Rockville-based Emergent BioSolutions Inc. (NYSE:EBS) has started Phase 1b/2 clinical trials study for a new drug that it hopes will aid patients in the treatment of lymphoma.
The treatment labeled TRU-016, will be administered in combination with Rituximab and Bendamustine in patients who have relapsed from indolent B-cellLymphoma.
Emergent will collaborate with Abbott on the study where up to 12 patients in Phase 1b, will be given -- intravenously -- two dose levels of the TRU-016 in combination with Rituximab and Bendamustin -- a grouping that Emergent believes is most effective.
In the Phase 2 segment, about more 76 patients will be tested for the efficacy of TRU-016, together with 375 mg/m2 of Rituximab and 90 mg/m2 of Bendamustine, compare with just Bendamustine and Rituximab.
A total of 88 patients will be in the trials expected to be completed by the end of 2012.
Dr. Scott Stromatt, Vice President of Clinical Research and Chief Medical Officer at Emergent BioSolutions stated, "Although patients show a high rate of clinical response to first line therapies they often relapse and in many cases, develop a resistance to treatment," Stromatt continued "Our preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone. TRU-016 is also synergistic with rituximab in preclinical models. Based on these data, as well as data from our ongoing clinical studies of TRU-016 for chronic lymphocytic leukemia, we believe that TRU-016 in combination with bendamustine and rituximab could produce meaningful results in patients with indolent NHL."
The National Cancer Institute says there are approximately 65,980 new cases of non-Hodgkin's Lymphoma (NHL) diagnosed annually. NHL is a cancer that attacks the body's lymph system, an area made up of immune system blood cells. B-cells are the most common and help the body fight against bacteria and viruses.