Silexion Gains Unconditional BfArM Approval for Phase 2/3 SIL204 Pancreatic Cancer Trial
SLXN•Germany’s Federal Institute for Drugs and Medical Devices approved Silexion’s Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer, following Israel’s clearance and positive ethics opinion. First-patient dosing is expected within weeks across approximately 18-patient safety run-in sites in Germany and Israel, preceding a 166-patient expansion cohort.
1. German Approval Secured
The Bundesinstitut für Arzneimittel und Medizinprodukte granted unconditional approval under EU Regulation No. 536/2014 and the German Medicines Act to initiate Silexion’s Phase 2/3 SIL204 trial after the North Rhine Medical Association’s Ethics Committee issued a positive opinion, validating both Part I and Part II of the proposal.
2. Trial Initiation Plans
With approvals in Germany and Israel now in hand, Silexion is finalizing site activation procedures—including contracting and budget agreements—at major centers such as Sheba Medical Center, Tel Aviv Sourasky Medical Center and leading German oncology sites, aiming to dose the first patient in the coming weeks.
3. Study Design and Cohorts
The trial combines intratumoral and systemic administration of SIL204 alongside standard chemotherapy, beginning with an 18-patient safety run-in cohort and expanding into a randomized 166-patient cohort to assess efficacy and safety in locally advanced pancreatic cancer.
4. Regulatory Strategy and Expansion
Following Israel’s March authorization, Germany’s role as Reporting Member State under the CTIS framework streamlines potential expansion into additional EU member states, positioning Silexion to leverage harmonized assessments and broader site activation for its Phase 2/3 program.
