Addressing the critical needs of pediatric cancers is an important part of Bexion’s clinical development strategy.
Diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG) are extremely rare pediatric brain tumors and present a treatment dilemma due to resistance to standard therapy (radiotherapy) and aggressive clinical course. DIPG primarily affects children, with most diagnoses occurring between 5 and 7 years of age. It makes up 10-15% of all brain tumors in children, with about 150-300 new diagnoses per year in the United States. Unfortunately, fewer than 10% of children survive two years from diagnosis.
Bexion Pharmaceuticals is committed to developing therapies to address the critical need in pediatric cancers. Bexion has received Orphan Drug status under the Orphan Drug Act for its proprietary drug, BXQ-350, for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG).
Additional Orphan Drug status benefits:
- Research grant eligibility for funding of Phase I and II Clinical Trials.
- Potential tax credits for certain research expenses.
- Waiver of FDA application user fees.
- Potentially faster regulatory process.