DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") announced the presentation of interim clinical data from the company's ongoing clinical trial with VAL-083 in refractory glioblastoma multiforme (GBM) during the Central Nervous System Tumor Session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held at the McCormick Place Convention Center in Chicago.
In summary, DelMar reported that:
- To date, one of two GBM patients in cohort 6 (30 mg/m2) exhibited stable disease after one cycle of treatment. Outcomes analysis of cohorts 6 and 7 are ongoing.
- No drug-related serious adverse events have been detected, and maximum tolerated dose (MTD) has not been reached at doses up to 30 mg/m2. Enrollment and evaluation of Cohort 7 (40mg/m2) is ongoing.
- Pharmacokinetics are linear and consistent with previous published data suggesting that concentrations of VAL-083 being obtained are effective against glioma cell lines in vitro.
In earlier cohorts, DelMar reported that two patients exhibited a response (stable disease or partial response) with a maximum response of 28 cycles (84 weeks) and improved clinical signs prior to discontinuing due to adverse events unrelated to study.
DelMar has also presented data demonstrating that the cytotoxic activity of VAL-083 is independent of MGMT, the enzyme believed to cause resistance to the current front-line therapy in the treatment of GBM.
If the MTD is not reached in cohort 7, DelMar would be prepared to file a protocol amendment with the FDA to allow dosing beyond 40mg/m2.
"We continue to be enthusiastic with the progress of VAL-083 as we advance toward doses which will be taken forward into registration-directed clinical trials," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "We believe that our data, combined with historical data from the National Cancer Institute demonstrating activity in the treatment of GBM, position VAL-083 as a promising new treatment option for GBM patients who have failed other available therapies."