SAN DIEGO, Nov. 15 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a leading biopharmaceutical company focused on developing monoclonal antibodies, today reported that patients with primary Sjogren’s syndrome, an autoimmune disease that currently affects between 2 to 4 million Americans, retained clinical benefits six months after being treated with epratuzumab. The results were presented at the 2005 annual scientific meeting of American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) by Dr. Serge D. Steinfeld, Professor of Medicine, Department of Rheumatology, Erasme University Hospital, Brussels, Belgium.
The clinical trial was an open-label, non-randomized, two-center Phase I/II study to assess feasibility, safety, and early evidence of efficacy in fifteen patients with primary Sjogren’s syndrome. Epratuzumab, a recombinant humanized antibody against CD22 expressed on B-lymphocytes, was administered intravenously in about one hour, every other week, for four doses of 360mg/m2 each. Patients were then evaluated twenty-four hours, four weeks, twelve weeks and six months post therapy. Epratuzumab therapy was associated with a mean decrease in circulating B-cells of 33% during the six- month evaluation. No immunogenicity was observed, and 1 patient experienced a serious drug- related infusion reaction, which resolved completely with no further recurrence of symptoms.
Efficacy was evaluated in four categories: tear production, unstimulated salivary flow, fatigue and laboratory analysis of erythrocyte sedimentation rate or IgG levels. Responders were defined as patients who have demonstrated improvement of 20% or more in two out of the four domains. At 20% level of improvement, the responder rates were between fifty to sixty percent throughout the entire six-month evaluation period. At 30% level of improvement, the rates decreased slightly to forty to fifty percent. At 50% level of improvement, the responder rates ranged from ten to forty percent, depending on the evaluation time point. These results were based on all patients who entered the study, but if the analysis is calculated based on the number of patients who were evaluable at the various time-points, then the responses were 9/10, 7/10, and 6/10 patients at 6 months for the 20%, 30% and 50% levels of improvement, respectively.
“These initial efficacy results suggest that epratuzumab is a promising therapy in patients with active primary Sjogren’s syndrome. Further controlled, blinded, studies to confirm these early efficacy results are warranted,” commented Serge D. Steinfeld, M.D., Ph.D., principal investigator of the study. Preliminary results from this study had previously been reported (http://www.immunomedics.com/news_pdf/2005_PDF/PR06102005.pdf).
About Epratuzumab
Epratuzumab is a humanized monoclonal antibody that targets CD22 antigen, found on the surface of B-lymphocytes, a type of white blood cell. Epratuzumab is being evaluated in patients with Sjogren’s syndrome and is also Immunomedics’ lead product candidate in two pivotal Phase III trials for the treatment of patients with moderate and severe systemic lupus erythematosus (SLE). The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE. Epratuzumab has also demonstrated good safety, tolerability, and clinical effect in more than 340 patients with non-Hodgkin’s lymphoma, resulting in reports published in The Journal of Clinical Oncology and Clinical Cancer Research.
About Sjogren’s Syndrome
Sjogren’s syndrome is a chronic autoimmune syndrome characterized by lymphocyte infiltration of salivary glands, resulting in symptomatic eye and mouth dryness. Sjogren’s syndrome can be associated with extraglandular presentations, such as musculoskeletal features including fatigue and fibromyalgia, in nearly 50% of patients, and fewer patients complain of arthralgias. According to the Sjogren’s Syndrome Foundation, the condition affects approximately two million to four million Americans, mostly middle-age women.
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, 973-605-8200, extension 123, or ccheng@immunomedics.com
Web site: http://www.immunomedics.com/
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