DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, has announced its lead product, DNX-2401, has been designated by the European Commission as an Orphan medicinal product for the treatment of glioma. Glioblastoma, the deadliest form of glioma, strikes approximately 25,000 people a year in the U.S. and E.U.
Sponsors who obtain Orphan designation benefit from a number of incentives, including protocol assistance, scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market.
"We are pleased that the European Commission has recognized the potential benefits of our immunotherapy product for the treatment of brain tumors," said Frank Tufaro, Ph.D., CEO of DNAtrix. "We plan to continue our aggressive development program in the E.U."
DNX-2401 is an oncolytic adenovirus uniquely engineered to be safe and effective for the treatment of gliomas and other cancers. DNX-2401 has been evaluated in over 100 subjects with high grade gliomas in four clinical studies in the U.S. and E.U., with promising results.
The company recently completed enrollment in a phase Ib clinical study conducted in Spain for recurrent glioblastoma and plans to initiate a study for newly-diagnosed disease in Europe later this year. The company has previously been granted Orphan Drug designation for DNX-2401 in the U.S. for the treatment of glioma.