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DMPI

DelMar Pharmaceuticals

$1.77

0.125 (7.60%)

14:16
05/31/19
05/31
14:16
05/31/19
14:16

DelMar Pharmaceuticals announces clinical updates presented at ASCO

In a regulatory filing, DelMar Pharmaceuticals reported that the company presented clinical updates on May 31 from the company's ongoing first- and second-line trials in patients with MGMT-unmethylated glioblastoma multiforme at a key opinion leader presentation during the 2019 American Society of Clinical Oncology, or ASCO, annual meeting. At the KOL presentation, the company provided an update on the ongoing Phase 2 clinical study investigating the front line treatment of VAL-083 with radiation therapy in newly diagnosed MGMT-unmethylated GBM. As of May 17, eighteen patients have been enrolled in the trial. Of these patients, fifteen have received their post-cycle 3 MRI and investigator assessment, and ten have received their post-cycle 7 MRI and investigator assessment. Two patients have not been on the study long enough to reach their first assessment, and one patient died before their first assessment. Assessments are based on the trial investigator's clinical and radiologic assessment, according to the Response Assessment in NeuroOncology criteria. For the fifteen patients who have received at least one assessment, eight patients were assessed with a best response of "Complete Response" and seven patients were assessed with a best response of "Stable Disease". Fourteen of the eighteen patients were still alive at the data cut-off date. The company also provided an update on the ongoing second-line Phase 2 clinical study of VAL-083 in patients with MGMT-unmethylated, Bevacizumab-naive recurrent GBM. As of May 5, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m2, and 16 patients at a starting dose of 30 mg/m2. For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI: 9/35 patients initially receiving 40 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2; 4/12 patients initially receiving 30 mg/m2 exhibited "Stable Disease" per investigator assessment at the end of cycle 2. Additionally, the study protocol has been amended to include enrollment of up to 24 newly-diagnosed GBM patients who have completed chemoradiation treatment with TMZ and received no subsequent TMZ maintenance therapy but will receive VAL-083 instead. This Group has been included to explore whether earlier intervention with VAL-083 instead of TMZ maintenance therapy offers clinical benefit and extends the time to recurrence as compared to TMZ maintenance therapy. Consistent with prior studies, myelosuppression is the most common adverse event in both ongoing clinical trials, the company stated in the filing.

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