Sunesis Initiates Investigator-Sponsored Phase I/II Trial Of Vosaroxin

(RTTNews) - Sunesis Pharmaceuticals, Inc. (SNSS) Monday said it started the Phase I/II investigator-sponsored trial of vosaroxin, in adult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome or MDS. Vosaroxin is an anti-cancer quinolone derivative, a class of compounds that has not been used previously for the treatment of cancer.

The Phase I/II, open-label, dose escalating trial is expected to enroll up to about 40 partients with MDS, who have previously failed treatment with hypomethylating agent-based therapy. The patients will at first receive escalating doses of vosaroxin over each 28 day treatment cycle. After the maximum tolerated dose or MTD is found, an expanded evaluation of safety and hematologic response or improvement rate at this dose level will be conducted in additional subjects, so that the total number of subjects exposed to this dose level increases to up to 15 subjects. Along with the MTD and dose limiting toxicity, study endpoints include rate of complete remission, partial remission, hematologic improvement and blood transfusion requirements.