Biothera Completes Enrollment Of First Arm Of Metastatic Colorectal Cancer Trial

Main Category: Colorectal Cancer
Also Included In: GastroIntestinal / Gastroenterology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 08 Oct 2008 - 7:00 PST

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Biothera announced today that it completed enrollment in the first arm of its metastatic colorectal cancer (mCRC) trial in July. The dual-arm trial is evaluating the combination therapy of Imprime PGG®, the company's lead drug candidate, and Erbitux® (cetuximab), 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 mCRC 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 initial results are highly promising," said Daniel Conners, Biothera chairman and founder. "Imprime PGG is well tolerated and we are seeing a very positive response in early treatment cycles." 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.

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. This unique benefit reduces potential side effects of Imprime PGG. 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. http://www.biothera.com