Allarity Therapeutics Inc ALLR said that for Ixempra and stenoparib monotherapy trials, Allarity is taking steps to accelerate patient recruitment to support the goals for interim data readouts by the end of 2023.
Due to slower than anticipated patient enrollment in both studies, partly due to the COVID pandemic’s impact on trial site staffing, Allarity has expanded its collaboration with multiple contract research organizations (CROs) to increase the number of active trial sites substantially.
The company has also changed the clinical trial protocols to increase the availability of eligible participants for both monotherapy studies.
Allarity is sponsoring an ongoing DRP-guided Phase 2 trial evaluating IXEMPRA as a monotherapy in metastatic breast cancer in Europe.
In addition to expanding its CRO partnerships, Allarity has implemented a trial protocol amendment that will lower the Ixempra-DRP companion diagnostic cut-off score for enrollment from 67% to 33%.
As a result, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.
The company is also evaluating stenoparib as monotherapy in ovarian cancer in an ongoing DRP-guided Phase 2 clinical trial.
Based on early data (unpublished) from this study and in consultation with trial investigators, Allarity has implemented a trial protocol amendment to change patient dosing from once daily dose to a BID regimen (twice daily).
Earlier this month, Allarity commenced a Phase 1b study evaluating the combination of stenoparib and dovitinib for advanced solid tumors, including ovarian cancer.
Price Action: ALLR shares are down 8.17% at $2.36 during the premarket session on the last check Tuesday.
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