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Josh, it's been a while since you posted.. anything new that you care to talk about?
09:09 AM ET 03/25/97
Immunomedics Reports Advances in More Accurate Breast Cancer Diagnosis
New ACS Guidelines May Increase Number of Unnecessary Biopsies
Reported Progress in Lymphoma Therapy
MORRIS PLAINS, N.J., March 25 /PRNewswire/ -- In a speech given yesterday at the Health Care Industry Conference of The New York Society of Security Analysts (NYSSA), Dr. David M. Goldenberg, Chief Executive Officer and Chairman of Immunomedics (Nasdaq: IMMU) reported on important advances in the diagnosis of breast cancer with the Company's diagnostic imaging agent, CEA-Scan(R), and in the therapy of non-Hodgkin's lymphoma (NHL) with the Company's therapeutic product, LymphoCide(TM).
More than 30 million mammograms are performed annually in the U.S., and as many as 500,000 lead to biopsies because of ambiguous findings. Most of these turn out not to be cancerous. With the recent new guidelines of the American Cancer Society suggesting annual mammograms for women beginning at age 40, the number of biopsies that prove noncancerous could increase by over 25%.
"Today, one of the most exciting of our investigational studies centers around women with suspicious mammograms. In studies performed by Drs. Dutzu Rosner and Hani Nabi of the State University of New York at Buffalo, CEA-Scan. has been found to correctly predict the absence of cancer in 92% of the cases, thus suggesting that biopsies of indeterminate mammograms may be reduced by about 75%," Dr. Goldenberg commented.
These results are scheduled to be presented in June at the annual meeting of the Society of Nuclear Medicine, in San Antonio, Texas. "If substantiated in further clinical trials, we are hopeful that CEA-Scan may become an important adjunct test to mammography in women presented with suspicious lesions, thus potentially reducing the burden of unnecessary and unpleasant biopsies," he added.
CEA-Scan is Immunomedics' leading cancer imaging product, currently available to doctors in the presurgical detection of colorectal cancer. However, colorectal cancer, which afflicts over 130,000 new patients in the U.S. annually, is only one of the many cancer types that express carcinoembryonic antigen (CEA), the protein targeted by CEA-Scan. According to Dr. Goldenberg, "Breast, lung, pancreas, ovarian, uterine and other cancers, totaling a cancer prevalence of more than 3.5 million, and more than 70% of all cancers express CEA. We are currently engaged in studying the use of CEA-Scan. in some of these other cancers."
The Company's clinical trials of its therapeutic antibody for non-
Hodgkin's lymphoma, as well as chronic and acute lymphocytic leukemias (CLL and ALL), have also provided some significant advances. Dr. Goldenberg described results of LymphoCide, the Company's lymphoma antibody labeled with the therapeutic radioisotope, iodine-131, showing remissions in patients who were chemotherapy-resistant. "In patients with NHL, CLL and ALL, LymphoCide has shown regressions within four weeks of treatment, and in some cases lasting up to 2 years. In one study conducted by Dr. Julie Vose of the University of Nebraska Medical Center, a 25% objective response rate was achieved in a drug-refractory group of advanced NHL patients, and it was found that all forms of NHL, including the aggressive type, were responsive to this therapy. From a competitive commercial perspective, Immunomedics' therapeutic appears to be active in the aggressive as well as the indolent forms of NHL, whereas the products of two other companies in more advanced clinical trials seem to be effective only in patients with the indolent (low-grade) type, which is the smaller patient population."
Dr. Goldenberg further stated that "The humanized antibody form of
LymphoCide appears to be similarly effective to the murine antibody first tested, and has even shown a complete remission in a man with acute lymphocytic leukemia who failed chemotherapy and bone marrow transplantation. It should be appreciated, moreover, that we are the only company with a companion lymphoma imaging agent, LymphoScan(TM), in advanced (Phase III) clinical trials, which could then be used to follow the course of our patients' responses."
In conclusion, he noted: "We are excited about these two significant advances in our imaging and therapy product-development programs, and will be expanding these trials in the next months."
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 for the detection of colorectal cancer, has been approved in both the U.S. and Europe and is being marketed by Mallinckrodt Group, Inc., and its European affiliate, Mallinckrodt Medical, B.V. The Company's second diagnostic imaging product, LeukoScan., was approved recently in Europe for the diagnosis of osteomyelitis (bone infection). The Company also has filed an application for market approval of LeukoScan in the United States with the Food and Drug Administration. Immunomedics also has several other diagnostic imaging products and two therapeutic products in clinical trials.
To receive Immunomedics' latest news and other corporate developments via fax at no cost, please call 1-800-PRO-INFO. Use company code IMMU.
This news release contains forward-looking statements that involve risk 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, Chief Financial Officer of Immunomedics,
201-605-8200; or General Info: Paul Henning, Analyst Info: Brian Gill, or Media Info: Deanne Eagle, all of The Financial Relations Board, 212-661-8030/
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