SAN ANTONIO, June 2 /PRNewswire/ -- Immunomedics, Inc. (Nasdaq: IMMU)
today reported favorable clinical results in studies of three of its diagnostic imaging products -- CEA-Scan(R) for breast cancer, AFP-Scan(TM) for hepatocellular (liver) cancer, and LeukoScan(R) for acute, atypical appendicitis. The clinical findings were presented at the 44th Society of Nuclear Medicine Annual Meeting in San Antonio, Texas.
Dr. Hani Nabi of the State University of New York at Buffalo reported on the ability of CEA-Scan to improve on the low specificity of mammograms and thereby potentially reduce the number of unnecessary breast biopsies. In a study of 41 women with non-palpable, indeterminate mammograms, where actual presence of disease was confirmed in only 5, or 12%, of the cases, CEA-Scan demonstrated a sensitivity of 60% and specificity of 92%. "CEA-Scan was far superior to mammography in identifying breast cancer in the group of patients with indeterminate mammograms," Dr. Nabi reported. "Because of the product's high true-negative rate in this group, we believe it may play an important role in reducing the need for breast biopsies," he added.
CEA-Scan is currently approved in the U.S. and Europe for the detection of colorectal cancer. Immunomedics is working with the Food and Drug Administration to assess the product's potential role, in conjunction with mammography, for the detection of breast cancer.
In the second study, Dr. Stefan Dresel of the University of Munich, Germany, reported on results with 25 patients to assess the clinical utility of AFP-Scan, the Company's imaging agent for the detection of hepatocellular cancer, in comparison to computed tomography (CT). AFP-Scan achieved a higher sensitivity (95% vs. 63%) and specificity (67% vs. 17%) than CT, with an overall accuracy of 88% vs. 52%. "This product appears to be a promising new antibody imaging kit for the disclosure of sites of hepatocellular cancer," Dr. Dresel concluded, "and it should aid in the management of these patients by revealing sites of primary, recurrent, and metastatic disease with a single imaging modality."
AFP-Scan is currently completing Phase II clinical trials in liver and germ-cell cancers.
In the third study, Dr. Bruce Barron of the University of Texas Medical School in Houston, Texas, reported on the ability of LeukoScan to detect or rule out acute, non-classic appendicitis. The agent was studied in 94 evaluable patients who presented with a suspicion of the disease. In 21 surgical patients, LeukoScan was positive for 19 (91% sensitivity), and was negative in 62 out of 73 surgical and non-surgical patients who did not have appendicitis (85% specificity). "We concluded that LeukoScan is safe and clinically useful in the evaluation of these patients," said Dr. Barron. He added that the product provided significant clinical benefit by reducing the number of patients requiring other diagnostic tests by 39%, and by substantially increasing the number of patients who could be discharged instead of remaining under observation by almost threefold, thus potentially reducing unnecessary hospital costs.
LeukoScan was also evaluated in a subset of 27 children with non-classic acute appendicitis. Dr. Anthony M. Passalaqua and associates, from the Children's Hospital Medical Center of Akron, in Ohio, reported that within 4 hours of imaging, LeukoScan showed a sensitivity, accuracy and negative predictive value, using SPECT imaging, of 92%. The authors concluded that "LeukoScan is a rapid, simple and effective method to evaluate suspected non-classic acute appendicitis in children."
LeukoScan, Immunomedics' infectious disease imaging agent, is currently undergoing regulatory review by the U.S. Food and Drug Administration. The Company is seeking approval for use of the product in diagnosis of osteomyelitis in long bones and diabetic foot ulcers, as well as for acute, atypical appendicitis. The Company has received approval in Europe for the osteomyelitis indication and has filed for approval of the appendicitis indication.
Immunomedics is a biopharmaceutical company focused in 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 for the detection of colorectal cancer, has been approved in both the U.S. and Europe and is being marketed by Mallinckrodt Inc. and its European affiliate, Mallinckrodt Medical B.V. The Company's second product, LeukoScan for the detection of infectious disease, has been approved and launched in Europe. LeukoScan is currently under regulatory review by the U.S. Food and Drug Administration. Immunomedics also has several other diagnostic imaging products and two therapeutic products in clinical trials.
This news release contains forward-looking statements that involve risks and uncertainties. The development and commercialization of the Company's imaging and therapeutic programs and products may differ materially from the Company's expectations. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development and marketing, actions of regulatory authorities concerning product approval, actions of government and private organizations concerning reimbursement, the impact of competitive products and pricing, and the results of further clinical trials.
SOURCE Immunomedics, Inc.
CONTACT: Robert Komenda, VP Finance, Administration & CFO of
Immunomedics, 973-605-8200 |
