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  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Biomarker, Clinical, Journal:  Remodeling of immunological biomarkers in patients with chronic hepatitis C treated with direct-acting antiviral therapy. (Pubmed Central) -  Dec 16, 2021   
    We sought to analyze the kinetics profiles of serum biomarkers (LuminexTM) in fifty patients with chronic hepatitis C enrolled in a longitudinal investigation carried out before (baseline), during (W2-4 and W8-12 weeks) and post-treatment (W12-24 weeks) with sofosbuvir plus daclatasvir or simeprevir...High ALT (>69U/L), low platelet (≤150,000/mm) and cirrhosis status at baseline were factors related to delayed immune response shift, as well as, in the kinetics of baseline fold changes in serum biomarkers. These findings added novel evidences for the immunological restoration process triggered by DAAs.
  • ||||||||||  Rexulti (brexpiprazole) / Lundbeck, Otsuka
    Review, Journal:  New Antipsychotic Medications in the Last Decade. (Pubmed Central) -  Dec 16, 2021   
    We identified 11 significant developments: the introduction of new antipsychotics cariprazine, brexpiprazole, lumateperone, and pimavanserin; introduction of new delivery subcutaneous long-acting risperidone, aripiprazole lauroxil, transdermal asenapine, and inhaled loxapine; and the introduction of new approaches such as olanzapine/samidorphan for olanzapine-associated weight gain, examination of the TAAR1 agonist SEP 363,856 as a test of concept, and the combination of Xanomeline/Trospium, an M and M muscarinic receptor agonist in conjunction with a peripheral anticholinergic. Last decade has seen a tremendous development in second-generation antipsychotics which provides unprecedented treatment options for clinicians in treating psychosis.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Journal, PD(L)-1 Biomarker, IO biomarker:  A nanodrug incorporating siRNA PD-L1 and Birinapant for enhancing tumor immunotherapy. (Pubmed Central) -  Nov 29, 2021   
    In addition, Birinapant could inhibit tumor growth via increasing the secretion of and the sensitivity to TNF-α in a TNBC xenotransplantation mouse model. Consequently, liposomes encapsulating Birinapant and siPD-L1 mediated a form of combination therapy based on two drugs to significantly increase the therapeutic effects toward TNBC.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Journal:  Targeting triple-negative breast cancers with the Smac-mimetic birinapant. (Pubmed Central) -  Nov 10, 2021   
    In addition, the cell death complex was preferentially formed in TNBCs versus ER cells in response to Smac mimetics. Taken together, our findings provide a rationale for prospectively selecting patients whose breast tumors contain a competent death receptor signaling pathway for the further evaluation of birinapant in the clinic.
  • ||||||||||  adafosbuvir (AL-335) / J&J, Medivir
    Journal:  Identification and analysis of sugar transporters capable of co-transporting glucose and xylose simultaneously. (Pubmed Central) -  Nov 6, 2021   
    Modelling studies of LST1_205437 revealed that Ala335 residue at sugar binding site can accommodates both glucose and xylose...In addition, we altered sugar preference of LST1_205437 by single amino acid mutation at Asn365. Our findings provide a new mechanistic insight on glucose and xylose transport mechanism of sugar transporters and the identified sugar transporters can be employed to develop engineered yeast strains for producing cellulosic biofuels and chemicals.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Biomarker, Journal:  Effectiveness of direct-acting antiviral drugs against hepatitis C virus: predictive factors of response to the treatment. (Pubmed Central) -  Oct 30, 2021   
    Presence of diabetes and complications related to liver disease (splenomegaly, portal hypertension, portal hypertensive gastropathy), body mass index ≥30, greater liver fibrosis, receiving simeprevir and higher baseline levels of glucose, aspartate-aminotransferase, alanine-aminotransferase and alkaline-phosphatase, have been identified as predictive factors of non-response (p < 0.05)...The effectiveness and safety of direct-acting antivirals against hepatitis C virus have been maintained in routine clinical practice. Further research on predictive factors of response is required in order to develop more reliable and reproducible predictive models.
  • ||||||||||  Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
    Retrospective data, Journal:  Inhaled loxapine for acute agitation in a psychiatric emergency service. (Pubmed Central) -  Oct 27, 2021   
    Further research on predictive factors of response is required in order to develop more reliable and reproducible predictive models. The rapid absorption of inhaled loxapine is associated with a 6-fold faster and more robust symptom control.
  • ||||||||||  [VIRTUAL] TRENDS IN HEPATOCELLULAR CARCINOMA AND ANTIVIRAL HEPATITIS TREATMENT IN OLDER AMERICANS () -  Oct 21, 2021 - Abstract #AASLD2021AASLD_913;    
    Despite a marked increase in the effectiveness and frequency of HCV treatment in 2014 and 2015, HCV-attributable HCC continued to rise through 2015. Future studies should examine the incidence of HCV-attributable HCC among older Americans in subsequent years to assess the effect of the introduction of DAA therapies for HCV in this population .
  • ||||||||||  fostroxacitabine bralpamide (MIV-818) / Medivir
    Enrollment closed, Trial completion date, Trial primary completion date:  A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations (clinicaltrials.gov) -  Oct 14, 2021   
    P1/2,  N=102, Active, not recruiting, 
    In HCV GT1- and GT2-infected Japanese patients, treatment with JNJ-4178 was well tolerated and resulted in 100% of patients achieving SVR12. Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> May 2023 | Trial primary completion date: Dec 2021 --> May 2023
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Increasing MHC-I expression to potentiate immune checkpoint blockade therapy () -  Oct 1, 2021 - Abstract #SITC2021SITC_1260;    
    We experimentally validated that the SMAC mimetic birinapant upregulates MHC-I, sensitizes cancer cells to T-cell-dependent killing, and adds to ICB efficacy...Our findings provide preclinical rationale for treating some tumors expressing low MHC-I with SMAC mimetics to enhance sensitivity to immunotherapy. The approach used in this study can be generalized to identify other drugs that enhance immunotherapy efficacy.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Increasing MHC-I expression to potentiate immune checkpoint blockade therapy (West Salons) -  Oct 1, 2021 - Abstract #SITC2021SITC_143;    
    We experimentally validated that the SMAC mimetic birinapant upregulates MHC-I, sensitizes cancer cells to T-cell-dependent killing, and adds to ICB efficacy...Our findings provide preclinical rationale for treating some tumors expressing low MHC-I with SMAC mimetics to enhance sensitivity to immunotherapy. The approach used in this study can be generalized to identify other drugs that enhance immunotherapy efficacy.
  • ||||||||||  birinapant (TL 32711) / Medivir
    Clinical, Journal:  Development of a protein signature to enable clinical positioning of IAP inhibitors in colorectal cancer. (Pubmed Central) -  Sep 30, 2021   
    We quantified the absolute expression of 19 key apoptotic proteins at baseline in a panel of 12 CRC cell lines representative of the genetic diversity seen in this disease to identify which proteins promote resistance or sensitivity to a model IAP antagonist [birinapant (Bir)] alone and in combination with SoC chemotherapy (5FU plus oxaliplatin)...Moreover, the LDA model was able to predict response accurately when cells were co-cultured with TNFα to mimic a pro-inflammatory tumour microenvironment. Thus, our study provides the starting point for a proteomics-based companion diagnostic that predicts response to IAP antagonist/SoC chemotherapy combinations in CRC.
  • ||||||||||  birinapant (TL 32711) / Medivir
    Journal, IO biomarker:  Convergence of pathway analysis and pattern recognition predicts sensitization to latest generation TRAIL therapeutics by IAP antagonism. (Pubmed Central) -  Sep 25, 2021   
    Applied to expression data of a cohort of n = 365 metastatic melanoma patients in a proof of concept in silico trial, the predictor suggested that IZI1551/Birinapant responsiveness could be expected for up to 30% of patient tumours. Overall, response frequencies in melanoma models were very encouraging, and the capability to predict melanoma sensitivity to combinations of latest generation TRAIL-based therapeutics and IAP antagonists can address the need for patient selection strategies in clinical trials based on these novel drugs.
  • ||||||||||  ketamine / Generic mfg.
    Journal:  Agitation in schizophrenia: origins and evidence-based treatment. (Pubmed Central) -  Sep 17, 2021   
    Comorbidities can contribute to agitation and can make an accurate differential diagnosis challenging. The ongoing development of rapidly acting novel formulations of antiagitation medications, if successful, may facilitate clinical treatment by providing additional options.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Trial termination:  Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) -  Sep 13, 2021   
    P3,  N=9, Terminated, 
    The ongoing development of rapidly acting novel formulations of antiagitation medications, if successful, may facilitate clinical treatment by providing additional options. Active, not recruiting --> Terminated; Study stopped due to low accrual and availability of other treatment options
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Extranodal Liver, Pancreas and Spleen Diffuse Large B Cell Lymphoma After Successful Treatment for Chronic Hepatitis C Infection Using Direct Acting Antiviral Therapy (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_2604;    
    The relationship for HCV infection and development of lymphomas is well established,but pathophysiology is not well understood.One of the most accepted hypotheses is chronic viral antigen stimulation and genetic mutations to lymphocytes arising from HCV‐induced replication proteins.Physicians need to be aware that DAA therapy is clearly effective for intra- and extrahepatic manifestations of the virus, but these patients are still at risk for malignancy regardless HCV serologic status.Figure: PET-CT SCAN showing in the lower half of the right liver lobe three large foci of increased tracer uptake, the larger lesion located on the anterolateral aspect of segment VIII measuring 4.3cm AP, also shows a soft tissue mass in pancreatic head with caudal extension that measures 3.7cm AP. There is no main pancreatic duct dilation (b), and a small lesion on superior-posterior aspect subcapsular area of the spleen (c).
  • ||||||||||  Pegasys (pegylated interferon α -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
    Trial completion date, Trial primary completion date:  SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) -  Aug 30, 2021   
    P2,  N=160, Recruiting, 
    We have novel clinical stage compounds to methodologically target different facets of the apoptotic pathway and optimize novel combinations with the goal to improve the cure rates in AML patients. Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Oct 2022
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal:  Anti-rod and ring antibodies in patients with chronic hepatitis C using direct-acting antivirals. (Pubmed Central) -  Aug 25, 2021   
    Only one of the 29 naïve patients (3.44%) developed anti-RR during the current treatment. Anti-RR was present in patients previously treated with interferon/ribavirin and can emerge after DAA treatment probably at a lower frequency than after interferon/ribavirin treatment.
  • ||||||||||  Preclinical, Journal:  Hepatitis C Virus Protease Inhibitors Show Differential Efficacy and Interactions with Remdesivir for Treatment of SARS-CoV-2 in Vitro. (Pubmed Central) -  Aug 25, 2021   
    Acyclic PIs asunaprevir and faldaprevir had ECs of 72 and 23 μM, respectively...Viral suppression was achieved with 3- to 8-fold EC50 boceprevir or 1-fold EC50 simeprevir or grazoprevir, but not boceprevir, in combination with 0.4- to 0.8-fold EC50 remdesivir; these concentrations did not lead to viral suppression in single treatments. This study could inform development and application of protease inhibitors for optimized antiviral treatments of COVID-19.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal:  Remission of long-term hepatic and renal disease induced by HCV after direct-acting antivirals therapy. (Pubmed Central) -  Aug 20, 2021   
    In these two cases, previously experienced to peg-interferon plus ribavirin, the sofosbuvir plus simeprevir therapy was effective, without significant side effects, and interrupted the evolution of at least 20 years of both hepatic and renal diseases. These cases join the seven previously described cases that were treated with this DAAs association.
  • ||||||||||  Journal:  How to treat mania. (Pubmed Central) -  Aug 20, 2021   
    Despite the evidence forefficacy of many currently available treatments for mania, the majority of RCTs provide little direction for the clinician as to what steps might be optimal in different presentations of mania as well as in the presence of specific patient characteristics. Manic episodes should be managed on a personalized basis considering the clinical course and patient criteria and with the expectation of maintaining that treatment in the long-term.