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Promising Results with Epratuzumab and Chemotherapy in Children,with Acute Lymphoblastic Leukemia

- Results from a Children's Oncology Group (COG) Study Presented at American Society of Clinical Oncology Annual Meeting -

CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that treatment with epratuzumab plus standard chemotherapy is feasible and well tolerated in children with B-precursor acute lymphoblastic leukemia (ALL), producing favorable early responses in the majority of patients. Elizabeth Raetz, MD, pediatric oncologist at New York University, New York, in an oral presentation at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, reported results from this multicenter feasibility/phase II study.

Fifteen patients with CD22-positive ALL in marrow relapse were enrolled in the feasibility portion of the study. Nine patients were in first and 3 in second or later marrow relapse. Epratuzumab was given alone at 360 mg/m2 twice weekly for two weeks followed by 4 weekly doses of epratuzumab in combination of standard cytotoxic chemotherapy. Within 24 hours of the 6-week treatment period, surface CD22 antigen was not detected on peripheral blood leukemic blasts in all but one of the 12 assessable patients, indicating effective targeting of leukemic cells by epratuzumab. At the time of reporting, 9/12 patients (75%) achieved a complete remission, of whom 7 showed no residual disease by flow cytometry; 1 patient had a partial response, 1 stable disease, and 1 with disease progression.

"We are encouraged by these results. The phase-2 portion of the study is now opened for enrollment of 112 patients, with a primary endpoint of second complete remission rate," commented Dr. Raetz, the study chair.

"We are pleased that COG shares our enthusiasm for epratuzumab and has chosen to evaluate our antibody in the
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