Tel Aviv Sourasky Medical Center is launching the first global Phase 2/3 clinical trial of SIL204, an investigational RNA-based therapy for pancreatic cancer developed by Israeli biotech firm Silexion Therapeutics.
The treatment uses small interfering RNA molecules to disable mutated KRAS genes within tumor cells. These mutations, which drive tumor growth, occur in approximately 90% of pancreatic cancer cases. Pancreatic cancer has a high mortality rate and is frequently detected only at advanced stages when surgical intervention is no longer viable.
The trial targets patients with locally advanced, unresectable pancreatic cancer. SIL204 will be injected directly into tumors to penetrate the dense stromal barrier that typically restricts drug delivery. Patients will receive the treatment alongside standard systemic chemotherapy, combining local and systemic approaches to address both primary tumors and potential metastatic spread.
Prof. Ravit Geva, who directs the Oncology Institute and Gastrointestinal Oncology Center at Sourasky Medical Center, is overseeing the study. "We are proud to be the first center worldwide to lead this Israeli-developed approach," She said.
The initial phase will recruit approximately 18 patients primarily to evaluate safety. Following positive results, the trial is expected to expand to additional centers in Israel, Germany and elsewhere, potentially involving up to 166 patients in total.
Silexion CEO Ilan Hadar described the launch as a significant milestone following years of research and development.
SIL204 is still under investigation, and its safety and efficacy remain to be established. The trial represents an emerging effort to address KRAS mutations, which have presented substantial obstacles in cancer treatment.