Healthcare Industry News: UCB
News Release - June 4, 2007
Repeated Radioimmunotherapy With 131I-Labetuzumab Appears Safe and Effective in Colorectal Cancer with Liver MetastasesInitial Phase II Study Results Presented at Society of Nuclear Medicine Annual Meeting
WASHINGTON, June 4 (HSMN NewsFeed) -- Immunomedics, Inc. (Nasdaq: IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that its anti-carcinoembryonic antigen (CEA) antibody, labetuzumab, labeled with the radioisotope, iodine-131, was found to be safe and active when given in two doses to patients with colorectal cancer that has metastasized to the liver. Dr. Johannes Meller of the University of Gottingen, Germany, reported results from this study in an oral presentation at the 54th Annual Meeting of the Society of Nuclear Medicine (SNM) in Washington, DC.
Forty colorectal cancer patients with liver metastases have been enrolled in this Phase-II study. After surgery to remove liver metastases, patients were screened for cancer by PET and CT scans. At the time of reporting, 32 patients were evaluated. Sixteen were found to be negative for cancer (the adjuvant group) after surgery while the other 16 patients were found to have evidence of recurrent disease (the non-adjuvant group).
Six weeks after liver surgery, both groups of patients received an initial dose of 40 - 50 mCi/m2 of 131I-labetuzumab, followed by a second infusion three months later. At the time of reporting, 62.5% of patients (10/16) in the adjuvant group remained disease-free. For the non-adjuvant group, 25% of patients (4/16) reported no cancer relapse.
"These initial results suggested that re-treatment with 131I-labetuzumab is safe, feasible and well accepted, with transient myelosuppression the principal and only adverse effect," commented Dr. Johannes Meller, Director of Nuclear Medicine, University of Gottingen, Germany, and lead author of the study presented. "In 2008, we plan to initiate a multicenter, randomized trial evaluating the radiolabeled anti-CEA antibody at repeated doses of 40 - 50 mCi/m2," he commented further.
In an early study, the German scientists reported a 5-year survival rate of 51.3% in 19 colorectal cancer patients who received a single dose of 131I- labetuzumab after surgery versus 7% of control patients who did not receive the antibody therapy, but only conventional therapies. Median overall survival from the first surgery was 68.0 months for the treatment group compared to 31 months for the control group. Results of this study were published in the September 20, 2005, issue of the Journal of Clinical Oncology.
About Colorectal Cancer
According to the American Cancer Society, about 153,760 Americans will be diagnosed with colorectal cancer in 2007. An estimated 52,180 people will die from the malignancy this year. The liver is the most common site of distant metastasis, affecting up to 60% of patients, and is the only metastatic site in 30% of patients. The 5-year survival rate for colorectal cancer patients with unresected liver metastases is close to 0%. With complete resection of liver metastases, a 5-year survival rate of 25% to 37% can be achieved. However, despite postsurgical adjuvant systematic or intrahepatic chemotherapy, cancer relapse occurs in approximately two thirds of resected patients, with more than one half first experiencing recurrence in the liver. Currently there is no established adjuvant therapy for the treatment of colorectal cancer patients after resection of liver metastases.
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. We have licensed our lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all autoimmune disease indications worldwide. We have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. UCB has development, manufacture and commercialization rights, and is responsible for all clinical trials evaluating epratuzumab for the treatment of patients with moderate and severe lupus. 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. The Company is conducting clinical trials with hA20 in patients with non-Hodgkin's lymphoma, epratuzumab as a potential therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer therapy and hCD74 as a therapy for patients with multiple myeloma. We believe that our portfolio of intellectual property, which includes approximately 108 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock and Lock (DNL) methodology, 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. For additional information on us, please visit our web site at http://www.immunomedics.com. The information on our website does not, however, form a part of this press release.
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), forecasts of future operating results, 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), our dependence on our licensing partner for the further development of epratuzumab for autoimmune indications, 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.
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