Colorectal cancer is the second leading cause of cancer-related death in both men and women in the U.S. It is estimated that over 148,000 new cases of colorectal cancer are reported each year, accounting for more than 56,000 deaths annually. Over 60 % of colorectal cancers are metastatic by the time they are diagnosed. Current treatment options include surgery, radiation and chemotherapy, all of which can result in serious adverse side effects. Over 90% of patients diagnosed and treated for metastatic colorectal cancer die within five years.
PRODUCT CANDIDATES Since 1998, Therion and Aventis Pasteur Limited have been engaged in a collaboration to develop pox virus-based vaccines for the treatment of colorectal cancer and melanoma. The collaboration's lead product, ALVAC-CEA/B7.1, is a vaccine for the treatment of colorectal cancer, currently in Phase II clinical investigation.
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ALVAC-CEA/B7.1 � This product candidate uses a recombinant pox vector to target carcinoembryonic antigen (CEA) a protein found on a majority of colorectal and cancer cells. In addition to CEA, the vaccine also incorporates a single co-stimulatory component to enhance antigen presentation and activation of cytotoxic T-cells critical for tumor destruction. ALVAC-CEA/B7.1 was found to be safe and well tolerated in Phase I clinical trials in 57 patients, most of whom had late-stage colorectal cancer. Furthermore, these early clinical studies demonstrated the vaccine's ability to elicit critical cell-mediated immune responses to CEA and to stabilize disease in a subset of patients. ALVAC-CEA/B7.1 is expected to enter Phase III trials in 2004.
Clinical Trial Sites
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