MORRIS PLAINS, N.J., Aug. 1, 2008 (PRIME NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, announced today that epratuzumab in combination with chemotherapy produced promising results in children with relapsed acute lymphoblastic leukemia (ALL), including 9 patients achieving a complete response. Results from this study were published in the August 1, 2008 issue of the Journal of Clinical Oncology, entitled "Chemoimmunotherapy reinduction with epratuzumab in children with acute lymphoblastic leukemia in marrow relapse: a Children's Oncology Group Pilot Study," by E.A. Raetz, M.S. Cairo, M.J. Borowitz, S.M. Blaney, M.D. Krailo, T.A. Leil, J.M. Reid, D.M. Goldenberg, W.A. Wegener, W.L. Carroll and P.C. Adamson.
Fifteen patients with first or later CD22-positive ALL marrow relapse were enrolled in this multicenter study. Epratuzumab was given intravenously first as a single agent at 360 mg/m2 twice weekly for two weeks, followed by 4 weekly doses of epratuzumab in combination with standard reinduction chemotherapy. Twelve patients were fully assessable for toxicity. In all but one assessable patient, surface CD22 antigen was not detected by flow cytometry on peripheral blood leukemic blasts within 24 hours of the 6-week treatment period, indicating effective targeting of leukemic cells by epratuzumab. Nine patients (75%) achieved a complete remission, of which 7 showed no residual disease.
"We are pleased with these encouraging results in children with ALL. The Children's Oncology Group (COG) is continuing to enroll patients into the ongoing Phase II portion of this study, and we look forward to their future results," remarked Cynthia L. Sullivan, president and CEO. "We continue to work with other oncology study groups to implement new clinical trials combining epratuzumab and veltuzumab," she added.
ALL is a cancer of the white blood cells, which normally fight infections in the body. According to the American Cancer Society, an estimated 3,040 children before age 20, which represents 23% of new cases, will be diagnosed with ALL in the United States in 2008 making ALL the most common cancer in children and adolescents. About 85% of ALL is B-cell ALL, and the most common subtype of B-cell ALL is B-precursor ALL. CD22 is expressed in more than 90% of childhood B-precursor ALL. Although the 5-year survival rate for ALL in children is 87%, the prognosis for a child with relapsed ALL remains poor.
This COG study led by Elizabeth Raetz, MD, pediatric oncologist at New York University, New York, was supported in part by grant CA-98543 from the National Cancer Institute. Part of this study was presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (http://www.immunomedics.com/news_pdf/2007_PDF/PR06042007A.pdf).
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. We have exclusively licensed our lead product candidate, epratuzumab, to UCB for the treatment of all autoimmune disease indications worldwide. Epratuzumab's most advanced clinical testing is for the treatment of systemic lupus erythematosus (SLE) and in non-Hodgkin's lymphoma (NHL). 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 have retained the rights for epratuzumab in oncology indications, and are advancing trials in lymphoma and in childhood ALL in cooperation with National Cancer Institute Study Groups. We have also licensed veltuzumab to Nycomed for non-cancer indications. In addition, Immunomedics retains full rights to develop, manufacture and commercialize veltuzumab either by itself, or through third-parties, in the field of oncology. The Company is conducting clinical trials with veltuzumab in patients with NHL, chronic lymphocytic lymphoma (CLL) and immune thrombocytopenic purpura (ITP), (90)Y-epratuzumab for the therapy of patients with lymphoma, (90)Y-hPAM4 combined with gemcitabine for pancreatic cancer therapy, and milatuzumab (anti-CD74 humanized antibody) as a therapy for patients with multiple myeloma, NHL, and CLL. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology 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. The Company is working to advance this new technology into clinical testing, advancing the prospects of a personalized cancer therapy strategy. We believe that our portfolio of intellectual property, which includes approximately 116 patents issued in the United States and more than 295 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website 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.