Avacta Announces Successful Completion of Fourth Dose Escalation in Phase 1 Clinical Study
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Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics announces that AVA6000 continues to show a very favourable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial. Additionally, analysis of tumour biopsies obtained from six patients across several cohorts indicates that doxorubicin is being released within the tumour tissue, confirming the tumour targeting potential of the pre|CISION™ technology.
AVA6000 continues to be well tolerated by patients in cohort 4, with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration. Typical toxicities include alopecia, myelosuppression, nausea, vomiting, mucositis, and cardiotoxicity. 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.
A number of tumour biopsies obtained from patients in different cohorts have also been analysed in order to confirm the release of the active chemotherapy, doxorubicin, in the tumour tissue. This analysis 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.
Nineteen patients with a range of advanced and/or metastatic solid tumours enrolled across four cohorts, have been administered AVA6000 to date. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has 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 1b and future studies. The Company expects that it will complete these additional cohorts during the first half of 2023.
Dr Alastair Smith, Chief Executive Officer of Avacta Group plc 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.
“We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which is an unexpected and very positive development. The data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISION™ platform, which add significant value to the technology and confirm the potential of the pre|CISION™ platform.”