By Kim Coghill
Immunomedics Inc. said Tuesday it started a pivotal Phase III pivotal trial to study LymphoCide (epratuzumab) for the treatment of patients with non-Hodgkin's lymphoma.
The drug targets patients who have failed or are refractory to other forms of therapy, including a prior therapy with an antibody against the CD20 marker of NHL. Company officials could not be reached for comment.
The first pivotal trial focuses on a subset of patients with low-grade or indolent NHL.
"We have worked with the FDA to design this trial, which we anticipate will enroll patients at more than 30 clinical sites in the U.S., Canada, and Europe," Cynthia Sullivan, executive vice president and chief operating officer of Morris Plains, N.J.-based Immunomedics, said in a news release. "The clinical sites are ready to start and we anticipate patients beginning enrollment shortly."
Before the end of the year, the company also plans to request regulatory approval for a second Phase III pivotal trial in patients with the aggressive form of NHL.
In Phase I/II, the company said it has seen complete remissions in patients with aggressive NHL who had failed prior chemotherapy, antibody therapy and stem cell transplants.
Separately, the first patients have been entered into a Phase II clinical study evaluating the therapy of both the indolent and aggressive forms of NHL by a combination of two different unlabeled antibodies: LymphoCide and Rituxan (rituximab), an Idec Pharmaceuticals Inc. and Genentech Inc. drug. n