To get good news, we have to rejoice in the lots of little positive announcements along the way. At first, when I read Sunesis' press release about the enrollment completion, I wanted to yawn.
But, then I was reminded, that if enrollment wasn't complete, then nothing could be learned. So...here is some potentially good news down the road:
Sunesis Pharmaceuticals, Inc. announced today that it has completed enrollment in its Phase 1b/2 clinical trial evaluating voreloxin, the company's lead compound, in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory acute myeloid leukemia (AML).
A total of 110 patients with relapsed or refractory AML were enrolled in this study, including 50 primary refractory or first relapse AML patients enrolled in the expansion Phase 2 segments of the trial.
"Full enrollment of this trial marks an important step in our development of voreloxin in AML, a disease in which we plan to begin Phase 3 clinical testing later this year," said Daniel Swisher, Chief Executive Officer of Sunesis. "The Phase 1b/2 combination trial has already generated valuable data regarding voreloxin's anti-leukemic activity, including low 30- and 60-day all-cause mortality and favorable complete remission, safety and preliminary survival results in a difficult to treat patient population.”
The Phase 1b/2 trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered on days one and four with cytarabine, given either as a continuous infusion of 400 mg/m2 daily for five days or as a two hour IV bolus of 1 g/m2 daily for five days. A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified based on results of the Phase 1b/2 clinical trial to date.
