DelMar Pharmaceuticals Inc. announced a protocol amendment to allow for expanded dosing in its VAL-083 clinical trial had been filed with the U.S. Food and Drug Administration (FDA) and that a new cohort of a new 50mg/m2 has been opened at three clinical trial sites in the United States. One of three glioblastoma multiforme (GBM) patients in the most recent (40mg/m2) cohort and one of three GBM patients in the previous (30mg/m2) cohort exhibited stable disease after one or two cycles of treatment with VAL-083. No drug-related serious adverse events or dose limiting toxicities (DLTs) have been detected and a maximum tolerated dose (MTD) has not been reached at doses up to 40 mg/m2.
The company plans to present detailed results at scientific meetings during the second half of 2014.
Jeffrey Bacha, president and CEO of DelMar stated, “Patients being enrolled in our current clinical trial have a growing brain tumor that has failed to respond to any other approved treatment. The correlation between tumor progression and death in this patient population is well documented; therefore, our interim results demonstrating that, in some patients at doses studied to date, VAL-083 can either stabilize disease progression by halting tumor growth (as measured by RANO criteria) or shrink the tumor is expected to result in longer patient survival and improved quality of life. We anticipate enhanced response rates as we progress to higher doses and keep patients on treatment longer during future registration-directed clinical trials.”
VAL-083 is a first-in-class small molecule chemotherapy that was studied in previous clinical trials sponsored by the U.S. National Cancer Institutes (NCI). In NCI-sponsored clinical trials, VAL-083 demonstrated activity against a range of tumor types, including GBM. DelMar’s data suggest that the tumor-killing mechanism of VAL-083 is distinct from other chemotherapies approved for the treatment of GBM and therefore are not subject to resistance by mechanisms such as MGMT, which are believed to cause the majority of patients to fail chemotherapies available for treatment today.
DelMar plans to advance clinical trials with VAL-083 as a potential treatment for GBM patients who have failed therapy with both Temodar and Avastin. Currently, there is no available or approved therapy for these patients and their prognosis is very poor with a life expectancy of only weeks to months.
Date: August 19, 2014
Source: Delmar
Filed Under: Drug Discovery