Healthcare Industry News:  liver metastases 

Biopharmaceuticals Oncology

 News Release - June 2, 2006

Repeated Radioimmunotherapy With 131I-Labetuzumab in Colorectal Cancer With Liver Metastases Found Safe and Well-Tolerated in Initial Phase II Study

ATLANTA, June 2 (HSMN NewsFeed) -- Immunomedics, Inc. (Nasdaq: IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies, today reported that repeated use of its radiolabeled antibody against the carcinoembryonic antigen (CEA), 131I-labetuzumab, has been found to be safe and well-tolerated by patients with colorectal cancer that has metastasized to the liver. Results from this study were accepted for publication at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia.

Twelve patients have been enrolled in this Phase II study led by Dr. Torsten Liersch at the Department of General Surgery of the University of Gottingen, Germany. Within 2 months of surgery to remove liver metastases of colorectal cancer, patients received a first dose of 50 mCi/m2 of 131I-labetuzumab. Three months after the first radioimmunotherapy (RAIT), a second infusion of the radiolabeled, humanized, CEA-antibody was given in the same amount. Transient grade-4 myelosuppression occurred in 4 out of 12 patients after the first dose, but no cumulative toxicity was seen thus far in 7 patients who have received the second infusion. Complete bone marrow recovery was reported in all cases. At a median follow-up of 4 months, no cancer recurrence has been detected in the 12 patients enrolled to date. In all, a total of 15 patients will be enrolled in this study.

"We are pleased that a new study has been initiated to evaluate the effect of repeated dosing of 131I-labetuzumab in colorectal cancer patients and we look forward to learning more about the clinical effects," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "Since about two-thirds of patients with colorectal cancer metastases to the liver relapse after resection of these liver tumors, an adjuvant therapeutic, such as perhaps our 131I-labetuzumab, may prove useful in this setting of disseminated disease," she remarked.

This is a second trial conducted by the German researchers using 131I-labetuzumab for colorectal cancer patients with liver metastases. In the previous study, only one 131I-labetuzumab dose was given to colorectal cancer patients after surgery to remove liver metastases. Five-year survival was achieved by 51.3% of the 19 patients who received RAIT. Median overall survival from the first surgery was 68.0 months and median disease-free survival was 18.0 months. Results of this study had been published in the September 20, 2005, issue of the Journal of Clinical Oncology.

About Colorectal Cancer

According to the American Cancer Society, about 106,680 Americans will be diagnosed with colorectal cancer in 2006. An estimated 55,170 people will die from the malignancy this year. When the disease is detected early at a localized stage, the 5-year survival is 90%. However, only 39% of the cancer is diagnosed at this stage. After the cancer has spread to adjacent lymph nodes or organs, the 5-year rate drops to 68%. For all stages combined, the 5-year survival for patients with colorectal cancer is 64%. When the cancer has metastasized to distant tissues and organs, 5-year survival is only 10%.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. Our lead product candidate, epratuzumab, which development, manufacture and commercialization rights we have licensed to UCB, S.A. for the treatment of all autoimmune indications worldwide, is currently in two pivotal Phase III trials for the treatment of patients with moderate and severe lupus (ALLEVIATE A and B). At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. in the last 40 years. We believe that our portfolio of intellectual property, which includes approximately 90 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. Visit our web site at http://www.immunomedics.com . We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel dock and lock platform technology, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.


Source: Immunomedics

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