-- Subcutaneous Injections of Low-Dose Veltuzumab Produced High Objective Response Rate as a Single Agent --
-- Final Results From Phase I/II Study Presented at the 55th Annual Meeting of the American Society of Hematology --
NEW ORLEANS, Dec. 9, 2013 (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 veltuzumab, administered subcutaneously as a single agent, produced an overall objective response rate of 49% in 47 evaluable patients with relapsed immune thrombocytopenia (ITP), including 15 patients (32%) who reported a complete response.
For the 23 patients who responded, median time to relapse from initial veltuzumab dose was 9.2 months, with 11 patients (48%) maintaining their response for more than 1 year. Veltuzumab showed activity across all dose levels tested, including the lowest dose of 80 mg x 2, and was active in patients with limited disease duration of 1 year or less, as well as in more heavily pretreated patients with chronic refractory disease.
It is of interest to note that 9 patients with the chronic disease had previously received thrombopoietin receptor (TPO-R) agonists, such as eltrombopag and romiplostim, which are the newest approved drugs for patients with chronic ITP who are refractory to other treatments. Out of these 9 patients, 2 had a complete response, one lasted for more than 1 year while the other is still ongoing at 4.6 months.
"We are very pleased with these promising results. The fact that some patients relapsed to TPO-R agonists responded to veltuzumab is particularly encouraging," commented Cynthia L. Sullivan, President and Chief Executive Officer. "We are currently evaluating various options for further clinical development of veltuzumab in this and other autoimmune disease indications, as well as in oncology, including licensing arrangements and collaborations with outside study groups," Ms. Sullivan added.
Results from this multicenter study were presented by Howard A. Liebman, MD, of the Jane Anne Nohl Division of Hematology, Keck School of Medicine, University of Southern California, Los Angeles, CA. Other participating centers included Division of Pediatric Hematology/Oncology, New York Presbyterian Hospital/Weill Cornell Medical College, New York, NY, and Georgia Cancer Specialists, Atlanta, GA.
A total of 50 patients with relapsed ITP, 36 of which had the disease for more than 1 year, were enrolled to receive 2 veltuzumab doses at 80, 160 or 320 mg administered 2 weeks apart or 320 mg per dose given once-weekly for 4 weeks. Treatments were well tolerated with no serious adverse events reported. B-cell depletion occurred after the first dose, even at the 80 mg level.
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. Our lead product candidate, epratuzumab, is currently in two Phase III clinical trials in lupus. In oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab labeled with a radioisotope in advanced pancreatic cancer patients. Other solid tumor therapeutics in Phase II clinical development include 2 antibody-drug conjugates, labetuzumab-SN-38 (IMMU-130) and TROP-2-SN-38 (IMMU-132). 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. DNL™ is being used particularly to make bispecific antibodies targeting cancers and infectious diseases as a T-cell redirecting immunotherapy, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies. We believe that our portfolio of intellectual property, which includes approximately 238 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. Our strength in intellectual property has resulted in the top-10 ranking in the 2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and Pharmaceuticals category. 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 UCB for the further development of epratuzumab 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.