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.
Diverse Biotech is a US-based biopharmaceutical company, focused on medical discoveries and the development of new molecules for the treatment of cancer and other debilitating diseases.
Its focus is on discovering and developing novel therapeutics utilizing cannabidiol (CBD) as a core component and combining it through highly advanced chemistry with other molecules to develop new chemical entities that are theoretically more efficacious and less toxic.
The Company's initial focus is on hard-to-treat oncologic disorders including glioblastoma and pancreatic cancer, where targeted therapies have proven largely unsuccessful thus far and there is a significant unmet need.