WASHINGTON, Nov. 13, 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 patients receiving epratuzumab reported clinically meaningful improvements in health-related quality of life (HRQoL) that were sustained over approximately 4 years of treatment.
The study is the extension arm of the two ALLEVIATE trials, with 29 ALLEVIATE patients enrolled in the extension study to receive two infusions of 360 mg/m2 epratuzumab on day 1 and day 8 of 12-week cycles. Immunomedics has licensed the rights to the development and commercialization of epratuzumab to UCB in all autoimmune diseases. The effect of epratuzumab on HRQoL was measured using the 36-item Short Form Health Survey (SF-36).
SF-36 evaluates eight domains - physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). These domains are grouped into two summary scores, Physical and Mental Component Summary scores, PCS and MCS, respectively. Mean changes for PCS and MCS and each domain score were compared with baseline values in the ALLEVIATE trials and at the screening of the extension study. Minimum clinically important difference (MCID) for PCS and MCS is defined as improvements of 2.5 points or more, and 5.0 points or better for the eight domains.
At the beginning of the extension study, mean changes from ALLEVIATE baseline levels in SF-36 PCS and 5 domain scores (PF, RP, BP, GH and SF) met or exceeded MCID. Continued treatment with epratuzumab sustained these SF-36 domain score improvements from ALLEVIATE over approximately 4 years. Further improvement exceeding MCID was recorded in three domains (RP, BP, SF) at the last visit.
In addition, mean PCS and MCS scores increased throughout the extension study and the majority were higher than the ALLEVIATE scores of 31.8 and 42.2, respectively. Improvements in PCS scores exceeded MCID at all time points up to week 204. Mean scores for most of the eight domains of SF-36 showed continual improvement from the start of the ALLEVIATE trial to the end of the extension study.
"This is the second presentation at this year's ACR that demonstrated clinical benefits of epratuzumab treatment as reported by patients in the ALLEVIATE extension study," commented Cynthia Sullivan, President and Chief Executive Officer. "These improvements in health-related quality of life, as well as the reduction in steroid use reported earlier, are important to lupus patients. We look forward to our partner, UCB, reporting top-line data from its Phase III EMBODY™ trials," Ms. Sullivan added.
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 206 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.
For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123