* Two Phase III Studies, EMBODY(TM) 1 and 2, Underway for Pipeline Drug Epratuzumab
* Phase III Program Follows Positive Phase IIb Study EMBLEM(TM), Which Showed That Epratuzumab Reduced Disease Activity Over a 12-Week Treatment Period
MORRIS PLAINS, NJ, USA and BRUSSELS, BELGIUM | December 14, 2010 | Immunomedics Inc. (Nasdaq:IMMU – News) and UCB (EURONEXT:UCB) today announced the enrollment of the first patient into EMBODY(TM) 1, one of two pivotal Phase III studies of epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE). Patient enrollment for EMBODY(TM) 2 has also begun.
"We are pleased to announce the launch of our Phase III program with epratuzumab, which marks UCB’s intent to develop this compound for such a severe disease," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer of UCB. She added, "The consistency of improvements demonstrated by epratuzumab in the clinical studies to-date is an encouraging platform to start the next phase of trials, and is a hopeful sign of the drug’s potential to become an effective new treatment option for lupus."
Both studies (EMBODY(TM) 1 and EMBODY(TM) 2) are multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in patients with moderate to severe SLE. Each study will last a maximum of 54 weeks and will randomize 780 subjects in the study, with approximately 130 planned investigational sites per study. The Phase III program has undergone the relevant regulatory advice procedures.
The primary objective of the studies is to confirm the clinical efficacy of epratuzumab in the treatment of patients with moderate to severe general SLE, in addition to continuing standard of care treatments.
The results from the Phase IIb study, EMBLEM(TM), showed that all epratuzumab doses, which ranged from 200mg to 3,600mg cumulative dose administered during one 12-week treatment cycle, had numerically superior response rates compared to placebo at week 12. For patients receiving epratuzumab at a cumulative dose of 2,400mg, there were meaningful and statistically significant* reductions in SLE disease activity, with responder rates more than double those of placebo.
The EMBLEM(TM) results showed that in a patient population with predominantly high disease activity, epratuzumab improved patients’ health at week 12, with the emergence of improvements as early as week 8.
Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.
* This study was not powered to detect statistical differences between treatment arms (p values were not adjusted for multiple comparisons and are based on an exploratory post-hoc analysis)
Reference
1. Arthritis and Rheumatism 2010; 62(10): S605. ACR 2010 American College of Rheumatology (ACR) Annual Scientific Meeting, November 7–11, 2010, Atlanta, GA, USA.
About Epratuzumab
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. 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.
About EMBLEM(TM)
In EMBLEM(TM), 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 and 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.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in over 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (Euronext:UCB.BR).
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. 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 154 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.
SOURCE: Immunomedics Inc.
Post Views: 43
* Two Phase III Studies, EMBODY(TM) 1 and 2, Underway for Pipeline Drug Epratuzumab
* Phase III Program Follows Positive Phase IIb Study EMBLEM(TM), Which Showed That Epratuzumab Reduced Disease Activity Over a 12-Week Treatment Period
MORRIS PLAINS, NJ, USA and BRUSSELS, BELGIUM | December 14, 2010 | Immunomedics Inc. (Nasdaq:IMMU – News) and UCB (EURONEXT:UCB) today announced the enrollment of the first patient into EMBODY(TM) 1, one of two pivotal Phase III studies of epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE). Patient enrollment for EMBODY(TM) 2 has also begun.
"We are pleased to announce the launch of our Phase III program with epratuzumab, which marks UCB’s intent to develop this compound for such a severe disease," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer of UCB. She added, "The consistency of improvements demonstrated by epratuzumab in the clinical studies to-date is an encouraging platform to start the next phase of trials, and is a hopeful sign of the drug’s potential to become an effective new treatment option for lupus."
Both studies (EMBODY(TM) 1 and EMBODY(TM) 2) are multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in patients with moderate to severe SLE. Each study will last a maximum of 54 weeks and will randomize 780 subjects in the study, with approximately 130 planned investigational sites per study. The Phase III program has undergone the relevant regulatory advice procedures.
The primary objective of the studies is to confirm the clinical efficacy of epratuzumab in the treatment of patients with moderate to severe general SLE, in addition to continuing standard of care treatments.
The results from the Phase IIb study, EMBLEM(TM), showed that all epratuzumab doses, which ranged from 200mg to 3,600mg cumulative dose administered during one 12-week treatment cycle, had numerically superior response rates compared to placebo at week 12. For patients receiving epratuzumab at a cumulative dose of 2,400mg, there were meaningful and statistically significant* reductions in SLE disease activity, with responder rates more than double those of placebo.
The EMBLEM(TM) results showed that in a patient population with predominantly high disease activity, epratuzumab improved patients’ health at week 12, with the emergence of improvements as early as week 8.
Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.
* This study was not powered to detect statistical differences between treatment arms (p values were not adjusted for multiple comparisons and are based on an exploratory post-hoc analysis)
Reference
1. Arthritis and Rheumatism 2010; 62(10): S605. ACR 2010 American College of Rheumatology (ACR) Annual Scientific Meeting, November 7–11, 2010, Atlanta, GA, USA.
About Epratuzumab
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. 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.
About EMBLEM(TM)
In EMBLEM(TM), 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 and 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.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in over 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (Euronext:UCB.BR).
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. 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 154 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.
SOURCE: Immunomedics Inc.
Post Views: 43
