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March 8, 2018 – Silenseed, a leading company in targeted treatments for solid tumors, announced the recruitment of the first patient in the company’ SLSG12D-P2 Phase 2 clinical trial in Locally Advanced Pancreatic Cancer (LAPC). SLSG12D-P2 now is opened, recruiting eligible patients in the Memorial Sloan Kettering Cancer Center in New York, USA. Efficacy evaluations will include measurements of (CT- based) tumor response, survival status including overall survival and progression-free survival, CA 19-9 serum levels and CEA levels, Pain and Performance status. In addition, exploratory analyses and biomarkers in blood, urine and tissue samples will be studied, including circulating tumor cells, (CTC), circulating free DNA (cfDNA) and exosomes. Mutation analysis (including pancreatic cancer related mutations, including KRAS mutations) will be studied in biopsy samples, blood and urine samples and in cfDNA. For more information see here

March 7, 2018. Silenseed announced the publication of a new scientific paper named “Ammonium and arsenic trioxide are potent facilitators of oligonucleotide function when delivered by gymnosis”, by Xiaowei Zhang, Daniela Castanotto, Xueli Liu, Amotz Shemi and Cy A. Stein, in Nucleic Acids Research, 2018, 1. In this work, authors have identified ammoniumion (NH4+) as a non-toxic potent enhancer of oligonucleotide (ON) activity in the nucleus and cytoplasm. Enhancement of function can be found in attached and suspension cells, including in difficult-to-transfect Jurkat T and CEM T cells.

Feb. 26, 2018 – Silenseed announced today the allowance of USPTO Application number: 15/326044 RNA INTERFERENCE COMPOSITIONS TARGETING HEAT SHOCK PROTEIN 90 AND METHODS OF USE THEREOF (United States Patent Application 20170283803). The application 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. Hsp90  is a molecular chaperone that regulates the maturation, activation, and stability of critical signaling proteins that drive the development and progression of prostate cancer, including androgen receptor signaling.

Prostate adenocarcinoma, as a primarily endocrine disease, is frequently dependent (at least initially) on androgens to maintain growth and viability of the tumor. Androgen receptor, Akt and Her-2 (epidermal growth factor receptor) are all important pathways in prostate cancer and significantly, all are Hsp90 client proteins. Therefore, treatments that target Hsp90 would simultaneously disrupt multiple pathways in prostate cancer. Today (2017) about 10 Hsp90 inhibitors representing multiple drug classes, with different modes of action, are undergoing clinical evaluation.

 

Silenseed LTD, a clinical stage biopharmaceutical company developing targeted therapies for solid tumors, including pancreatic, prostate and brain tumors, will present at the Biotech Showcase 2018 event on Wednesday, January 10, 2018 at 11:45AM; Track: Franciscan – D (Ballroom Level), at the HILTON SAN FRANCISCO UNION SQUARE, San Francisco, CA, USA. Silenseed’s Chief Executive Officer, Dr. Amotz Shemi, will provide a corporate overview including the recent initiation of a Phase 2 clinical trial in pancreatic cancer, in about 10 U.S. medical centers, and the planned Phase 2a trial assessing efficacy of the company’s drug siG12D-LODER combined with Immune Oncology drugs.

 
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).

 

 

 

 

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)

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