Study Reports Epratuzumab Affects B-Cells from Patients With Lupus in a Unique Manner
MORRIS PLAINS, N.J., Aug. 16, 2007 (PRIME NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported results from a study showing epratuzumab inhibits the activation of B-cells from patients suffering from systemic lupus erythematosus (SLE) but not normal subjects.
SLE or lupus is an autoimmune disease in which the immune system attacks the body's own tissues and organs. B-cells have been implicated in the cause of lupus and other autoimmune diseases. Epratuzumab is a humanized monoclonal antibody that targets the CD22 antigen found on B-cells. In our earlier Phase I/II study, epratuzumab was found to show activity and good safety in the treatment of patients with lupus.
This study is a follow-up to the Phase I/II trial aimed at understanding the mechanism of action of epratuzumab. The first part of the study analyzed the effect of epratuzumab on circulatory B-cell subsets in 12 patients treated in the Phase I/II study. Results showed that epratuzumab preferentially targets naive and transitional B-cells of these lupus patients, which we believe is a unique difference to other therapeutic antibodies.
The second part of the study investigated the effect of epratuzumab on the inhibition of the activation of B-cells taken from a second group of 11 patients with lupus and 7 normal subjects. Under all experimental conditions tested, epratuzumab stopped the over-activation of B-cells from SLE patients but not normal B-cells, when activated by certain immune stimulating agents.
"This differential regulation of normal versus lupus B-cells by epratuzumab supports the contention that this antibody may offer a new therapeutic option for patients with SLE, since enhanced B-cell activation is a hallmark of lupus," commented Professor Thomas Dorner, M.D., principal author of the publication.
"These results and those from our earlier Phase I/II study, which have to be confirmed in a larger trial, support the view that epratuzumab is effective in the treatment of patients with lupus and we look forward to the update by UCB on their clinical plans for epratuzumab in the fourth quarter of this calendar year," remarked Cynthia L. Sullivan, President & Chief Executive Officer.
Authored by A.M. Jacobi, D.M. Goldenberg, F.T. Hiepe, A. Radbruch, G.R. Burmester and T. Dorner, the article entitled "Differential effects of epratuzumab on peripheral blood B cells of SLE patients versus normal controls" was published online in Annals of the Rheumatic Diseases and can be accessed at http://ard.bmj.com/cgi/content/abstract/ard.2007.075762v1.
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 veltuzumab in patients with non-Hodgkin's lymphoma, epratuzumab as a potential therapeutic for patients with lymphoma and leukemia, (90)Y-epratuzumab for the therapy of patients with lymphoma, (90)Y-hPAM4 for pancreas cancer therapy and milatuzumab 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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Posted: August 2007