Biothera initiates second phase of metastatic colorectal cancer trial

Biothera has announced today it began dosing patients in the second arm of its metastatic colorectal cancer (mCRC) trial in August.

This arm of the trial is evaluating the combination therapy of its lead drug candidate, Imprime PGG, with Erbitux, an anti-cancer monoclonal antibody from ImClone Systems. Unlike the first trial arm, the second treatment arm does not include chemotherapy.

In the first arm of the trial, which was fully enrolled this past July, Imprime PGG was combined with Erbitux (cetuximab) and irinotecan, a chemotherapy drug, which is the standard of care for second- and third-line mCRC patients.

"We are very excited about the initial results from the first arm of our mCRC trial," said Daniel Conners, Biothera chairman and founder. "In the second arm, we expect that patients receiving Imprime PGG and Erbitux alone can achieve positive outcomes with the horrendous side effects of irinotecan chemotherapy."

Imprime PGG utilizes a novel mechanism of action that activates specific immune cells to kill antibody targeted cancer cells. The mobilization of a population of innate immune cells not normally involved in anti-tumor activity has the potential to dramatically enhance existing cancer monoclonal antibody therapy. Irinotecan and other chemotherapies are effective at killing cancer cells, but they also can cause serious toxicity and potentially life-threatening side effects by suppressing immune system function.

"If we can match or exceed the treatment efficacy of the Erbitux and irinotecan therapy without the corresponding toxicities associated with irinotecan, we may be able to provide an exciting treatment option for cancer patients in terms of enhanced survival and quality of life," said Conners.

The Biothera mCRC clinical trial is an open-label, multicenter trial in Asia. In both arms, the study is evaluating the safety and efficacy of Imprime PGG at various dose levels.