MORRIS PLAINS, N.J., May 15, 2009 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that adding epratuzumab to rituximab and combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) produced significant overall response including complete response in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Results of this final analysis were released by the Mayo Clinic, Rochester, MN, on May 14 as part of the 2009 Annual Meeting of the American Society of Clinical Oncology. Epratuzumab is Immunomedics' proprietary humanized anti-CD22 monoclonal antibody that has been studied in over 500 patients with non-Hodgkin's lymphoma.
The goal of this multicenter, open-labeled, Phase II study, led by Dr. Ivana Micallef of the Mayo Clinic, was to assess efficacy with event-free survival (EFS) at 12 months as the primary endpoint. Secondary endpoints include response rate, time to progression and safety.
Eighty eligible patients with previously untreated DLBCL received epratuzumab at 360 mg/m(2), followed by rituximab at 375 mg/m(2), and a standard dose of CHOP every 3 weeks for 6 cycles. Most patients (80%) had the advanced stages of the disease, 51% of the patients were in the high-risk category. Moreover, 73% of patients had an elevated blood level of lactate dehydrogenase, which indicates the presence of fast-growing tumors.
Overall, 94% of patients responded to ER-CHOP, including 71% complete responses and 23% partial responses. The 12-month and 24-month EFS rates were 79% and 69%, respectively. Patients were subdivided into two groups based on their International Prognostic Index (IPI) scores. A higher IPI score (3 to 5) predicts a patient having a poorer chance of being cured of their aggressive lymphoma, but this subgroup of patients responded equally well to ER-CHOP, producing a 67% EFS rate at 24 months as compared to 72% from the low-risk patients.
"We believe these encouraging results, especially in the high-intermediate and high-risk IPI subgroups of patients, should be confirmed in a randomized Phase III study in comparison to standard R-CHOP therapy," commented Cynthia L. Sullivan, President and CEO of Immunomedics, Inc. "We are discussing this prospect with a National Cancer Institute-sponsored study group," Ms. Sullivan added.
About Diffuse Large B-Cell Lymphoma
According to the American Cancer Society, in 2009, an estimated 65,980 new cases of non-Hodgkin's lymphoma will be diagnosed and about 19,500 Americans will die from the malignancy. Diffuse large B-cell lymphoma (DLBCL) is an aggressive subtype of NHL, which comprises about 33% of the disease in the United States, making it the most common type of NHL in this country. Originated in the lymph nodes, this lymphoma can spread rapidly in the body. DLBCL can affect any age group, but occurs mostly in older people. About 40% to 50% of DLBCL patients are cured with current therapy.
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 134 patents issued in the United States and more than 300 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.