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news.Cerus Corporation has submitted an investigational new drug application to the FDA seeking approval to initiate a phase I safety trial for CRS-100, a listeria-based immunotherapeutic designed to treat patients with cancer that has metastasized to the liver.
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Preclinical studies demonstrate the potential of CRS-100 to stimulate a potent immune response against certain cancers in the liver. Cerus hopes to initiate a phase I clinical trial in collaboration with investigators at leading cancer centers in the US during the first half of 2006.
Colorectal cancer, which is the second most common cause of cancer death in the US, often metastasizes to the liver, contributing to its morbidity. Despite recent advances, metastasized colorectal cancer remains a significant unmet medical need.
“We believe that our listeria platform will lead to more potent and effective therapies that stimulate both innate and adaptive immune responses to target cancer cells,” said Claes Glassell, president and CEO of Cerus.