Diverse Biotech gets orphan-drug designation from USFDA for investigational new therapies in glioblastoma

Doylestown: Diverse Biotech, Inc. has announced the U.S. Food & Drug Administration (FDA) has granted an orphan drug designation request for one of its investigational new therapies for the treatment of newly diagnosed glioblastoma, in conjunction with standard treatment, following adjuvant combined chemo-radiation.

Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, (Orphan Drug Act) including tax credits for qualified clinical testing. For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria.

"We are very excited about the FDA orphan-drug designation for an investigational therapy the company is currently researching. Glioblastoma is a devastating disease with very low 5-year survival rates. The orphan drug designation helps Diverse Biotech to advance our program, designed to combat such a terrible disease, and potentially improve the survival rates. We are committed to developing unique and powerful new medicines to help patients with diseases where there may be limited treatment alternatives. Our aspiration is to develop new drugs to change the standards of care in different diseases starting with glioblastoma," said Stella Vnook, Diverse Biotech's Chief Executive Officer.