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Del Mar Pharmaceuticals Granted U.S. Orphan Drug Designation for VAL-083 for the Treatment of Glioma

DelMar Pharma today announced that the United States FDA Office of Orphan Products Development has granted orphan drug designation for VAL-083 for the treatment of glioma, including glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

VAL-083 represents a 'first in class' small-molecule chemotherapeutic, which has been assessed in multiple NCI-sponsored clinical studies. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types, including GBM. DelMar Pharma has initiated a Phase I/II clinical trial of VAL-083 in patients with recurrent GBM, from which data is anticipated later this year.

"This orphan drug designation along with encouraging research results represents another important step in advancing this important new therapy to patients suffering from GBM," stated Jeffrey Bacha, DelMar Pharma's President & CEO. "The FDA's decision to grant orphan drug designation underscores the urgency of the need for new treatments for this life threatening cancer. We look forward to working cooperatively with the agency to advance this potentially important new therapy through the clinical trial and regulatory approval process."

The Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States. Among the benefits of orphan designation in the United States are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for clinical testing expenses conducted after orphan designation is received.

About DelMar Pharma

Del Mar Pharmaceuticals was founded in 2010 to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing modern targeted or biologic treatments. The Company's lead asset, VAL-083, benefits from extensive clinical research sponsored by the US National Cancer Institute, and is currently approved as a cancer chemotherapeutic overseas. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action.