DelMar is advancing its first-in-class brain cancer med dianhydrogalactitol (VAL-083) into phase 3, and it has recruited PRA Health Sciences to conduct that pivotal study.
The phase 3 trial, slated to start in June, will test the chemotherapy in recurrent glioblastoma multiforme (GBM) patients who have failed standard Temodar-Avastin treatments, an area where no currently approved therapy exists.
VAL-083, DelMar’s lead candidate, demonstrated clinical activity against several cancers in previous clinical trials sponsored by the U.S. National Cancer Institute. It has already nabbed an orphan drug designation in Europe for gliomas, and it has also received orphan designations from the FDA for glioma, medulloblastoma and ovarian cancer.
DelMar had been working with PRA for "quite some time" in preparing for the trial before the pair formally joined up, DelMar‘s chairman and CEO, Jeffrey Bacha, said in a statement. The new phase 3 trial will inherit the dosing regimen of 40 mg/m2/d on days one to three of a 21-day cycle, as determined in a phase 1/2 trial. The pair plans to enroll 180 patients and complete the study in August 2019.
Following guidance from the FDA, the Vancouver, Canada-based biopharma company—with the help of MD Anderson Cancer Center—started a phase 2 trial in January to test the drug in Avastin-naïve first recurrent glioblastoma patients.
The company is also collaborating with Sun Yat-sen University in China to test the medication as a first-line brain cancer treatment in phase 2. That 30-subject study is expected to start in June.
About 66% of GBM tumors demonstrate high expression of the MGMT promoter gene, and through its repair mechanism, those tumors can grow resistant to Temodar. In previous studies, VAL-083 has shown to be unaffected by the expression of MGMT, thus bearing the potential to become a new treatment option for patients who might be poor responders to Temodar.
As for PRA, at the end of April, the North Carolina-based CRO posted near 15% revenue growth for the first quarter of 2017, and the $427.1 million haul outperformed Wall Street’s previous expectations of a bit below $420 million. In addition, the company received new orders worth $564.8 million in that quarter.