FDA Grants DelMar Pharmaceuticals Orphan Drug Designation For VAL-083 In Ovarian Cancer

DelMar Pharmaceuticals (OTCQX:DMPI) announced today that the FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for its lead product candidate, VAL-083, in the treatment of ovarian cancer.  The investigational drug candidate previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Europe.
As quoted in the press release:

VAL-083 is a “first-in-class” small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, 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.
DelMar’s collaborators from the University of Texas MD Anderson Cancer Center (MD Anderson) presented preclinical data 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.

DelMar Pharmaceuticals Chairman and CEO, Jeffrey Bacha, stated:

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. 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.

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