ChemoSeed, a new implantable drug-delivery system, has received Orphan Drug Designation from the FDA for treating aggressive high-grade gliomas, including glioblastoma.
Traditional chemotherapy often struggles to reach brain tumors due to the blood-brain barrier. ChemoSeed overcomes this by using tiny biodegradable implants placed directly into the tumor or surgical site. These “seeds” release Irinotecan over time, targeting residual cancer cells where tumors often recur.
Glioblastoma remains highly lethal, with a median survival of just 14.6 months and a 5-year survival rate of 7%. ChemoSeed aims to improve outcomes by maintaining high drug concentrations at the surgical margin.
CRISM Therapeutics plans a Phase 2 registration-grade trial in the UK starting in early 2026. The study will test doses in recurrent GBM patients and later enroll 135 patients to evaluate progression-free and overall survival, with interim results expected in Q1 2027.
The FDA’s Orphan Drug status provides 7 years of US market exclusivity, tax credits for clinical trials, and fee waivers, supporting faster development and potential broader patient access.