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July 20, 2017, Modi’in – Silenseed announced the FDA approval of IND (Investigational New Drug) for Phase 2 Clinical Trial of siG12D-LODER in the Treatment of Patients with Unresectable Locally Advanced Pancreatic Cancer

The trial is planned as a Prospective, Multinational, Multi-center, Phase 2, Randomized, Controlled, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of siG12D-LODER in the Treatment of Patients with Unresectable Locally Advanced Pancreatic Cancer (LAPC) when used in Conjunction with Standard Chemotherapy (NCT01676259).

 

 

 

 

Non-clinical early signs on the potential of RNAi + IO combination: Silenseed to present in the “Annual Cancer Immunotherapy Summit” conference, November 21-22 2016, Berlin, (Title: RNAi And Immunotherapy – The Case Of Pancreatic Cancer); and in the “8th annual Conference on RNA Therapeutics 2017″, February 22-23, 2017, London (Title: RNAi and tumor microenvironment: pre-clinical and clinical evidence)

Silenseed, a leading RNAi-based therapeutics company, announced today (May 4, 2016) the publication of “Preclinical Safety Evaluation in Rats of a Polymeric Matrix Containing an siRNA Drug Used as a Local and Prolonged Delivery System for Pancreatic Cancer Therapy” Ramot Y, Rotkopf S, Gabai RM, Khvalevsky EZ, Muravnik S, Marzoli GA, Domb AJ, Shemi A, Nyska A.Toxicol Pathol. 2016 May 4. pii: 0192623316645860

Silenseed, a leading RNAi-based therapeutics company, announced today (February 1, 2016) the new company’s PCT application WO/2016/009428, named “RNA INTERFERENCE COMPOSITIONS TARGETING HEAT SHOCK PROTEIN 90 AND METHODS OF USE THEREOF”. This disclosure relates to RNA interference (RNAi) compositions that target expression of heat shock protein 90 (HSP90) in a subject. Polymeric delivery devices for providing the RNAi compositions are also described, as are methods of treating cancer using the described RNAi compositions.

Modi’in, Israel, Dec. 31, 2015 – Silenseed, a leading RNAi-based therapeutics company, today announced the construction of a class-A GMP clean room facility in the new company office Modi’in. The new facility will enable in-house production of the company’s lead product, siG12D-LODER, to support the Phase 2 study in Locally Advanced Pancreatic Cancer (NCT01676259)

Silenseed, a leading RNAi-based therapeutics company, announced (July 14, 2015) that the United States Patent and Trademark Office (USPTO) has issued a new patent (U.S. patent no. 9,080,173) named “Methods and compositions for RNAi-based cancer treatment”” to be added to the company’s fast growing patent estate. Specifically, the patent describes the composition of matter of RNAi (RNA interference) agents for treating a patient having a solid tumor expressing a mutated K-ras protein. This is a divisional of U.S. patent application of the same name, Ser. No. 13/451,231, filed on Apr. 19, 2012.

Jerusalem, January 26 2015 – Silenseed LTD announces the receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for siG12D-LODER for treatment of pancreatic cancer.logo1c

“The Orphan Drug designation of siG12D-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 siG12D-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