Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) said that a panel of international experts in melanoma treatment met in Chicago to review and strengthen the registration study following the completion of the ongoing SCOPE trial.
Researchers plan to conduct a seamless adaptive phase II/III evaluation with an early interim analysis of the overall response rate (ORR) based on a central review of CT/MRI scans. The phase III component will focus on progression-free survival.
A nine-member group of experts reviewed and strengthened the study design.
Scancell CEO, Professor Lindy Durrant, said: "We are very grateful to the esteemed panel for their interest in our SCOPE results and their input into our further clinical study.
"The panel felt that the data was compelling enough to proceed to the phase II/III randomised registration study upon the completion of the SCOPE study."
Scancell continues to recruit patients for the SCOPE study, which is assessing the potential of Scancell immunotherapy treatments with SCIB1 and iSCIB1+.
So far, 32 out of 43 patients have been recruited into the SCIB1 cohort and 22 out of 43 into the iSCIB1+ cohort. Clinical results are expected in late 2024 and early 2025.
Scancell said a poster, presenting the first stage of the SCOPE study, was "very well received" at the American Society of Clinical Oncology conference.
"We were also overwhelmed by the interest in the poster, which is the most significant response I have seen in my career," said Durrant.