NORTH CHICAGO, Ill. , Oct. 23, 2024 /PRNewswire/ -- U.
P. Oncolytics, a company in Rosalind Franklin University's Helix 51 biomedical incubator, has been awarded Orphan Drug designation by the FDA's Office of Orphan Products Development for its oncolytic virus-based therapy to treat malignant glioma . Orphan diseases are rare conditions that affect fewer than 200,000 people in the U.
S. and are often serious or life-threatening. Orphan drug designation is given to drugs showing promise in treating, preventing or diagnosing orphan diseases.
"We are pleased by the FDA Orphan Drug designation," said U.P. Oncolytics CEO Dr.
Richard Rovin . "It, along with the SBIR (Small Business Innovation Research) grant, are strong validations of our science and our approach to bring new treatments to this highly resistant cancer." RFU announced on Sept.
30 that U.P. Oncolytics had earned a $500,000 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." Aimed at minimizing funding gaps, fast-track grants are awarded to projects that have a high potential for commercialization. About 80,000 people are newly diagnosed with primary brain tumors each year in the United States .
Approximately 25% of those tumors are gliomas. Gliomas form when glial cells grow out of control. They usually grow in the brain but can also form i.