Jerusalem, January 26 2015 – Silenseed LTD announces the receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for KRAS-LODER for treatment of pancreatic cancer.
“The Orphan Drug designation of KRAS-LODER for the treatment of pancreatic cancer is Silenseed’s first RNAi-based treatment regulatory submission” said Dr. Amotz Shemi, CEO of Silenseed. “We’ve completed a successful Phase 1/2a trial in patients with locally advanced pancreatic cancer (LAPC). The results of the trial showed that KRAS-LODER is safe and well tolerated. Moreover, there were clear early evidences of an extended overall survival rate, the halting of tumor growth in all patients, and in most cases shrinkage of the tumor. With these encouraging outcomes we are preparing our multinational, randomized and controlled Phase 2/3 trial in LPAC, expected to start later this year (NCT01676259)”
FDA’s official Orphan Drug Designation and Approval