June 17, 2009 (FinancialWire) — Immunomedics, Inc. (NASDAQ: IMMU) said that epratuzumab labeled with the potent radioisotope yttrium-90, when given in small fractionated doses to patients with non-Hodgkin’s lymphoma, achieved high rates of durable responses. Results from this multicenter, open label study were presented at the Society of Nuclear Medicine 56th annual meeting.

“We believe this study demonstrated that by splitting the radioactive dose over two or three fractions, higher total radiation can be delivered to the tumor without increasing the harmful effects of radiation to the bone marrow, thereby making the therapy more tolerable and potentially more effective,” commented Cynthia L. Sullivan, president and CEO.

The goal of the study is to determine the safety, optimal dosing and preliminary efficacy of Y-90-labeled epratuzumab (yttrium-90 epratuzumab tetraxetan) for NHL. Sixty-four adult patients who had failed one or more therapies, including rituximab, had been enrolled to receive 2 or 3 weekly infusions of Y-90 labeled epratuzumab. The starting Y-90 dose was 5.0 mCi/m(2), 2.5 mCi/m(2) for patients with prior bone marrow involvement, with increments of 2.5 mCi/m(2) or 5.0 mCi/m(2). For 17 patients with prior bone marrow transplant, grade 3 to 4 hematologic toxicity limited dose escalation to a total dose of 10 mCi/m(2). For other patients, the treatment was manageable up to 45 mCi/m(2) (15 mCi/m(2) for 3 weeks) total dose.

The overall objective response rate (partial and complete responses) in 62 evaluable patients was 64%, with 49% of patients having a complete response. Both the objective and complete response rates appear to correlate with cumulative doses. In 16 patients unresponsive to last therapy, 75% responded to Y-90 epratuzumab tetraxetan with 56% complete responses. More importantly, responses were seen across all different types of NHL. For follicular lymphoma patients, treatment at 20 mCi/m(2) for 2 weeks was particularly effective, with all 10 patients responding to the treatment, 9 of which were complete responders. In addition, for all 21 follicular lymphoma patients with complete responses, the estimated median progression-free survival is 17.9 months, including responses continuing up to 5 years.

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