Avacta Group has dosed its first patient in the fifth cohort of the first-in-human Phase I trial (ALS-6000-101) of AVA6000 in solid tumours.
This follows the approval of an amended clinical trial protocol by the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) to allow for higher levels of dosing.
Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has recommended that the Phase Ia dose escalation clinical trial continues to a fifth dose cohort at 250mg/m, following the favourable safety profile of AVA6000 generated in the study to date.
Escalation to this level of dosing falls outside of the original clinical trial protocol, and therefore the protocol required amendment and approval by the MHRA, which has now been completed.
This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase 1b and future studies.
Dr Alastair Smith, Chief Executive Officer of Avacta Group plc, commented: “We are very much encouraged by the positive safety and tolerability data emerging from the dose escalation phase 1a study of AVA6000. Following the recommendation from the SDMC, and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial.”
