Biothera has expanded the second arm of its clinical trial evaluating whether the combination of Imprime PGG® and Erbitux® can achieve positive outcomes for metastatic colorectal cancer (mCRC) patients without the use of chemotherapy, the company announced today.

Imprime PGG is a targeted immunotherapeutic drug candidate from Biothera that works synergistically with monoclonal antibodies through specific innate immune cell activation. Erbitux (cetuximab) is an anti-tumor monoclonal antibody from ImClone Systems that is approved for the treatment of colon cancer and head-and-neck cancer.

"We are excited about the initial results of the second arm of the trial," said Daniel Conners, Biothera chairman and founder. "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 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 (Erbitux and irinotecan) for second- and third-line mCRC patients. "The first arm is fully enrolled and we are seeing very positive results," said Conners. This arm, which the company had expected to be completed in 2008, is ongoing due to continued patient responses.

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.

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.

About Imprime PGG®

Imprime PGG is a novel immunotherapy that works synergistically with anti-tumor monoclonal antibodies to activate a large population of the body's immune cells (neutrophils) to kill cancer cells. Unlike other drugs that trigger a broad innate immune response, Imprime PGG selectively activates immune cells without inducing pro-inflammatory cytokines, which reduces potential side effects. As a platform therapeutic in oncology, Imprime PGG has the potential to improve patient response rates for existing monoclonal antibody therapies in approved indications, create new indications for these drugs and enhance the efficacy of development-stage monoclonal antibody drugs.

About Biothera, the Immune Health Company

Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer.

Biothera, the Immune Health Company

View drug information on Erbitux.