PRINCETON, N.J., May 12 Medarex, Inc.(Nasdaq: MEDX) announced today that it has initiated the Phase 2 clinicaldevelopment program of MDX-1100, a fully human monoclonal antibody thattargets CXCL10 (also known as IP-10), in ulcerative colitis (UC) andrheumatoid arthritis (RA). MDX-1100 could potentially treat UC and RA bysuppressing the inflammatory process characteristic of these diseases.
"Based on positive safety data in Phase 1 studies, we have initiatedpatient enrollment in Phase 2 studies that are designed to establishproof-of-concept," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice Presidentof Product Development at Medarex. "We are optimistic about the broadpotential of MDX-1100 to address a range of inflammatory diseases."
Patients in the Phase 2 randomized, double-blind, placebo-controlled,multi-center study in UC will be administered MDX-1100 at 10 mg/kg or placeboevery 2 weeks for a total of 4 doses. All patients will have active UC andwill continue standard UC therapy during the trial. The trial is expected toenroll 106 patients at multiple sites internationally. The primary endpointof the study is the response rate at 8 weeks. Clinical response is based onthe Mayo score, a composite endpoint that assesses stool frequency and theamount of bloody stool per day as recorded in a patient diary, physicianglobal assessment and the assessment of colon mucosal inflammation ascertainedby endoscopy.
Patients in the Phase 2 randomized, double-blind, placebo-controlled,multi-center study in RA will be administered MDX-1100 at 10 mg/kg or placeboevery 2 weeks for a total of 6 doses. All patients will have active RA whileon methotrexate. The trial is expected to enroll 70 patients at multiplesites in Europe. The primary endpoint of the study is the ACR20 response, acomposite endpoint that indicates a 20% improvement in RA signs and symptoms,at 12 weeks.
Medarex also announced that results from the MDX-1100 Phase 1 trials willbe presented at the Digestive Disease Week (DDW) meeting, being held May 17 -22, 2008 in San Diego. The following abstracts are expected to be the subjectof presentations at the DDW 2008 conference:
These presentations support the development of MDX-1100 for the treatmentof inflammatory diseases such as ulcerative colitis and rheumatoid arthritis.
MDX-1100 is a fully human antibody that targets CXCL10 (also known asIP-10), a chemokine expressed in association with multiple inflammatorydisease indications such as rheumatoid arthritis, inflammatory bowel diseaseand multiple sclerosis.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease of thecolon and is characterized by inflammation and ulceration of the lining of thecolon. Symptoms typically include bloody diarrhea and abdominal pain and insevere cases may require colectomy. According to the Crohn's & ColitisFoundation of America, it is estimated that there are up to approximately500,000 Americans with ulcerative colitis.
About Rheumatoid Arthritis
According to the American College of Rheumatology, more than two millionAmericans suffer from rheumatoid arthritis (RA), a chronic autoimmune diseasethat develops when certain cells of the immune system inappropriately attackhealthy joint tissue, thereby causing swelling, inflammation and damage ofjoints, as well as systemic inflammation and damage of other tissues.
Medarex is a biopharmaceutical company focused on the discovery,development and potential commercialization of fully human antibody-basedtherapeutics to treat life-threatening and debilitating diseases, includingcancer, inflammation, autoimmune disorders and infectious diseases. Medarexapplies its UltiMAb(R) technology and product development and clinicalmanufacturing experience to generate, support and po