June 9, 2009 (FinancialWire) — Immunomedics, Inc. (NASDAQ: IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, announced a 68% overall response rate in patients with immune thrombocytopenic purpura treated with low doses of veltuzumab, administered either intravenously or subcutaneously. Results from this multicenter, open-label, single-arm, Phase I/II study were presented at the 14th Congress of the European Hematology Association.

The overall response rate (minor, partial and complete responses) in 19 evaluable patients was 68%, with 26% of patients having a complete response (platelets increased to over 150,000 per microL (150 x 10(9)/L) blood). Responses occurred across all doses tested, including the lowest dose at 80 mg, regardless of the route of administration. More importantly, all patients who have a complete response to veltuzumab continue to maintain their increased platelet levels, with 2 patients continuing for over 1 year. It was found that the responses began within 2-4 days after the first injection of veltuzumab.

“These encouraging results corroborate the initial findings that we reported at the annual meeting of the American Society of Hematology last December,” commented Cynthia L. Sullivan, president and CEO. “The study is now entering into Phase II, where additional patients will be enrolled to receive subcutaneous injections,” she added.

The goal of this first study of veltuzumab in ITP is to evaluate its efficacy at low doses. At the time of reporting, 20 adult chronic ITP patients with platelet counts below 30 x 10(9)/L who failed at least one standard therapy have been treated with 2 veltuzumab doses administered 2 weeks apart. Seven patients received the initial intravenous formulation at 1 of 3 levels: 80, 120 or 200 mg. One patient had an infusion reaction and discontinued treatment. Thirteen patients received subcutaneous injections of veltuzumab at 1 of 3 levels: 80, 160 or 320 mg. The injections were well tolerated with no grade 3-4 adverse events reported.

All patients were evaluated over a 12-week period, with responding patients continuing in long-term follow-up. Patients with platelet levels higher than 150 x 10(9)/L measured on 2 separate occasions, at least 1 week apart, were classified as complete responders. Those with measurements between 50-150 x 10(9)/L were considered partial responders, and minor responses were between 30-50 x 10(9)/L.

Both routes of veltuzumab administration produced B-cell depletion, even at the lowest dose of 80 mg. Two patients had a minor immunogenic response to veltuzumab following intravenous infusions, with no clinical after-effects.

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