Re: Farmas USA
At the time of the analysis, 75% of patients treated with VAL-083 had survived longer than predicted following failure of bevacizumab therapy with supportive care and 48% of patients treated with VAL-083 survived longer than predicted following failure of bevacizumab and subsequent treatment with a range of salvage therapies.
Sakruti et al. (2014) reported that the median OS from the start of bevacizumab was 12.2 months (95% CI, 10.0, 14.3) with no significant difference in OS whether bevacizumab therapy was initiated following first, second or later GBM recurrence.
At the time of the analysis, 59% of patients treated with VAL-083 survived longer than predicted following initiation of bevacizumab therapy.
In the Phase I/II study of dianhydrogalactitol in patients with recurrent malignant glioma, at the time of the analysis:
6 month OS following initiation of VAL-083 treatment across all dose cohorts was 41.4%, with two additional patients from later cohorts still alive, but not yet reaching 6 month OS.
12 month OS following initiation of VAL-083 treatment across all dose cohorts was 17.2%, with four additional patients from later cohorts still alive, but not yet reaching 12 month OS.
Median OS for refractory GBM patients receiving VAL-083 at doses >30mg/m2 was approximately 9.0 months offering the potential of meaningful survival benefit in this patient population compared to other available treatment options.
Doses in DelMar's clinical trial exceed those utilized in prior NCI-sponsored clinical trials with VAL-083 in GBM.
DMPI
