ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a leading biopharmaceutical company focused on developing monoclonal antibodies, announced today results of a trial conducted at eight centers in Europe testing the safety and response rates of its lead product, epratuzumab, in combination with rituximab in the treatment of patients with non-Hodgkin's lymphoma (NHL).
The multi-center trial enrolled a total of thirty two patients with follicular or indolent NHL who received four consecutive weekly infusions of 360 mg/m2 of epratuzumab followed by the same weekly schedule of 375 mg/m2 rituximab. Prior to joining this study, sixteen patients had received two or more chemotherapy regimens and eleven patients had rituximab therapy. Twenty patients, or 62%, achieved an objective response, including 25% with complete responses (CR/CRu) and 37% with partial responses. The median response duration was 16.5 months and the median time-to-progression was 11 months.
Further analysis using the Follicular Lymphoma International Prognostic Index (FLIPI), a new prognostic index specifically designed for follicular lymphoma patients, revealed that those patients having the lowest prognostic index scores, or best prognosis, had the best outcome. Specifically, at FLIPI scores of 0-1, there was an 82% (9/11) objective response rate and a complete response rate of 36% (4/11), with a median duration of response of 15.7 months and a median time-to-progression of 19.2 months.
"These results are encouraging regarding the potential of combination therapy involving CD22 and CD20 monoclonal antibodies in the treatment of patients with NHL, and confirm earlier results from a single-center trial at the NY Hospital-Cornell Medical Center where patients with good prognostic indices were studied," commented Cynthia L. Sullivan, President and Chief Executive Officer. "It appears that both antibodies have different mechanisms of action. We anticipate that the complete trial results, including patients with aggressive NHL, toxicity data, and longer follow-up, will be published in 2006," she commented further.
In addition to the two pivotal Phase III ALLEVIATE trials in patients with lupus, epratuzumab is currently being studied in patients with Waldenstrom's Macroglobulinemia, a rare, chronic type of lymphoma, and by the Children's Oncology Group (COG) of the National Cancer Institute (NCI) in children with acute lymphoblastic leukemia. The North Central Cancer Treatment Group, a national clinical research group sponsored by the NCI, also plans to evaluate epratuzumab in combination with rituximab and CHOP chemotherapy in aggressive NHL patients.
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, 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.
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, 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.
For More Information: Dr. Chau Cheng Associate Director, Investor Relations & Business Analysis (973) 605-8200, extension 123 ccheng@immunomedics.com
Immunomedics, Inc.CONTACT: Dr. Chau Cheng, Associate Director, Investor Relations & BusinessAnalysis, +1-973-605-8200, ext. 123, ccheng@immunomedics.com
Web site: http://www.Immunomedics.com//
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