BfArM Approval to Initiate Ph 2/3 Trial of SIL204 in Locally Advanced Pancreatic Cancer
“With this BfArM approval, Silexion has now secured clinical trial authorizations in the two leading regulatory jurisdictions where we sought to initiate the Phase 2/3 trial of SIL204,” said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. “Germany is widely regarded as one of the most rigorous regulatory environments globally, and an unconditional approval as Reporting Member State under the EU Clinical Trials Regulation is, for us, a strong external validation of the SIL204 preclinical and safety package and a meaningful endorsement of the trial design we developed in close engagement with the agency. With Israeli and German authorizations now in hand, our focus shifts entirely to clinical execution, and we expect to dose our first patient in the coming weeks at one of the activated sites in Israel or Germany.”
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