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Studies Point to Benefits of Personalized Chemotherapy Dose Management in Colorectal Cancer
Date:5/2/2008

lized 5-FU dose management was also reinforced in two studies reported earlier this year at the American Society of Clinical Oncology (ASCO) Gastrointestinal Symposium. Results from these Phase II studies of metastatic colorectal cancer patients treated with 5-FU (in combination regimens commonly used in the U.S., FOLFOX and FOLFIRI) demonstrated improved response rates and reduced toxicities with blood level dose management.(1)

New, Multicenter Study Seeks to Use Faster, Less Expensive Blood Test

To date, analysis of 5-FU patient blood concentrations could only be performed by complex, labor-intensive methods, such as liquid chromatography-mass spectroscopy (LC-MS). Saladax Biomedical, Inc., a Bethlehem, Pa.-based biotech company, is sponsoring a soon-to-enroll study to support the case for blood-based 5-FU dose management with the FOLFOX regimen. The study will employ a new immunoassay based on a patented technology from Saladax. The assay, called Personalized Chemotherapy Management (PCM), provides LC-MS-like performance but is easier to use and less expensive.

The multicenter, randomized Phase III study will enroll more than 200 patients with metastatic colorectal cancer to determine the efficacy of 5-FU dose management utilizing the PCM test. Edward Chu, M.D., chief of Medical Oncology and deputy director of the Yale Cancer Center in New Haven, Conn., will be the lead investigator of the study, which will involve several other cancer centers in the U.S., as well as the Paul Papin Cancer Center in France.

"Therapeutic dose management is common for many important drugs in other areas of medicine. Based upon recent evidence that we can lower toxicity and improve efficacy with personalized 5-FU dose management, it makes sense to use this same approach in cancer treatment," said Dr. Chu. "We hope that this study will provide oncologists with important evidence and guidance on the role of drug monitoring in their routine practice," he adde
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SOURCE Saladax Biomedical
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