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January 2, 2019 – Silenseed to present early Phase 2 clinical results in stage 3 pancreatic cancer. Presentation will include very preliminary clinical results from the first 11 patients enrolled in the company’ PROTACT Phase 2 clinical trial. Presentation will be given at the Biotech Showcase, the event claimed to be “The investor conference that drives the future of drug development”, at Wednesday, 11:00 AM January 9, 2019 Track: Franciscan C (Ballroom Level), Hilton Union Square San Francisco

 

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 KRAS-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.

 

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, KRAS-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 KRAS-LODER for treatment of pancreatic cancer.logo1c

“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