updated 12/6/2010 5:15:19 AM ET 2010-12-06T10:15:19

ORLANDO, Fla., Dec. 5, 2010 (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 reported that combination treatment with milatuzumab, the first humanized anti-CD74 antibody in clinical testing, and veltuzumab, a second-generation humanized anti-CD20 antibody, resulted in therapeutic responses in heavily pretreated and rituximab-refractory non-Hodgkin's lymphoma (NHL) patients.

The goal of this Phase I/II trial being conducted at the Ohio State University Comprehensive Cancer Center is to determine the safety, tolerability, and overall response rate of adding milatuzumab to veltuzumab in patients with relapsed or refractory B-cell NHL after at least 1 prior therapy. At the time of reporting, 11 patients have been enrolled and received veltuzumab at 200 mg/m2 weekly combined with escalating doses of milatuzumab at 8, 16 and 20 mg/kg twice per week. Seven of the 11 patients were rituximab-refractory and 3 had prior autologous stem cell transplants. Four of 9 evaluable patients showed an objective response.

Dose escalation reached 16 mg/kg milatuzumab with no dose-limiting toxicities observed to date.  The primary observed toxicity of milatuzumab was infusion reactions, which were reversible. Accrual to the Phase I portion of the study is ongoing, and will be followed by a Phase II trial to further evaluate efficacy of the combination.

Results on other milatuzumab-based combination treatments were also presented at the meeting in two separate preclinical studies. Using a number of human lymphoma and leukemia cell lines, the first study, conducted by the Garden State Cancer Center in New Jersey, demonstrated that milatuzumab could significantly augment the efficacy of fludarabine and rituximab, two approved therapies for B-cell malignancies. 

In the second preclinical study, conducted by the Garden State Cancer Center and Coney Island Hospital, in New York, CD74, a receptor targeted by milatuzumab, was found to be present in acute myeloid leukemia (AML)patient specimens and in AML cell lines. Moreover, exposure of AML cell lines to interferon-gamma (IFN-y) increased the number of CD74 receptors, and resulted in improved activity of milatuzumab in 2 of 3 AML cell lines. These results suggest that combined IFN-y and milatuzumab may be useful for AML therapy.

Commenting on these results, Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics said, "Milatuzumab is the first anti-CD74 antibody in clinical studies, and we are pleased to see that it can complement and augment a number of existing cancer therapies, which may potentially broaden its use against a variety of cancers."

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) 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 154 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, Director, 
          Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com

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