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news.US biotechnology companies Chiron and Xoma have initiated a second clinical trial of CHIR-12.12, an antagonist antibody, in patients with multiple myeloma, a cancer of the blood.
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The novel, fully human, antagonist antibody targets the CD40 antigen which is associated with multiple myeloma.
The single-agent, open-label phase I study of CHIR-12.12 will recruit up to 40 patients and is designed to evaluate the safety, dose tolerability and pharmacokinetic profile of CHIR-12.12 in patients with multiple myeloma.
Translational medicine will be used to monitor biomarkers and allow correlation of these markers with response to CHIR-12.12 therapy, guiding the dosing regimen and the selection of responsive patient populations.
Multiple myeloma is a progressive hematologic (blood) cancer of the plasma cell (a type of B lymphocyte), an important part of the immune system that produces antibodies to help fight infection and disease. Clinical manifestations of multiple myeloma include hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin.
“Our collaboration with Chiron enables both companies to advance promising antibodies more quickly than either could alone. This benefits our employees and shareholders, as well as potentially offering a new treatment for multiple myeloma patients,” said John Castello, Xoma’s chairman, president and CEO.
Chiron and Xoma initiated a phase I clinical trial of CHIR-12.12 in patients with chronic lymphocytic leukemia in April 2005.