Business
Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced Pancreatic Cancer
Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed Application follows recent successful toxicology studies, positive German regulatory feedback, and strong preclinical data demonstrating up to 99.7% cancer cell inhibition Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in Grand Cayman, Cayman Islands, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Sil
About this update from Silexion Therapeutics Corp
[{"type":"image","alt":"Silexion Therapeutics Corp","displaySize":"","headline":null,"caption":"Silexion Therapeutics Corp","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":116,"url":"https://media.zenfs.com/en/globenewswire.com/0e108fa5d2c179a927ea7dc4257aea29"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dEbifqbuIRrs3yctodIWKw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE2MjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/0e108fa5d2c179a927ea7dc4257aea29","width":300,"height":116}},"lazy":false},{"type":"text","content":"Regulatory submission marks a significant milestone as the Company advances toward Phase 2/3 trial initiation in Q2 2026 at full speed","length":134,"tagName":"p"},{"type":"text","content":"Application follows recent successful toxicology studies, positive German regulatory feedback, and strong preclinical data demonstrating up to 99.7% cancer cell inhibition","length":171,"tagName":"p"},{"type":"text","content":"Regulatory filings in Germany and the EU are planned for Q1 2026, with U.S. expansion anticipated following the safety run-in","length":125,"tagName":"p"},{"type":"text","content":"Grand Cayman, Cayman Islands, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics, a clinical-stage biotechnology company advancing RNA-based therapies for oncology, today announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer (LAPC), based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices (BfArM).","length":482,"tagName":"p"},{"type":"text","content":"The submission represents a key regulatory milestone in the Company's clinical development program and advances Silexion toward initiating human trials with SIL204, which are planned for the second quarter of 2026. The application is further supported by two recently completed species toxicology studies confirming no systemic organ toxicity. Silexion plans to file regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated following completion of the safety run-in in Israel and Germany.","length":573,"tagName":"p"},{"type":"text","content":"The submissions in Israel are being conducted in collaboratio...