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Phase II Trial of Elsamitrucin in Refractory Non-Hodgkin's Lymphoma Launched
The multi-center phase 2 trial is designed to evaluate the objective response rate, time to disease progression and safety of elsamitrucin, as well as to better define the appropriate patient population, including NHL subtypes that are most responsive to elsamitrucin, for pivotal trials. The trial will enroll approximately 80 patients who have failed multiple prior therapies, including Rituxan (R), a targeted therapy indicated for certain types of NHL. Patients will receive weekly injections of elsamitrucin until disease progression.
"During our recent conference call highlighting our financial results for 2003 and goals for 2004 and beyond, we said that we would advance our portfolio of product candidates, including the initiation of phase 2 trials of elsamitrucin in the second quarter of 2004. Today, I am pleased to say that we have taken the first of several steps to achieve our goal of finishing 2004 with a more advanced and broader portfolio of product candidates," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals.
The design of the current Phase 2 trial builds on a previous phase 2 trial conducted by Bristol Myers Squibb (BMS). The trial had enrolled 31 patients with refractory NHL, of whom approximately 60% had failed at least two prior treatment regimens. The data demonstrated initial evidence of anti-tumor activity for elsamitrucin as a single agent, with a 25% objective response rate in this difficult-to-treat patient population, as well as a favorable side effect profile, notably, minimal toxicity to bone marrow.
Elsamitrucin is an anti-tumor antibiotic that acts as a dual inhibitor of two key enzymes involved in DNA replication, topoisomerase I and II. By inhibiting the activity of these two enzymes, elsamitrucin is thought to lead to DNA breaks that prevent the correct replication of DNA and ultimately result in cancer cell death.
Non-Hodgkin's lymphoma is a tumor arising from the lymph nodes. According to the American Cancer Society, an estimated 54,370 new cases and 20,730 deaths will occur from non-Hodgkin's lymphoma in 2004 in the U.S. In early stages, localized diseased lymph nodes can be treated with radiation therapy. Later stages of this disease are treated with chemotherapy or with chemotherapy plus radiation and targeted therapeutic antibodies, including Rituxan (R), depending on the type of non-Hodgkin's lymphoma. For highly refractory patients failing multiple treatment modalities, treatment alternatives are currently limited, with no FDA approved treatments available.
Source: Spectrum Pharmaceuticals, Inc.