Long-Term Efficacy and Safety Results of Epratuzumab in Lupus Presented at Rheumatology Conference
WASHINGTON, Nov. 12, 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 with moderate-to-severe lupus who had received continued cycles of epratuzumab therapy maintained improvements or further improved their lupus disease activity over a timeframe of approximately 4 years. Importantly, lower levels of median corticosteroid use were also maintained throughout the study.
Results from this open-label, single-arm extension study of the Phase III ALLEVIATE trials were reported by clinical investigators at the 2012 American College of Rheumatology Annual Scientific Meeting in Washington DC. Immunomedics has licensed the rights to the development and commercialization of epratuzumab to UCB in all autoimmune diseases.
A total of 29 patients who had previously enrolled in the ALLEVIATE trials received 12-week cycles of epratuzumab treatment in the extension study, with each cycle consisting of two infusions at 360 mg/m2 on day 1 and day 8. Assessments of sustained efficacy and tolerability of epratuzumab were made using the British Isles Lupus Assessment Group (BILAG) index, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), corticosteroid use, and B-cell counts. Results were compared to values at baseline in the ALLEVIATE trials.
Median corticosteroid dose decreased from the ALLEVIATE baseline level of 21 mg/day to 7.5 mg/day by the start of the extension study. Moreover, the number of patients receiving a steroid dose of more than 20 mg/day decreased from 15 to 1. These lower doses were maintained or further reduced throughout the extension study.
Median BILAG total scores at the start of ALLEVIATE was 17, and decreased to 12 at the end of the extension study. Improvements in median BILAG total scores were maintained or decreased through week 204 of the extension study, with most BILAG A/B grades improved to C/D at least once during the extension study. Epratuzumab had a tolerable safety profile, and no new safety signals were identified.
Commenting on these encouraging results, Cynthia Sullivan, President and Chief Executive Officer remarked, "This extension study could provide important long-term efficacy and safety data in support of potential filings to regulatory authorities. Importantly, the decrease in corticosteroid levels during epratuzumab therapy could potentially spare patients from the long-term adverse effects of steroid treatment."
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(TM) (DNL(TM)) 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
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.
CONTACT: For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
Posted: November 2012