May 19 2011
Biothera began dosing patients today in a Phase III trial evaluating Imprime PGG® in combination with cetuximab (Erbitux®) as a potential new treatment for recurrent or progressive KRAS wild-type colorectal cancer.
The trial design is built on data obtained in the company's previous clinical studies in colorectal cancer. Biothera has reviewed these results, as well as the protocol for the Phase III study, with the U.S. Food and Drug Administration. The endpoints for the study are designed to include an opportunity for accelerated approval based on interim data.
"Late stage colorectal cancer patients who can neither tolerate nor benefit from chemotherapy represent a large unmet clinical need," said Dan Conners, president of Biothera's Pharmaceutical Group. "Based on previous trials, we are confident that the combination of Imprime PGG and cetuximab will prove effective in treating this disease and further extending the survival and quality of life in these patients."
Study Design
The open-label, randomized study will enroll up to 795 patients and will be conducted in over 50 locations worldwide, including the U.S., Europe and South America.
Patients will be randomized to one of two study arms in a 2:1 ratio. A total of 530 subjects in Arm 1 will receive Imprime PGG and cetuximab and a total of 265 subjects in Arm 2 will receive cetuximab alone. The patients must have received at least two prior chemotherapeutic regiments and cannot have been previously treated with cetuximab or panitumumab.
The primary endpoint for the study is overall survival. Secondary endpoints are progression-free survival, tumor response and quality of life.
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