Immunomedics has announced that patient dosing has begun in a Phase I/II clinical trial evaluating the safety, tolerability and early indication of efficacy of veltuzumab, its humanized anti-CD20 monoclonal antibody, for the treatment of immune thrombocytopenic purpura.
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The company said that the first patient enrolled in this study responded very favorably to veltuzumab. Prior to receiving a single dose of 80mg of veltuzumab, the patient had a platelet count of less than 30 x 10(9)/L (normal range is above 150 x 10(9)/L). Two days post-therapy, the platelet count increased to 78 x 10(9)/L, and four days post-therapy, the platelet count was considered normal, at greater than 150 x 10(9)/L. Nine days post-therapy, the platelet count was greater than 250 x 10(9)/L.
In this clinical trial, patients with platelet levels greater than 150 x 10(9)/L measured on two separate occasions, at least one week apart, are classified as complete responders. The most recent platelet count remained greater than 150 x 10(9)/L, thus classifying this patient as a complete responder.
Cynthia Sullivan, president and CEO, said: “This initial result is very encouraging, but will need to be substantiated with more patients and monitoring for duration of response.”
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