Avacta Group (AVCT ) will now move to the next dose cohort of its Phase I clinical study of AVA6000 Pro-doxorubicin following a positive safety review from patients in the first cohort.
AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Avacta, a clinical stage oncology drug company, is focused on developing diagnostics based on several of its technology platforms.
The company explained that Anthracyclines such as doxorubicin, a generic chemotherapy with a market size that is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but that their use is limited by cumulative toxicity.
As a result, AVA6000 has been designed to limit cell penetration of the drug, ‘and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues,’ it told investors.
The resulting reduced exposure of healthy tissues to active doxorubicin “has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects.”
Today, Avacta’s Safety Data Monitoring Committee (SDMC), which is composed of clinicians currently recruiting patients, announced that it has completed its review of the safety data from the group’s first cohort dosed with AVA6000 at 80mg/m2 in the ongoing Phase I trial.
Following this safety review, the SDMC has recommended that the first-in-human Phase I clinical trial continues as planned and escalates to the next dose of AVA6000 at 120mg/m2.
Dr Alastair Smith, CEO of Avacta Group, commented: “”We are very excited by the potential of AVA6000, and the pre|CISION platform more broadly, to deliver ground-breaking and affordable cancer treatments that have the potential to significantly improve patients’ lives.”
The US FDA approved Avacta’s Investigational New Drug (IND) application to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the US in November 2021.
The first patient from the Phase I multicenter trial evaluating AVA6000 in the UK was dosed back in August 2021. At the time, Avacta said the dose escalation phase was anticipated to be completed by 2Q22 followed by completion of the dose expansion phase by 2Q23.
Should the study show that Avacta’s technology is effective in reducing systemic toxicity of Doxorubicin in humans, the company believes that this would open up “an extensive and proprietary pipeline” of next-generation pre|CISIONTM pro-drug chemotherapies.
Avacta Group explained to investors that this would carry “significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 2027.”
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