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  • ||||||||||  Clinical, Review, Journal:  Efficacy and safety of drugs for nonalcoholic steatohepatitis. (Pubmed Central) -  Sep 19, 2021   
    Vitamin E has been recommended for patients with NASH without type 2 diabetes mellitus (T2DM), whereas a combination of pioglitazone and vitamin E is recommended for patients with both NASH and T2DM...Some of the drugs are at phase III clinical trials, including obeticholic acid (OCA), Elafibranor, Cenicriviroc, Selonsertib, Resmetirom, Emricasan and Aramchol...Especially, due to the interim positive effect for the improvement of liver fibrosis, OCA has been filling to FDA and is waiting for the final approval for the treatment of NASH. Therefore, it is urgent to review the efficacy and safety of drugs for NASH in current clinical trials.
  • ||||||||||  Journal:  Nonalcoholic Fatty Liver Disease: A Drug Revolution Is Coming. (Pubmed Central) -  Sep 11, 2021   
    Five pharmacologic agents-obeticholic acid, elafibranor, cenicriviroc, resmetirom, and aramchol-are being evaluated in large, histology-based phase 3 trials...Based on the results of phase 2 and 3 trials, combination treatments are also being investigated. Future treatment strategies will comprise drug combinations and precision medicine based on the different phenotypes of NASH and treatment response of the individual patient.
  • ||||||||||  Journal:  New drugs for non-alcoholic steatohepatitis and HIV infection: great expectations with a great absent? (Pubmed Central) -  Apr 21, 2021   
    The risk of DDI between ART and aramchol, cenicriviroc, elafibranor, obeticholic acid and resmetirom (MGL-3196), which are currently in phase III trials for the treatment of NASH, are reviewed. Finally, a model for trial design to include PLWH is proposed, strongly advocating for the scientific community to include this group as a sub-population within studies.
  • ||||||||||  anti-PD-1 antibody / Tikcro Technologies
    [VIRTUAL] Characterization of molecular and spatial diversity of macrophages in hepatocellular carcinoma (Channel 03) -  Mar 11, 2021 - Abstract #AACR2021AACR_2729;    
    P2
    Taken together, our data provide a new understanding of intratumoral MΦ diversity and highlight the presence of specific immunoregulatory MΦ programs unique to tumor lesions, with subsets of these MΦ found to be directly interacting with T cells, potentially modulating anti-tumor responsiveness. Our analysis of resected tumor from anti-PD-1 treated patients, will allow us to correlate MΦ programs, and direct T cell interaction, with clinical response, and will inform therapeutic trials targeting specific MΦ populations so as to improve clinical efficacy of cancer immunotherapy.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), anti-PD-1 antibody / Tikcro Technologies
    [VIRTUAL] The recently approved high-TMB criteria may introduce a sex bias in response to PD1 inhibitors (Channel 04) -  Mar 11, 2021 - Abstract #AACR2021AACR_827;    
    The FDA-approved criteria of 10 mutations/Mb could serve as an informative biomarker for stratifying female melanoma patients but is inadequate for stratifying male patients for anti-PD1 treatment. Our results indicate that its usage is likely to introduce a sex bias in additional cancer types, which will be highly important to carefully test further in larger datasets.
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion date, Trial primary completion date:  A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (clinicaltrials.gov) -  Feb 17, 2021   
    P3,  N=2000, Recruiting, 
    Our results indicate that its usage is likely to introduce a sex bias in additional cancer types, which will be highly important to carefully test further in larger datasets. Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Jun 2022 --> Dec 2024
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion date, Trial primary completion date:  Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment (clinicaltrials.gov) -  Feb 9, 2021   
    P1,  N=56, Enrolling by invitation, 
    Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Jun 2022 --> Dec 2024 Trial completion date: Jan 2021 --> Jul 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
  • ||||||||||  [VIRTUAL] Non-Alcoholic Steatohepatitis (NASH) Drug Pipeline Report September 2020 () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2853;    
    Due to the complexity of NASH pathophysiology, whether combinations of drugs may improve efficacy over single agents still remains to be studied. Currently available non-histological biomarkers have not consistently shown enough correlation to replace histological endpoints within clinical trials.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    [VIRTUAL] Aramchol improves glucose and lipid homeostasis in NASH via regulation of AMPK and mTOR (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-987;    
    Our study shows that hepatocytes respond to Aramchol treatment by activating AMPK and inhibiting mTORC1, which in turn activate FA β-oxidation and oxidative phosphorylation inhibiting de novo lipogenesis, gluconeogenesis and cataplerosis. These results offer a possible explanation for downregulation of HbA1c as well as for the reduction in hepatic TG observed in NASH patients treated with Aramchol.
  • ||||||||||  Review, Journal:  What is the (right) target for non-alcoholic fatty liver disease (NAFLD)? (Pubmed Central) -  Jan 22, 2020   
    A number of phase 3 clinical trials are currently ongoing including Elafibranor, a dual PPAR α/δ agonist, Cenicriviroc, a CCR2/CCR5 chemokine antagonist, the nuclear bile acid receptor FXR agonist obeticholic acid, Aramchol, a fatty acid bile acid conjugate that modulates SCD-1, and Resmetrion, a liver-specific THR-β agonist...the ASK-1 inhibitor Selonsertib or the caspase inhibitor Emricasan have shown negative results...The complex pathophysiology of the disease, which combines inflammation, metabolism and fibrosis, has led to the fact that even combinations of several substances are investigated with different modes of action. This review summarizes pivotal clinical trials for patients with NASH in the absence of cirrhosis which are recruiting in the fall of 2019.
  • ||||||||||  Review, Journal:  Current and future pharmacological therapies for NAFLD/NASH. (Pubmed Central) -  Oct 9, 2019   
    Among a variety of medications in development, four agents such as OCA, elafibranor, ASK1 inhibitor, and CVC are currently being evaluated in an international phase 3 trial for the treatment of NASH. Within the next few years, the availability of therapeutic options for NASH will hopefully curb the rising trend of NASH-related diseases.
  • ||||||||||  CTLA4 inhibitor antibody therapeutic / Tikcro Technologies
    Single cell analysis reveals the pivotal role of the innate immune compartment in aCTLA-4 anti-tumor response. () -  Oct 4, 2019 - Abstract #CRICIMTEATIAACR2019CRI-CIMT-EATI-AACR_119;    
    Finally, a vast tissue repair signature was observed in later time points of aCTLA4 mIgG2a treatment, comprised of MRC1+ macrophages, neutrophils, and myeloid-derived suppressor cells (MDSCs), while CD8 T cell abundance declined. In summary, our findings provide an in-depth view of the differences in mechanisms of action between an aCTLA4 blocking mAb, and an optimized blocking-depleting mAb, emphasizing how FcgRs co-engagement leads to enhanced anti-tumor response via the innate immune compartment.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed Medical Research, Weizmann Institute of Science
    ARAMCHOL, SCD1 INHIBITOR, IMPROVES LIVER GLUCOSE HOMEOSTASIS IN NASH (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2898;    
    These results suggest that Aramchol targets not only the alterations in lipid metabolism that characterize NASH but additionally improves liver glucose homeostasis in patients and murine models. Also, in Aramchol-treated primary hepatocytes, there is an inhibition in LPC and GPC formation, which would improve VLDL-TG secretion, together with a reduction in TCA cycle metabolites.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed Medical Research, Weizmann Institute of Science
    INCREASED EXPOSURE OF ARAMCHOL BY USING A SPLIT DOSE – POTENTIAL FOR GREATER EFFICACY IN NASH (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_1901;    
    The prediction from the PK model was born out with substantially higher concentrations of Aramchol obtained with twice daily regimen. Based on the ARREST study and dose dependency pattern, this increase in exposure offers the potential for greater efficacy in the treatment of NASH with Aramchol.
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion:  Comparison of Aramchol Concentrations With Once or Twice Daily Dosing (clinicaltrials.gov) -  Apr 4, 2019   
    P1,  N=16, Completed, 
    Based on the ARREST study and dose dependency pattern, this increase in exposure offers the potential for greater efficacy in the treatment of NASH with Aramchol. Recruiting --> Completed