FDA grants orphan drug status to BXQ-350 for treatment of glioblastoma multiforme
The FDA granted orphan drug designation to BXQ-350, an agent in development for treatment of glioblastoma multiforme.
BXQ-350 (Bexion Pharmaceuticals) is a proprietary nanovesicle formulation of sphingolipid activator protein C, or Saposin C, and the phospholipid dioleoylphosphatidylserine.
“Orphan drug status for BXQ-350 is an important milestone in the development of this new treatment modality,” Ray Takigiku, PhD, founder and CEO of Bexion Pharmaceuticals, said in a press release. “Few treatment options are available for patients suffering from glioblastoma multiforme, and this designation recognizes the unmet need that exists with this disease, as well as the unique attributes of BXQ-350. In addition, orphan designation allows Bexion to benefit from important financial, regulatory and commercial considerations, and we have seen recently that products with orphan designation have become sought-after assets.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
Bexion Pharmaceuticals previously received a Phase II Bridge Award from the NCI to support the manufacture and clinical testing of BXQ-350.