Spectrum initiates ZEVALIN and MGd Phase 2 combination study in NHL

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the initiation of a Phase 2 study evaluating ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). MGd is a redox modulating agent designed to selectively accumulate in cancer cells and interact with intracellular reducing metabolites, producing reactive oxygen species that can disrupt cell function and cause apoptosis (cell death). Results of a previous Phase 1/2 pilot study demonstrated that the combination of ZEVALIN regimen with MGd was well-tolerated and resulted in an overall response rate (ORR) of 86%, a complete response (CR) rate of 64% and the median time to treatment failure of 14-months in the rituximab-refractory follicular lymphoma patients group>et al., Clinical Cancer Research, 2009).

"The commencement of the Phase 2 trial advances our strategy to explore new ways of using the ZEVALIN regimen in its current indication while we continue to study additional therapeutic applications to broaden the potential number of patients who can be helped by ZEVALIN, such as our Phase 3 program for the treatment of diffuse large B-Cell lymphoma," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "MGd is a particularly promising agent for use in combination with radioimmunotherapy, having shown a synergistic treatment effect in earlier research with radiation therapy and chemotherapeutic agents. The safety database for MGd includes results from more than 1000 patients. We look forward to the progress of our recently initiated study, which is designed to confirm and extend these initial promising findings."

The multicenter, randomized, open-label, Phase 2 study is designed to evaluate the safety and efficacy of the novel combination therapy. The trial is designed to enroll a total of 100 patients in North America, who will be randomized to one of two treatment arms: ZEVALIN + rituximab, and MGd, or ZEVALIN + rituximab. The treatment period will be 10-12 days, followed by 12-week safety follow up and then up to 12-month follow up. The primary endpoint is the complete response (CR) rate within 6 months of study entry, while secondary endpoints consist of CR rate within 3 months, overall response rate within 6 months, and progression-free survival.