MORRIS PLAINS, N.J., April 9, 2008 (PRIME NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that patient dosing has begun in a Phase I/II study of subcutaneously-administered veltuzumab in patients with CD20-positive non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL).
After receiving only a single subcutaneous injection of a low dose of 80 mg of veltuzumab, circulatory B-cell levels were reduced to less than 1% compared to baseline, indicating that veltuzumab, administered subcutaneously, is distributed in the body similar to the intravenous formulation and, furthermore, was well tolerated.
"This is an important milestone in the development of veltuzumab for the therapy of B-cell malignancies and autoimmune diseases. We believe veltuzumab is the first humanized anti-CD20 antibody tested in a clinical trial setting as a subcutaneous formulation," remarked Cynthia L. Sullivan, President & CEO. "Preliminary results from this study are planned for presentation at the American Society of Hematology's annual meeting in December 2008. Additionally, negotiations for the out-licensing of veltuzumab are in advanced stages," Ms. Sullivan said.
The purpose of this study is to determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously. The primary objective is to document the safety, tolerance and lack of immunogenicity of veltuzumab with this route of administration. The secondary objectives are to assess pharmacodynamics, pharmacokinetics, and to document evidence of efficacy in these patient groups.
Approximately 72 adult patients with documented CD20-positive NHL or CLL are planned for this open-label, multicenter study. Veltuzumab is being administered subcutaneously once every other week for a total of 4 injections, and patients are monitored during injections and at intervals over a 12-week post-treatment evaluation period.
About Veltuzumab
Veltuzumab, previously referred to as hA20, is a humanized monoclonal antibody having 90-95% human antibody sequences (derived from the Company's anti-CD22 humanized antibody, epratuzumab), and antigen-binding determinants with a similar binding site to rituximab, but having some chemical differences, and also having a longer binding to lymphoma cells. Enrollment has been completed in the Phase I/II trials in patients with low-grade NHL, where it was found that doses as low as 80 mg/m(2) administered weekly over 4 weeks has substantial complete responses (about 24%), with first infusions being very well tolerated over 2 hours and subsequent infusions being given in a little over 1 hour. So far, no evidence of an immune response to repeated administrations, and no serious adverse events related to the investigational drug, have been observed.
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 (www.ucb-group.com) 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 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 acute lymphoblastic leukemia in cooperation with National Cancer Institute Study Groups. In addition, the Company is conducting clinical trials with intravenous veltuzumab in patients with non-Hodgkin's lymphoma and immune thrombocytopenic purpura, (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. We believe that our portfolio of intellectual property, which includes approximately 116 patents issued in the United States and more than 290 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, patent protection, 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.