|Source||Humanized (from mouse)|
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The drug is the first anti-CD74 antibody that has entered into human testing and is currently being studied for the treatment of multiple myeloma. Milatuzumab has received orphan drug designation from the Food and Drug Administration in the United States for the treatment of multiple myeloma and chronic lymphocytic leukemia.
CD74 is present on a variety of hematological tumors and even on some solid cancers. It is that it is present in limited amounts in normal tissues but widely found in leukemias, lymphomas and the vast majority of multiple myeloma cases. CD74 is involved in a cell-to-cell communication pathway that is critical for survival. When CD74 is blocked by milatuzumab, it can lead to cell death.
In preclinical studies with human lymphomas and myelomas, both naked Milatuzumab and the Milatuzumab conjugated with doxorubicin, an antibody-drug conjugate or ADC, have demonstrated anti-lymphoma activity in-vivo.
CD74 is an attractive target for a drug conjugate because of its rapid internalizing property.
Milatuzumab has been linked to doxorubicin to form an antibody-drug conjugate or ADC (know as hLL1-Dox) for treatment of relapsed multiple myeloma. A phase I/II clinical trial has started. This open-label, multi-center Phase I/II study aims to evaluate the safety and tolerability of milatuzumab-doxorubicin conjugate in patients with recurrent or refractory multiple myeloma, and to obtain preliminary information on efficacy, pharmacokinetics, and immunogenicity. The ADC will be administered intravenously on days 1, 4, 8, & 11 every 21 days for up to 8 treatment cycles. Four different dose levels of the doxorubicin conjugate of milatuzumab will be studied in groups of 3-6 patients. Once an optimal dose has been found, up to an additional 30 patients will be studied at that dose level.
Milatuzumab was developed by Immunomedics, Inc, (Morris Plains NJ USA).
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