Immunomedics Announces FDA Allowance of Investigational New Drug Application for Milatuzumab-Doxorubicin Conjugate

Immunomedics, Inc. , a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the allowance of an investigational new drug (IND) application filed with the U.S. Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with multiple myeloma. This product candidate is the Company's first antibody-drug conjugate to enter human studies.

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.

"Due to its rapidly internalizing nature when bound to the CD74 receptor, milatuzumab is an ideal antibody for the targeted delivery of chemotherapeutic agents, such as doxorubicin, to tumors expressing CD74, as indicated in several articles published by our scientists," commented Cynthia L. Sullivan, President and CEO. "We are pleased with the allowance and are eager to begin the clinical assessment of the antibody-drug conjugate, which has demonstrated very potent anti-tumor activities in preclinical studies," she added. Ms. Sullivan elaborated further: "Our chemists have developed some unique drug conjugation methods that have been applied to doxorubicin, as well as to SN-38, the active principle of irinotecan (CPT-11), a potent drug used in the treatment of metastatic colorectal cancer. Thus, we intend this to be the first in a series of clinical studies to evaluate the therapeutic opportunities for our antibody-drug conjugates."

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