U.P. Oncolytics, a company in Chicago-based Rosalind Franklin University's (RFUs) Helix 51 biomedical incubator, announced on Wednesday that the FDA's Office of Orphan Products Development has granted Orphan Drug designation to the company's oncolytic virus-based therapy to treat malignant glioma.
RFU announced on 30 September that U.P. Oncolytics had earned a USD500,000 NIH award as part of a Phase I-Phase II SBIR Fast-Track grant. The award will fund the company's proposed in vitro and in vivo IND-enabling studies on the 'Validation of a novel treatment for glioblastoma using oncolytic Zika virus.'
RFU Interim VP for Research and Dean of the School of Graduate and Postdoctoral Studies Joseph DiMario, PhD, stated that the orphan designation represents an important milestone in the development of UP Oncolytic's drug candidate.
UP Oncolytics CEO Dr Richard Rovin, said, 'UP Oncolytics' progress in developing this novel therapy for GBM brings new hope to patients and their families suffering from this terrible disease. We are greatly encouraged by their development plans and recognition by key regulatory and scientific authorities.'
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