The Avacta Group Plc (LON: AVCT) share price rose 7.45% after announcing that it had dosed the first patient in the fifth cohort of the first-in-human phase I trial (ALS-6000-101) of AVA6000. The move comes after the Medical and Healthcare Products Regulatory Agency (MHRA) approved an amended clinical trial protocol for higher dosages.
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Investors cheered the announcement, which, if successful, could allow Avacta to launch AVA6000 at higher dosages than it had used in previous clinical trials. Avacta’s Safety Data Monitoring Committee (SDMC) recommended the phase 1A dose escalation study expands to a fifth dose cohort at 250mg/m2.
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The SDMC recommendation was based on the favourable safety profile of AVA6000 witnessed in the clinical trial. The dose escalation falls outside the original clinical trial protocol, so Avacta had to seek approval for its amended clinical trial protocol from the MHRA, which was granted.
Avacta’s dose escalation study is meant to identify the maximum tolerated dose (MTD) of AVA6000, which is crucial to determining the dosage levels for a Phase 1B clinical trial and further studies of the treatment.
AVA6000 is a tumour-activated form of doxorubicin developed using Avacta’s proprietary pre|CISION™ technology platform. The platform releases active drugs only within the tumour microenvironment, limiting systemic exposure and enhancing treatments’ safety and therapeutic potential for oncology indications.
Treatments developed using the pre|CISION™ technology platform include a substrate sensitive to cleavage by fibroblast activation protein (FAPα), preventing the drug from entering cells until it reaches the tumour microenvironment.
Dr Alastair Smith, Avacta Group’s CEO, commented: “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.”
Adding:
“The recent confirmation of the 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.”
*This is not investment advice.
Avacta share price.
The Avacta share price rose 7.45% to trade at 126.25p, from Tuesday’s closing price of 117.50p.
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