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  • ||||||||||  Lumakras (sotorasib) / Amgen, Tarlox (tarloxotinib bromide) / Pathos
    Trial termination:  Tarlox and Sotorasib in Patients With KRAS G12C Mutations (clinicaltrials.gov) -  Jan 17, 2024   
    P1/2,  N=5, Terminated, 
    Active, not recruiting --> Terminated; Study drug was discontinued by manufacturer for business reasons.
  • ||||||||||  Tarlox (tarloxotinib bromide) / Molecular Templates, Proacta, Rain Oncology, Signpath Pharma
    Application and mechanism of tarloxotinib in HER2-positive breast cancer () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_1685;    
    Conclusions Tarloxotinib released Tarloxotinib-E under hypoxic microenvironment of breast tumors, and inhibited the phosphorylation of HER2 dimers and downstream pathways to induce apoptosis in HER2-positive cells through a ROS-dependent manner. This lays a foundation for the further development of Tarloxotinib in HER2-positive breast cancer.
  • ||||||||||  Lumakras (sotorasib) / Amgen, Tarlox (tarloxotinib bromide) / Pathos
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Tarlox and Sotorasib in Patients With KRAS G12C Mutations (clinicaltrials.gov) -  Jul 12, 2023   
    P1/2,  N=5, Active, not recruiting, 
    The study opened in April 2022 and is currently enrolling. Recruiting --> Active, not recruiting | N=30 --> 5 | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2023 --> Jul 2023
  • ||||||||||  PR104 / Proacta
    THE EPIDEMIOLOGY OF ESOPHAGEAL CANCER IN ACHALASIA; A LARGE POPULATION BASED NATIONAL STUDY. (Poster Hall - San Diego Convention Center) -  Apr 25, 2022 - Abstract #DDW2022DDW_1785;    
    This increased prevalence of esophageal cancer in patients with achalasia was present when patients were stratified by age (Adults PR 26.6 (21.0-33.6), p<0.001; Elderly PR 7.21 (6.17-8.41), p<0.001); race (Caucasian PR 13.3 (11.6-15.3), p<0.001; African American PR 104.6 (73.1-150), p<0.001), and gender (Male PR 3.68 (3.15-4.30), p<0.001; Female PR 21.7 (17.4-27.0), p<0.001)...Surveillance endoscopies for patients with achalasia remains controversial. Our data supports continued surveillance given the significant elevated risk of development of esophageal cancer in those patients.
  • ||||||||||  Mustargen (mechlorethamine) / Recordati, CP-506 / Convert Pharma
    PK/PD data, Journal:  Tissue Pharmacokinetic Properties and Bystander Potential of Hypoxia-Activated Prodrug CP-506 by Agent-Based Modelling. (Pubmed Central) -  Feb 26, 2022   
    In the present study, we investigate the pharmacological properties of the nitrogen mustard prodrug CP-506 in tumour tissues using in silico spatially-resolved pharmacokinetic/pharmacodynamic (SR-PK/PD) modelling...Our simulations predict a striking bystander efficiency at tissue-like densities with the bis-chloro-mustard amine metabolite (CP-506M-Cl) identified as a major diffusible metabolite. Overall, this study shows that CP-506 has favourable pharmacological properties in tumour tissue and supports its ongoing development for use in the treatment of patients with advanced solid malignancies.
  • ||||||||||  Tarlox (tarloxotinib bromide) / Molecular Templates, Proacta, Rain Therap, Signpath Pharma
    Journal:  Tarloxotinib is a hypoxia-activated pan-HER kinase inhibitor active against a broad range of HER-family oncogenes. (Pubmed Central) -  Feb 11, 2022   
    Overall, this study shows that CP-506 has favourable pharmacological properties in tumour tissue and supports its ongoing development for use in the treatment of patients with advanced solid malignancies. Experimental data with tarloxotinib validate the novel mechanism of action of a hypoxia-activated prodrug in cancer models by concentrating active drug in the tumor vs. normal tissue and this activity can translate into clinical activity in patients.
  • ||||||||||  Tarlox (tarloxotinib bromide) / Molecular Templates, Proacta, Rain Therap, Signpath Pharma
    Preclinical, Journal, EGFR exon 20:  Activity of tarloxotinib-E in cells with EGFR exon-20 insertion mutations and mechanisms of acquired resistance. (Pubmed Central) -  Dec 23, 2021   
    These findings indicate that tarloxotinib-E could be effective for NSCLC with EGFR exon 20 mutations. Our results also show that T790M or C797S mutations can confer acquired resistance to tarloxotinib-E; and suggest that resistance mechanisms are influenced by the baseline EGFR exon 20 mutations.
  • ||||||||||  CP-506 / Convert Pharma, Tarlox (tarloxotinib bromide) / Molecular Templates, Proacta, Rain Therap, Signpath Pharma, evofosfamide (TH 302) / Molecular Templates, ImmunoGenesis
    Review, Journal:  Tumour Hypoxia-Mediated Immunosuppression: Mechanisms and Therapeutic Approaches to Improve Cancer Immunotherapy. (Pubmed Central) -  Nov 10, 2021   
    Accumulating evidence suggests that tumour hypoxia, a pervasive feature of many solid cancers, is a critical phenomenon involved in suppressing the anti-tumour immune response generated by checkpoint inhibitors. In this review, we discuss the mechanisms associated with hypoxia-mediate immunosuppression and focus on modulating tumour hypoxia as an approach to improve immunotherapy responsiveness.
  • ||||||||||  Review:  Targeting Hypoxia: Hypoxia-Activated Prodrugs in Cancer Therapy. (Pubmed Central) -  Aug 17, 2021   
    Both single-agent and combined use with other drugs have shown promising antitumor effects. In this review, we discuss the mechanism of action and the current preclinical and clinical progress of several of the most widely used HAPs, summarize their existing problems and shortcomings, and discuss future research prospects.
  • ||||||||||  Review, Journal:  NRG1 fusions: Biology to therapy. (Pubmed Central) -  Aug 5, 2021   
    Supporting data are limited to case reports and small series for now, but prospective trials are underway. While our understanding of these fusions is still evolving, it is clear that NRG1 will be a clinically relevant finding in the years to come.
  • ||||||||||  Tarlox (tarloxotinib bromide) / Molecular Templates, Proacta, Yakult Honsha, Rain Therap
    Journal:  Bispecific repurposed medicines targeting the viral and immunological arms of COVID-19. (Pubmed Central) -  Jul 9, 2021   
    The caspase-1 inhibitor SDZ 224015, was found to be a potent irreversible inhibitor of M (IC 30 nM) while Tarloxotinib, a clinical stage epidermal growth factor receptor inhibitor, is a sub micromolar inhibitor of PL (IC 300 nM, K 200 nM) and is the first reported PL inhibitor with drug-like properties. SDZ 224015 and Tarloxotinib have both undergone safety evaluation in humans and hence are candidates for COVID-19 clinical evaluation.
  • ||||||||||  PR104 / Proacta Inc.
    Journal:  E. coli nitroreductase NfsA is a reporter gene for non-invasive PET imaging in cancer gene therapy applications. (Pubmed Central) -  Jun 2, 2021   
    Following PET imaging with F-HX4, a significantly higher tumor-to-blood ratio was observed in two xenograft models for NfsA_Ec expressing tumors compared to the parental tumors thereof, providing verification of this reporter gene imaging approach. This study establishes that the bacterial nitroreductase NfsA_Ec can be utilized as an imaging capable reporter gene, with the ability to metabolize and trap 2-nitroimidazole PET imaging agents for non-invasive imaging of gene expression.