(Alliance News) - Avacta Group PLC on Wednesday said the first patient has been dosed in the fifth cohort of the first-in-human phase 1 trial of AVA6000, a novel form of doxorubicin designed to improve its safety and therapeutic index.
The life sciences company developing targeted oncology drugs and diagnostics said this follows the approval of an amended clinical trial protocol by the UK Medical & Healthcare Products Regulatory Agency to allow higher levels of dosing.
Avacta said its safety data monitoring committee, which is comprised of clinicians currently recruiting patients, has recommended dose escalation continues to a fifth dose cohort at 250 milligrams per square metre of body surface area, up from 200 in September.
This follows a "favourable" safety profile of AVA6000 generated in the study to date, Avacta said, while noting it needed MHRA approval as escalation to this level of dosing fell outside of the original clinical trial protocol.
It added this continued dose escalation is aimed at identifying a maximum tolerated dose necessary to inform the dosing levels for phase 1b of the study and future studies beyond.
"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 [safety data monitoring committee], and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial," said Chief Executive Officer Alastair Smith.
"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."
Shares in Avacta were up 4.3% to 120.98 pence each in London on Wednesday midday.
By Greg Rosenvinge, Alliance News reporter
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Avacta Group (AVCT)