Epratuzumab Combined With Clofarabine and Cytarabine Produced a Complete Response Rate of 50% Clofarabine and Cytarabine Demonstrated a Complete Response Rate of 17% in a Previous Study ATLANTA, Dec. 10, 2012 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU),a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that adult patients with relapsed or refractory acute lymphocytic leukemia (ALL) reported a complete response (CR and CRi) rate of 50% after receiving one cycle of treatment with epratuzumab in combination with the chemotherapy agents, clofarabine and cytarabine. Results from this Phase II S0910 study conducted by the Southwest Oncology Group (SWOG) of the National Cancer Institute (NCI) were presented at the 2012 Annual Meeting of the American Society of Hematology by Anjali S. Advani, MD, Principal Investigator and staff physician in the Department of the Hematologic Oncology and Blood Disorders at Cleveland Clinic's Taussig Cancer Institute, Cleveland, OH. In addition to Cleveland Clinic, other clinical research centers participating in this multicenter trial include City of Hope National Medical Center, Duarte, CA; Stanford University School of Medicine, Stanford, CA; University of Mississippi, Jackson, MS; University of Rochester Medical Center, Rochester, NY; Baylor College of Medicine, Houston, TX; Fred Hutchinson Cancer Research Center, and SWOG Statistical Center, Seattle, WA. SWOG had previously reported a CR rate of 17% in adult patients with ALL using only the combination of clofarabine and cytarabine. Because virtually all immature B cells express CD22, which is the target of the Company's proprietary humanized antibody, epratuzumab, the NCI-study group wanted to evaluate the CR rate of combining the anti-CD22 antibody with the two chemotherapeutic agents. Twenty patients were initially accrued into the study to test whether the CR rate is sufficiently high to warrant further investigation. After at least 2 complete responders were observed in the first 20 patients, an additional 12 patients were accrued.
Among the 32 eligible patients evaluated, the overall CR rate was 50% (95% CI 32-68%), including 10 CRs and 6 CRis. The null response rate in this protocol was 10%, and the P-value comparing 50% to 10% is 1.2 x 10 -8 ( P=0.000000012).The median overall survival for the 32 eligible patients with follow-up information was 4 months. Only 5 patients who achieved CR/CRi had their bone marrow tested for minimal residual disease (MRD). Of these, only 1 patient achieved a significant MRD response and this patient survived 11 months. "We are very pleased with the encouraging complete response rate reported by SWOG," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We continue to add value to epratuzumab by supporting its use in oncology indications by outside, independent investigators. The anti-CD22 antibody will be evaluated in a large multicenter European trial by the IntreALL Inter-European study group in combination with chemotherapy in pediatric patients with relapsed ALL, using event-free survival as the primary endpoint," added Ms. Sullivan. 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, cytokines 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™) method 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 209 active patents in the United States and more than 400 foreign patents, 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, potential collaborations, 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 any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab 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.
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