Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it began a Phase 2 study evaluating ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with redox modulating agent motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
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.
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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.
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 (n=14).
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Spectrum said its pipeline includes phase 3 trial of ZEVALIN as a single dose in diffuse large B-cell lymphoma, and planned phase 3 study of ZEVALIN for chemotherapy-free treatment of previously untreated follicular NHL.
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL. ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
According to the National Cancer Institute, there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and about 18,940 deaths in the United States in 2012.
Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss.
There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
SPPI closed Wednesday's regular session at $12.14. The stock has been trading between $6.94 and $16 for the past 52 weeks.