news

Oct 4., 2018 – Silenseed announced the new website pancan-protact.com for the ongoing Phase II study named PROTACT.  PROTACT, standing for Precise RNAi for Obtaining TArgeted Cancer Therapy, is an acronym that has been selected as for the Phase 2 SLSG12D-P2 study, in order to emphasize the power and hope behind the siG12D-LODER technology – very precise RNAi-based silencing of the well-known yet undruggable KRAS. Recently diagnosed patients with stage III pancreatic cancer can fill-in their details and see if are eligible and can join the trial.

September 6, 2018 – Silenseed announced that the Medical Centers Mount Sinai and Hackensack Meridian have joined Memorial Sloan Kettering and are now recruiting patients in the Phase 2 SLSG12D-P2 clinical trial in Locally Advanced Pancreatic Cancer (LAPC). Principle investigators in Mount Sinai are Celina Ang, MD and Christopher J DiMaio, MD; Principle investigators in Hackensack Meridiani are Martin E Gutierrez, MD and Rosario Ligresti, MD, FASGE.

 

 

Sep 2nd, 2018 – Cheli Gonnen is joining Silenseed as Vice President of Clinical Affairs. Gonnen will lead the company’s clinical development including the Phase 2 study (NCT01676259, now recruiting) in Locally Advanced Pancreatic Cancer (LAPC). Cheli is highly experienced in managing clinical trials in pharmaceutical and medical device companies. She brings to Silenseed her in-depth knowledge of all aspects of clinical trials at all stages. Previously Cheli served as the Clinical Trial Manager at OCON Medical Ltd., and at TCA Clinical Research. Before that Cheli served for about a decade as a Senior CRA in Merck Sharp & Dohme (MSD), covering phases I-IV in oncology and additional multiple therapeutic areas. Cheli received her M.Sc. in Biochemistry and Nutrition from the Hebrew University.

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)