Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, announces that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the next dose cohort following a positive review of the safety data from the dosing of the first cohort.
Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the first cohort dosed with AVA6000 at 80mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 120mg/m2.
AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. 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 their use is limited by cumulative toxicity. 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 ? (FAP) which is in high concentration in many solid tumours compared with healthy tissues. 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, including cardiotoxicity and myelosuppression.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
“We are delighted with the SDMC’s recommendation to move on to the next dose of AVA6000 in our dose escalation study following its positive review of the safety data from patients in the first cohort.
“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.”