine in older patients (pts) with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)," is available on the Sunesis website at www.sunesis.com .
- Announced updated data from MD Anderson Cancer Center-sponsored trial will be presented at ASCO 2014 Annual Meeting (Poster #383). Updated data from the ongoing MD Anderson Cancer Center-sponsored study will be presented at the 2014 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, Illinois. The poster titled "Phase I/II study of vosaroxin and decitabine in older patients with AML and high-risk MDS," will be presented at McCormick Place, S Hall A2, during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 2, 2014 from 1:15 p.m. to 5:00 p.m. Central Time.
- Appointed Chief Commercial Officer . In February 2014, Sunesis announced the appointment of Joseph I. DePinto to the newly created position of Executive Vice President and Chief Commercial Officer. Mr. DePinto brings over two decades of experience in global commercial operations, including the leadership of the commercial, marketing and strategic development efforts behind a number of prominent oncology products.
- Expanded oncology franchise through global licensing agreements with Biogen and Takeda/Millennium . In January 2014, Sunesis announced that it expanded its oncology franchise through separate global licensing agreements for two preclinical kinase inhibitor programs. The first agreement, with Biogen Idec, is for global commercial rights to SNS-062, a potent and selective non-covalently binding oral inhibitor of BTK (Bruton's tyrosine kinase). BTK is a mediator of B-cell receptor signaling, which is integral to the pathogenesis of B-cell malignancies. Sunesis anticipates filing an investigational new drug (IND) application for SNS-062 with the FDA within one year to begin human clinical trials.