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.
Innovative urine test could improve pancreatic cancer survival rates