Biothera Initiates Second Arm Of Metastatic Colorectal Cancer Trial

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology;  GastroIntestinal / Gastroenterology;  Clinical Trials / Drug Trials
Article Date: 16 Oct 2008 - 6:00 PDT

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Biothera 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 without 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.

About Imprime PGG®

Imprime PGG is a novel immunotherapy that can enhance the immune response against a number of disease indications. Imprime PGG works in concert 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. www.biothera.com

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