Vancouver-based DelMar Pharmaceuticals (BC) Ltd. announced this morning it has received approval from the U.S. Food and Drug Administration (FDA) to launch clinical trials of brain cancer drug VAL-083.
DelMar president and CEO Jeffrey Bacha explained the drug was developed 20 years ago by the National Cancer Institute (NCI) in the United States and has been commercialized in China.
According to the company, pre-clinical and clinical studies sponsored by the NCI suggest that VAL-083 may be able to treat a range of tumour types, including glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
Bacha said FDA approval of a clinical dosage trial is “huge” for the company.
“It’s a big step for us to be able to be able to move forward in a clinic and show that the drug works the same way it did 20 years ago and hopefully move very quickly and be able to offer something new to patients that currently have nothing available to them,” he said.
Bacha said that, for approximately half of patients diagnosed with GBM, no current drugs available in the United States will work.
The clinical trial is slated to occur at the Sarah Cannon Research Institute in Nashville, Tennessee. Bacha said the company is doing trials in the U.S. because that’s where it can access a base of patients who have failed drug therapies Temodar and Avastin. Avastin is not widely used in Canada.
Bacha said the company is hoping to see the trial launched in the fall, pending the completion of a round of financing. From there, he said he hopes to see the first trial complete within approximately a year, with enrolments complete for a registration trial in one to two years.
That three-year timeline, he said, reflects the company’s ability to leverage the drug’s history of being studied by the NCI and its overseas commercialization to accelerate the drug’s commercialization in North America.
“A company that starts with a university discovery is looking 10 years out. So we’re in a much more rapid position.”
Jenny Wagler
Twitter: JennyWagler_BIV