Avacta has cleared another small hurdle in its race to provide an improved doxorubicin using its delivery platform. The safety data monitoring committee gave the thumbs-up to Avacta after reviewing data from the second dose cohort, clearing the company to step up to the next level.
Doxorubicin is a powerful chemotherapy medication, but its potency brings problems, with cardiotoxicity issues limiting the patient populations that are eligible for treatment with the drug. Avacta identified the limitations of the drug molecule as an opportunity for its pre|CISION technology, specifically by adding a substrate that is sensitive to cleavage by fibroblast activation protein. The substrate stops the drug from entering cells, keeping it inert until it encounters an enzyme found in the tumor microenvironment.
Cambridge, U.K.-based Avacta began assessing whether its idea translates into an improved risk-benefit profile in humans last summer, when it initiated enrollment of participants with certain locally advanced or metastatic solid tumors in a phase 1 trial. The 80-subject clinical trial is scheduled to wrap up next year.
In its latest update on the study, Avacta revealed the safety monitoring committee has cleared the trial to continue after reviewing data from the second, 120-mg/m2 cohort. Avacta will now escalate dosing to the third level.
“The recommendation from the safety data monitoring committee to initiate dosing in cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date. We look forward to providing additional updates as the dose escalation phase of the trial progresses,” Neil Bell, chief development officer of Avacta, said in a statement.
Avacta is running the first, dose-escalation stage of the phase 1 trial to determine the recommended dose for phase 2. Once the company has decided on a dose, it will initiate a phase 1b trial in up to three of the tumor types assessed in the first part of the study, using the initial clinical data to guide its choice.