December 8, 2009 (FinancialWire) — Immunomedics, Inc. (NASDAQ: IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, announced that low-dose veltuzumab demonstrated promising activity in patients with relapsed immune thrombocytopenic purpura, including durable complete responses.

Results from this multicenter, open-label, Phase I/II study were presented at the 51st annual meeting of the American Society of Hematology .

At the time of reporting, 29 patients had been enrolled into the study, of which 26 had been assessed for treatment response. The overall objective response rate was 69%, with 23% of patients having a complete response. Seven patients who had been diagnosed with the autoimmune disease one year or less had the highest objective and complete response rates of 100% and 60%, respectively. Responses occurred with both the subcutaneous and intravenous administrations, and across all dose levels, including the lowest dose of 80 mg. More importantly, among the 6 complete responders, 5 are still continuing, with 3 patients being in complete response for over 1 year.

Results from the Phase I portion of the study have been reported. (Please refer to the company’s press release at www.immunomedics.com/news_pdf/2009_PDF/PR06052009.pdf for more information).

Immunomedics is collaborating with Nycomed, which received the exclusive, worldwide rights to develop, manufacture and commercialize the subcutaneous formulation of veltuzumab for the treatment of all non-cancer indications.

In a separate presentation, Mayo Clinic clinical investigators reported results from their study evaluating the ability of positron-emission tomography to predict the outcome of patients with diffuse large B-cell lymphoma (DLBCL) treated with the company’s proprietary antibody, epratuzumab, in combination with rituximab and CHOP therapy (ER-CHOP). This study is part of the North Central Cancer Treatment Group’s (NCCTG) Phase II trial carried out to assess the efficacy of ER-CHOP in newly diagnosed DLBCL. Final efficacy results from this study had been reported by the Mayo Clinic, during the ASCO meeting last June. (Please refer to the company’s press release at www.immunomedics.com/news_pdf/2009_PDF/PR05152009.pdf for more information).

The Phase II study enrolled a total of 80 patients to receive 6 cycles of ER-CHOP. Functional response as measured by fluorodeoxyglucose -PET/CT were obtained from 69 and 68 patients after 2 and 6 cycles, respectively, of ER-CHOP therapy. A negative PET scan is considered a complete response .

Patients that achieved a functional CR had improved overall survival and event-free survival at 24 months (EFS24) compared to patients who failed to achieve a functional CR, suggesting achievement of PET negativity by completion of therapy is associated with a good outcome. However, early PET scanning during therapy does not significantly predict outcome. After 2 cycles of ER-CHOP therapy, EFS24 was 73% for the PET-negative patients vs 60% for the PET-positive patients; OS24 was 83% vs 73% for the PET-negative and -positive patients, respectively. In comparison, after 6 cycles of treatment, EFS24 for patients with a negative PET was 80% vs 57% for those with a positive PET and OS24 was 92% vs 57%, respectively.

The NCCTG is currently working with the Eastern Cooperative Oncology Group on the design of a Phase II/III clinical trial comparing ER-CHOP vs R-CHOP in patients with previously untreated DLBCL.

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