New Data From EMBLEM(TM) Study Show Pipeline Drug Epratuzumab Provided Significant Efficacy for Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus
Statistically significant* and clinically meaningful differences of the epratuzumab 600 mg weekly and 1,200 mg every other week dose groups compared to the placebo group were achieved, with responder rates twice those of placebo
Treatment differences were observed as early as week 8, with further improvement to week 12
Epratuzumab 600 mg weekly was associated with greater BILAG improvement (from A/B to C/D) than placebo in affected body systems, with particularly prominent efficacy in cardiorespiratory and neuropsychiatric systems
ROME, June 16, 2010 (GLOBE NEWSWIRE) -- UCB (EURONEXT:UCB) and Immunomedics Inc. (Nasdaq:IMMU) announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Data presented at the European League Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEMTM, showed the clinical efficacy of epratuzumab in patients with SLE.
"We are very encouraged by the findings of this new study which demonstrate that in a patient population with predominantly severe disease activity, epratuzumab is improving patients' health as quickly as week 12, with the emergence of improvements as early as week 8," commented lead study investigator Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, UCLA. He added, "In a short study, such as this one, seeing this level of patient improvement so rapidly is a hopeful sign of the drug's potential to become an effective new treatment option."
EMBLEMTM was a 12-week, multicenter, phase IIb, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of epratuzumab, and to define a dose and regimen in patients with moderate to severe SLE. The primary efficacy measure in EMBLEMTM was a combined response index endpoint including several indices of SLE disease activity, primarily emphasizing BILAG**.
In the EMBLEMTM study, combined responder index rates were numerically superior in all epratuzumab groups than in the placebo group, reaching statistical significance in the epratuzumab 600 mg weekly group (P=0.0265*) and the combined group of all 74 patients who received a cumulative dose of 2,400 mg (P=0.0239*) during the 12-week treatment cycle. In both these groups, responder rates were twice those of placebo.
Based on analysis of improvement in BILAG 2004 by body system in EMBLEMTM, most patients had symptom reduction or absence of active disease within specific body systems after treatment with epratuzumab. Efficacy was particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve. This BILAG analysis reported the results for the BILAG improvement component of the combined response index in body systems for which a sufficient number of patients per treatment group had baseline disease activity that allowed an assessment of response. These systems were: musculoskeletal, mucocutaneous, cardiorespiratory, neuropsychiatric, constitutional and renal.
"Achieving a BILAG improvement without worsening, especially at an early timepoint such as week 12, is encouraging, as the BILAG 2004 evaluates nine different organ systems affected by SLE, including constitutional, mucocutaneous, neuro-psychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and haematological. In lupus, a disease that has not seen a new drug approved in over fifty years, epratuzumab shows encouraging signs of being able to improve patient lives in this devastating and life altering disease," said Kenneth Kalunian, M.D. Associate Director of the Center for Innovative Therapy, Professor in the Division of Rheumatology, Allergy and Immunology in the School of Medicine at UCSD.
Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.
Epratuzumab is a humanized monoclonal antibody targeting CD22 and modulating B-cell activity. Although the exact role of CD22 is not fully understood, it is considered to be a regulator of B-cell function. B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage. Epratuzumab is an anti-B-cell therapeutic, because of its ability to modulate B-cell function without depleting a large portion of these lymphocytes.
* p values were not adjusted for multiple comparisons
**BILAG (British Isles Lupus Assessment Group) is a comprehensive scoring system for assessing both current SLE disease activity and changes in that activity since the patient was last seen.
Epratuzumab is a humanized anti-CD22 monoclonal antibody under investigation for the treatment of SLE. CD22 is a B cell specific surface protein that is considered to be involved in B-cell function. The product was licensed to UCB from Immunomedics. Under the license agreement, UCB owns the rights and is responsible for the clinical development, and commercialization of epratuzumab in all autoimmune disorders including SLE.
In EMBLEMTM patients were randomized to 1 of 6 intravenous regimens: placebo (PBO), epratuzumab cumulative dose (cd) 200, 800, 2400, or 3600 mg in equal divided doses using 2 every other week (EOW) infusions or epratuzumab cd 2400 mg delivered as 4 equal infusions 1 week apart. Concomitant oral corticosteroids (CS) and immunosuppressives (IS) were stable for at least 5 and 28 days, respectively, prior to first study drug infusion. Primary endpoint was responder rate on a combined index of clinical disease activity at week 12 (defined as reduction of all baseline (BL) BILAG 2004 A to B/C/D and BL BILAG B to C/D, no BILAG worsening in other organ systems, and no deterioration in SLEDAI or physician global assessment [VAS]), with no CS, IS and antimalarials increase over BL dose. The study was not powered to detect statistical differences between treatment arms.
About systemic lupus erythematosus (SLE)
SLE, commonly referred to as lupus, is a chronic and potentially fatal autoimmune disease with a variable and unpredictable course. Antibodies are generated against the body's own nuclear proteins causing the immune system to attack its own cells and tissues resulting in inflammation and tissue damage. This can occur in any part of the body, but most often targets the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system.
Lupus is characterized by periods of flares, or exacerbations, interspersed with periods of improvement or remission. The Lupus Foundation of America estimated that between 1.5-2 million Americans have a form of lupus, 90 percent of whom are women. Symptoms and diagnosis occur most often between the ages of 15 and 45. In the U.S., lupus is more common in African Americans, Latinos, Asians, and Native Americans than in Caucasians.
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 9 000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol:UCB).
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 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 149 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 press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Forward looking statements relating to Immunomedics, Inc.
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.