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The FDA says there have been problems in monitoring patients and record-keeping at the Garden State Cancer Center in New Jersey.
"The GSCC's clinical trials have been temporarily suspended by FDA because
of deficiencies in monitoring and record-keeping, and not any product-related
adverse events or certainly any deaths," stated Dr. Raymond Menard, vice
president of the Garden State Cancer Center in Belleville, N.J. "We
expect to have these documentation problems corrected and the trials resumed
in the near future."
Dr. David M. Goldenberg, chairman and CEO of Immunomedics, explained: "Two
early-phase, pilot studies sponsored by Immunomedics were included in the hold
at the Garden State Cancer Center, but do not affect the Company's product
development program, because these same trials are ongoing at other centers.
One involves a radiolabeled antibody to carcinoembryonic antigen (CEA), but
which was never initiated because trials are already being done elsewhere; the
second involves a dose-escalation of the naked antibody to CEA in colorectal
and breast cancer patients. Three patients have been successfully enrolled in
the latter trial at GSCC, with further accrual scheduled to occur at two other
participating medical centers."
"Most importantly, no studies of our most advanced product, non-isotopic
epratuzumab for the treatment of non-Hodgkin's lymphoma, were being conducted
at GSCC," he added.
Immunomedics is a biopharmaceutical company focused on the development,
manufacture and commercialization of diagnostic imaging and therapeutic
products for the detection and treatment of cancer and infectious diseases.
Integral to these products are highly specific monoclonal antibodies and
antibody fragments designed to deliver radioisotopes and chemotherapeutic
agents to tumors and sites of infection.
The company's first product,
CEA-Scan(R) for the detection of colorectal cancer, is being marketed in the
United States and Europe (approved in Canada). The company's second
diagnostic imaging product, LeukoScan(R), is being marketed in Europe for the
diagnosis of osteomyelitis (bone infection). Immunomedics also has several
other diagnostic imaging products and three therapeutic products in clinical
trials.
The most advanced therapeutic products are LymphoCide(TM)
(epratuzumab), which is beginning Phase III clinical trials for the treatment
of non-Hodgkin's lymphoma, and CEA-Cide(TM), which is in Phase I/II clinical
trials for the treatment of certain solid tumors.
Source: Immunomedics Inc.
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