Milatuzumab-doxorubicin conjugate testing

Immunomedics, Inc. announced that the U.S. FDA has allowed its investigational new drug application to initiate Phase I/II clinical trials of doxorubicin conjugate of milatuzumab. The company noted that this is the first antibody-drug conjugate to enter human testing for the treatment of patients with multiple myeloma.

The company said that the primary objective of the open-label, multi-center study is to evaluate the safety and tolerability of the antibody-drug conjugate in patients with recurrent or refractory multiple myeloma. Preliminary information on efficacy, pharmacokinetics, and immunogenicity will also be obtained.

Milatuzumab is a monoclonal antibody that has been designed to recognise and bind to a specific structure (called an antigen) called CD74. This is a receptor protein that is often found on the surface of multiple myeloma cells and is involved in the growth and survival of the cells. By attaching itself to the CD74 on cancer cells, milatuzumab is expected to stop their development and cause the cells to die.

Milatuzumab is being studied clinically for the treatment of multiple myeloma, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. Milatuzumab is the first anti-CD74 antagonistic antibody to enter clinical trials.