Cancer drug AVA6000 continues to show a very favourable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation Phase I clinical trial.
Additionally, analysis of tumour biopsies obtained from six patients indicates that doxorubicin is being released within the tumour tissue, confirming the tumour targeting potential of the pre|CISION technology.
There has been a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy. Importantly, even at the highest dosing levels in cohort 4, equivalent to more than double the normal dose of doxorubicin, the typical drug-related cardiotoxicity of doxorubicin was not observed.
Tumour biopsies obtained from patients in different cohorts shows that AVA6000 targets the release of doxorubicin to the tumour tissue at therapeutic levels which are much higher than the levels being detected in the bloodstream at the same timepoint.
Chemotherapy without side effects
Nineteen patients with a range of advanced and/or metastatic solid tumours enrolled across four cohorts, have been administered AVA6000 to date. Based on the favourable safety profile of AVA6000, the Safety Data Monitoring Committee (SDMC) recommended continuation to higher dose cohorts with the aim of identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase Ib and future studies.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We’re delighted with the very positive data emerging from the dose escalation study of our lead pre|CISION tumour targeted therapy AVA6000. The very significant reduction in the usual toxicities, plus the observed release of doxorubicin at significant levels in the tumour tissue, show that the pre|CISION platform has the potential to significantly improve the safety and tolerability of chemotherapies, and other drugs, by targeting their release to the tumour.
“This is extremely encouraging as we work towards realising our vision of “chemotherapy without side effects” to make a meaningful difference to cancer patients’ lives.”