NOX66 is under development to enhance standard chemotherapy and radiotherapy. The target of idronoxil (the active constituent of NOX66), ENOX2, is an optimal candidate anti-cancer drug due to its tumour-cell specific expression. Inhibition of ENOX2 leads to a disruption of the TMEP, causing a cascade of intracellular actions leading to direct cytotoxicity and inhibition of DNA repair pathways. Three Phase 1 studies are underway to observe safety and efficacy signals - investigating multiple dose levels of NOX66 as monotherapy and in combination with carboplatin, palliative dose EBRT, and 177Lu-PSMA (a theranostic for treatment of prostate cancer). Data has previously been presented showing NOX66 400mg to be well tolerated as monotherapy and in combination with carboplatin. Here we present data for patients receiving 800mg NOX66. Methods
Nineteen patients with end stage metastatic cancer (breast, lung, prostate and ovarian) were enrolled between March and September 2017 across four centres in Georgia. Patients were allocated to one of three treatment cohorts: Cohort 1 (n = 8) receives 400mg NOX66 daily, Cohort 2 (n = 8) and 3 (n = 3) receive 800mg daily. Each patient receives NOX66 for up to seven months in the following regimen: - Part A: Monotherapy - 14 consecutive days of NOX66 treatment followed by 7 Days rest (Cohorts 1 and 2 only); - Part B: Carboplatin AUC4 - 3 x 28 Day cycles; NOX66 Days 1-7, Carboplatin Day 2; - Part C: Carboplatin AUC6 - 3 x 28 Day cycles; NOX66 Days 1-7, Carboplatin Day 2. Efficacy is measured by change in from baseline in radiological scans (using RECIST v 1.0 criteria) at End of Cycle 3 and Cycle 6. Adverse Events are monitored from enrolment until 30 days post Cycle 6. Results
Data presented is for Cohort 2, Part A and B (Cohort 1 presented at ESMO2017). Of the 8 patients treated with 800mg NOX66, 7 completed monotherapy (one withdrawal prior to dosing). No AEs related to NOX66 were reported. Following three cycles of combination with carboplatin AUC4, 1 patient reported partial response, 4 stable disease and 1 disease progression. No AEs related to NOX66 have been reported. Conclusions
NOX66 at 800mg is well tolerated as monotherapy and in combination with low dose carboplatin. Efficacy signals support further investigation of NOX66 in combination with standard chemotherapy.
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