Immunomedics Reports Results for Epratuzumab in Sjogren's Syndrome

June 10, 2005

Immunomedics has reported encouraging results from its Phase I/II trial with its compound, epratuzumab, for the treatment of Sjogren's syndrome, an autoimmune disease that currently affects between 2 to 4 million Americans.

Evidence suggests that B-cells may play a key role in the inflammatory cascade of Sjogren's syndrome or lupus. Consistent with the company's past clinical experience with epratuzumab, the investigators also found a reduction of 50 percent to 60 percent in circulating B-cells in the patients enrolled in the trial. This data suggests that B-cell modulation may be the primary mechanism of action of epratuzumab, and that complete depletion of B-cells is not necessary to provide a clinical benefit.

Fifteen patients with primary Sjogren's syndrome were enrolled in this open-label, nonrandomized, two-center study to assess feasibility, safety, and early evidence of efficacy. Over an eight-week period, patients received 360 mg/m2 of epratuzumab every two weeks for a total of four doses. Fourteen patients received all four infusions without reactions with a median infusion time of 50 minutes. One patient discontinued the third infusion due to an acute infusion reaction, but completed the fourth infusion with no further reaction.

Patients reported improvements in their clinical signs and symptoms. Specifically, 24 hours after the last treatment, symptomatic improvements ranging from 100 percent of patients experiencing tender joints to 33 percent of patients with salivary flow were observed. Moreover, when these patients were evaluated 12 weeks post-therapy, 86 percent of patients who showed tender joints improvement retained clinical benefit, as did 20 percent of patients with increased salivary flow. A final evaluation is planned for six months after the last epratuzumab dose.