Avacta has announced the progression of dose escalation in the Phase I ALS-6000-101 clinical trial of AVA6000, a prodrug of the chemotherapy doxorubicin.
The latest move to progress to the next dose group comes after the Safety Data Monitoring Committee (SDMC) of the company provided a positive review.
The safety findings from the first arm administered with 80mg/m2 AVA6000 in the trial was reviewed by the SDMC, which comprises clinicians who are presently enrolling subjects.
On concluding the evaluation, the SDMC advised that the trial can progress as scheduled, with the next dose of AVA6000 increasing to 120mg/m2.
Avacta Group CEO Dr Alastair Smith said: “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.”
AVA6000 is a form of doxorubicin. It is designed to boost doxorubicin’s therapeutic index and safety using the pre|CISION platform of Avacta.
In November last year, the US Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application of Avacta for AVA6000.