MORRIS PLAINS, N.J., April 24 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a biopharmaceutical company focused on developing monoclonal antibodies, today announced that results from their phase II study of epratuzumab in systemic lupus erythematosus (SLE) were published on-line in Arthritis Research & Therapy. Entitled "Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus," and authored by T. Dorner, J. Kaufmann, W.A. Wegener, N. Teoh, D.M. Goldenberg and G.R. Burmester, the article can be accessed at http://arthritis-research.com/content/8/3/R74.
Fourteen patients with moderately active SLE were enrolled in this open- label, single-center study. At the beginning of the study, total baseline BILAG (British Isles Lupus Assessment Group) scores for the group ranged from 6 to 12. In all 14 patients at some point during the study, total BILAG scores decreased by 50% or more. Specifically, at 6 weeks of follow-up, 77% of patients had their BILAG scores decreased by 50% or more, with 92% having decreases of various amounts continuing to at least 18 weeks. Almost all patients (93%) experienced improvement in at least one BILAG B- or C-level disease activity at 6, 10, and 18 weeks. Additionally, 3 patients with multiple BILAG B involvement at baseline had completely resolved all B-level disease activities by 18 weeks.
Patients received 360 mg/m2 epratuzumab intravenously every 2 weeks for 4 doses with analgesic/antihistamine premedication (but no steroids) prior to each dose. Evaluations, performed at 6, 10, 18 and 32 weeks (6 months post- treatment), included safety, SLE activity (BILAG score), blood levels of epratuzumab, B and T cells, immunoglobulins, and human anti-epratuzumab antibody (HAHA) titers.
Epratuzumab was well tolerated, with a median infusion time of 32 minutes. Drug serum levels were measurable for at least 4 weeks post-treatment and detectable in most samples at 18 weeks. B-cell levels decreased by an average of 35% at 18 weeks and remained depressed at 6 months post-treatment. Changes in routine safety laboratory tests were infrequent and without any consistent pattern, and there was no evidence of immunogenicity, or significant changes in T cells, immunoglobulins, or autoantibody levels.
Results from this study were presented at the 68th annual scientific meeting of American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) (please refer to http://www.immunomedics.com/news_pdf/2004_PDF/PR10192004.pdf).
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: Immunomedics Inc. 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 of Immunomedics Inc., +1-973-605-8200, extension 123, orccheng@immunomedics.com
Web site: http://www.immunomedics.com/http://www.immunomedics.com/news_pdf/2004_PDF/PR10192004.pdf/http://arthritis-research.com/content/8/3/R74/
Company News On-Call: http://www.prnewswire.com/comp/113121.html /
