Biothera Completes Enrollment of First Arm of Colorectal Cancer Trial
Biothera, a biotechnology company, has completed enrollment in the first arm of its metastatic colorectal cancer trial. The dual-arm trial is evaluating the combination therapy of Imprime PGG, the company’s lead drug candidate, and Erbitux, a monoclonal antibody from ImClone Systems, with or without chemotherapy.
The first arm of the clinical trial will assess the safety and efficacy of various dose levels of Imprime PGG in combination with Erbitux and irinotecan, a chemotherapy drug, which is the standard of care for second- and third-line metastatic colorectal cancer patients.
The second arm will evaluate Imprime PGG and Erbitux alone. This Phase Ib/IIa mCRC trial is an open-label, multicenter study in Asia. The first arm of the trial should be completed by the end of 2008.
Imprime PGG has demonstrated a strong safety profile in four clinical trials, including two Phase I trials with Imprime PGG alone in healthy subjects, a Phase Ib trial with Imprime PGG in combination with a hematopoietic growth factor, and the ongoing Phase Ib/IIa trial in combination with a monoclonal antibody in colorectal cancer patients.
Daniel Conners, chairman and founder of Biothera, said: “The initial results are highly promising. Imprime PGG is well tolerated and we are seeing a very positive response in early treatment cycles.”