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Imprime PGG is a targeted immunotherapeutic drug candidate from Biothera that works synergistically with monoclonal antibodies through specific innate immune cell activation. Erbitux is an anti-tumor monoclonal antibody from ImClone Systems that is approved for the treatment of colon cancer and head-and-neck cancer.
The Biothera metastatic colorectal cancer (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.
The additional patients will be dosed at the study protocol's existing dose levels. With the expansion of the second arm, the trial will now include 32 patients. The first arm of the Biothera's mCRC trial is studying the combination of Imprime PGG with the standard of care for second- and third-line mCRC patients.
Daniel Conners, chairman and founder of Biothera, said: "We are excited about the initial results of the second arm of the trial. We believe Imprime PGG and Erbitux alone can improve patient outcomes without the harmful side effects of chemotherapy. In fact, with continued clinical success, this combination therapy could change the way many cancers are treated.
"The first arm is fully enrolled and we are seeing very positive results. This arm, which the company had expected to be completed in 2008, is ongoing due to continued patient responses."
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