FDA grants Orphan Drug Designation to DelMar’s VAL-083

FDA granted Orphan Drug Designation to VAL-083 in the treatment of ovarian cancer.

The investigational drug candidate, developed by DelMar Pharmaceuticals Inc., previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe.

In more than 40 phase I and II clinical studies sponsored by NCI, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

“We are pleased to receive the designation, which is timely in light of new data presented this week with supporting the potential for VAL-083 in the treatment of ovarian cancer,” said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. “This announcement is representative of the progress we’ve made in developing VAL-083 which we believe positions the therapy as a viable treatment option for ovarian cancer patients.”

DelMar’s collaborators from MD Anderson Cancer Center presented preclinical data at the annual meeting of the American Association for Cancer Research, demonstrating that VAL-083 appears to have a distinct mode of action from platinum-based chemotherapies widely used in the treatment of ovarian cancer. In these studies, VAL-083 demonstrated an ability to circumvent cisplatin-resistance in all ovarian cell lines tested.

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