Healthcare Industry News: rituximab
News Release - December 4, 2006
Study Showed Epratuzumab in Combination with Rituximab and Chemotherapy is Safe, Tolerable, and Active in Aggressive LymphomaMORRIS PLAINS, N.J., Dec. 4 (HSMN NewsFeed) -- Immunomedics, Inc. (Nasdaq: IMMU ), a biopharmaceutical company focused on developing monoclonal antibodies, today reported that adding epratuzumab to rituximab and combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) to treat patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) produced promising results. This study was published in an on-line article in Cancer.
Fifteen patients with previously untreated DLBCL were enrolled in this Phase II study led by Dr. Ivana Micallef at the Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN. Thirteen of 15 patients responded (87%), including 10 complete responses (67%) and 3 partial responses (20%). At a median follow-up of 30 months, 13 of 15 patients remained alive. The 1-year progression-free survival (PFS) and overall survival (OS) rates were 93% and 100%, respectively, and the 2-year PFS and OS rates were 86% and 86%, respectively.
"To our knowledge, this is the first study to combine epratuzumab with chemotherapy. The results from this pilot study showed that ER-CHOP is a safe and effective regimen for the treatment of patients with newly diagnosed DLBCL," remarked Dr. Ivana Micallef, senior author. "These encouraging initial results have led us to conduct a Phase II multicenter study using ER-CHOP for newly diagnosed DLBCL under the auspices of the North Central Cancer Treatment Group, funded by the National Cancer Institute. The new trial is progressing very well in accrual," she added.
Patients received epratuzumab at 360 mg/m2, followed by rituximab at 375 mg/m2, and a standard dose of CHOP every 3 weeks for 6 to 8 cycles. Although, grade 3 or 4 neutropenia was observed in 14 patients (93%), or in 28 of 92 cycles (30%), only 3 patients developed grade 3 or more infection or fever. Eleven patients (73%) required dose reductions mainly secondary to grade 4 neutropenia. No grade 3 antibody infusion-related toxicity was reported.
Authored by I.N.M. Micallef, B.S. Kahl, M.J. Maurer, A. Dogan, S.M. Ansell, S.M. Ansell, J.P. Colgan, S. Geyer, D.J. Inwards, W.L. White and T.M. Habermann, the article entitled "A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma" can be accessed at http://www3.interscience.wiley.com/cgi- bin/abstract/113456987/ABSTRACT.
Epratuzumab is being studied in two NCI-sponsored clinical trials involving the Children's Oncology Group and the North Cancer Center Treatment Group, and is anticipated to expand to other study group trials in the future as the safety and efficacy results in such lymphoma and leukemia trials are reported. Two prior trials published in the Journal of Clinical Oncology in 2005 and 2006 showed that epratuzumab can be combined with rituximab safely, with a suggestion of improved complete and durable response rates in patients with indolent and aggressive NHL types.
About Diffuse Large B-Cell Lymphoma
According to the American Cancer Society, an estimated 365,000 Americans have non-Hodgkin's lymphoma (NHL). More than 58,000 new cases will be diagnosed in 2006 and about 18,840 people will die from the malignancy this year. Diffuse large B-cell lymphoma (DLBCL) is an aggressive subtype of NHL, which makes up 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 therapy.
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 recently 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. 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 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. 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 (including the timing and amount of contingent payments), 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.
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