Individual receives AVA6000 treatment as part of additional dose escalating study
Avacta – a company developing targeted oncology drugs and diagnostics – has announced that the first individual has been dosed with its AVA6000 candidate.
The patient was among the fifth cohort of the first-in-human phase 1 trial involving the therapy. It comes after the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA) which allows higher levels of dosing.
Meanwhile, Avacta’s Safety Data Monitoring Committee (SDMC) – formed of clinicians currently recruiting patients – has recommended that the phase 1a dose escalation clinical trial continues to a fifth dose cohort at 250mg/m2.
This decision followed the favourable safety profile of AVA6000 generated in pervious clinical trials. The continued escalation to this level of dosing fell outside the established clinical trial protocol and, consequently, required an additional amendment and approval by the MHRA, which has duly been completed.
The latest dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to advise the levels of dosing for the forthcoming phase 1b research and, indeed, future studies.
Dr Alastair Smith, chief executive officer at Avacta Group plc, was in no doubt about the promise that the new trial could deliver: “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.”
He added: “The recent confirmation of release of active chemotherapy in the tumour tissue and the safety 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 tumour targeting potential of the pre|CISION platform.”