MORRIS PLAINS, N.J., May 13, 2010 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that clinical trial results on epratuzumab, the anti-CD22 humanized monoclonal antibody licensed to UCB SA, Brussels, for autoimmune disease indications, from the Phase IIb study in patients with lupus, will be presented in four posters sessions and one published abstract. These presentations will occur at the 2010 annual Congress of the European League Against Rheumatism (EULAR), June 16 – 19, 2010, in Rome, Italy. In the second half of 2010, UCB will initiate two Phase III studies of epratuzumab for the treatment of patients with moderate and severe lupus.
The schedule of the poster sessions, followed by key findings, are listed below:
- "Epratuzumab demonstrates clinically meaningful improvements in patients with moderate to severe systemic lupus erythematosus (SLE): Results from EMBLEM™, a Phase IIb study" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]
"Compared with placebo responder rate (21.1%), responder rates were statistically greater in epratuzumab 2400 mg (600 mg weekly) (45.9%; P=0.03) and 2400 mg combined groups (40.5%; P= 0.02); and showed clinically meaningful improvement in the 2400 mg (1200mg every-other-week group.)"
- "BILAG-measured improvement in moderately and severely affected body systems in patients with systemic lupus erythematosus (SLE) by epratuzumab: Results from EMBLEM™, a Phase IIb study" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]
"Treatment with epratuzumab 600 mg weekly during a 12-week cycle provided greater BILAG improvement over placebo in disease activity in all affected body systems. Efficacy was particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve."
- "The effects of the anti-CD22 monoclonal antibody epratuzumab on peripheral blood B cells and immune responses in vivo and immunoglobulin production in vitro" [Saturday, June 19, 10:15 a.m. – 12:00 p.m.]
"Epratuzumab treatment caused a reduction in B cells but had no effect on the capacity to raise antibody response to challenge antigens in Cynomolgus monkeys in vivo."
- "Impact of systemic lupus erythematosus on patients' employment, family relationships, and overall well-being" [Thursday, June 17 & Friday, June 18, 12:00 p.m. – 13:45 p.m., Saturday, June 19, 10:15 a.m. – 12:00 p.m.]
Also accepted for publication in the abstract book is "The effects of the anti-CD22 monoclonal antibody epratuzumab on B cell surface proteins". Topic: "03. Humoral aspects – autoantibodies".
"Epratuzumab stimulated rapid internalization of its target, CD22, on human peripheral blood B cells in vitro but had no consistent effect on a range of other B cell markers. This could lead to modulation of B cell functional responses that are regulated specifically by CD22, which may be relevant in the context of SLE."
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily 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 also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, 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. We believe that our portfolio of intellectual property, which includes approximately 149 patents issued in the United States and more than 375 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at 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 partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer 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.
CONTACT: Immunomedics, Inc.
Dr. Chau Cheng, Associate Director, Investor Relations &
Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com
