Avacta Group Share News (AVCT)

(Sharecast News) - Avacta Therapeutics said on Tuesday that it had agreed two key clinical protocol updates to its faridoxorubicin, or AVA6000, programme, removing the historic cardiac dosing limit and identifying a clear pathway to dose selection ahead of future efficacy studies.

The AIM-traded clinical-stage biopharmaceutical company said regulators and investigators approved changes to allow greater flexibility in dosing levels, following the accumulation of favourable safety data.

It said the previous maximum dosing limit, which was based on cumulative exposure to released doxorubicin, had been removed after patients in the phase one trial were observed receiving the highest cumulative doses over prolonged periods without evidence of severe cardiac toxicity.

Avacta said dosing in the phase one study escalated to nearly four times the conventional dose of doxorubicin, with maximum cumulative exposure to released doxorubicin increased to 550 milligrams per square metre, while no cases of severe cardiac toxicity were reported.

The company said that supported the core premise of its 'preCISION' tumour-activated delivery platform, which was designed to improve tolerability and enable longer treatment duration at higher doses, with the potential to extend progression-free survival in clinical trials.

It said the second update related to determining the optimal dose for future efficacy studies.

Avacta said final cohorts of patients in selected indications would be enrolled in the phase 1b study, enabling a comparison of two dose levels to identify the optimal biologic dose for subsequent trials.

"These two critical steps in the development of our faridoxorubicin programme and by extension the proprietary preCISION platform demonstrate growing recognition by regulators of the safety of this platform," said chief executive Christina Coughlin.

"Highly favorable cardiac safety data for faridoxorubicin enable patients to be treated longer, as opposed to stopping the drug for a theoretical risk of cardiac toxicity which is the usual practice with doxorubicin therapy.

"Despite dosing to nearly 4x the standard dose of doxorubicin as well as to a higher lifetime maximum exposure, we have not seen a single case of severe cardiac toxicity.

"Furthermore, identifying the path forward to the selection of the optimal biologic dose will enable a smooth transition to efficacy studies with faridoxorubicin program and allows the company to implement these approaches in the platform currently in phase 1b, facilitating the development across preCISION medicines," she added.

At 1313 GMT, shares in Avacta Group were up 13.23% at 56.9p.

Reporting by Josh White for Sharecast.com.