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news.The US Food and Drug Administrations' Office of Orphan Products Development has granted orphan drug designation for DelMar Pharma's VAL-083, used to treat glioma, including glioblastoma multiforme (GBM).
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Earlier pre-clinical and clinical data suggested that VAL-083 may be active against a range of tumor types, including GBM.
DelMar Pharma president and CEO Jeffrey Bacha said the FDA’s decision to grant orphan drug designation highlights 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," Bacha added.
The company has begun a Phase I/II clinical trial of VAL-083 in patients with recurrent GBM, and the results are likely to be announced later this year.