Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced that an abstract from the ongoing Phase 2 trial evaluating elsamitrucin as a single agent for the treatment of relapsed or refractory non-Hodgkin's lymphoma (NHL, cancer of the lymphatic system) has been submitted for presentation at the upcoming American Society of Hematology (ASH) 46th Annual Meeting. The meeting will take place in San Diego, California from December 4-7, 2004. The abstract entitled "A multi-center, open-label, non-randomized Phase II study of elsamitrucin (SPI-28090) in patients with relapsed or refractory non-Hodgkin's lymphoma" will be presented by Dr. Ann Mohrbacher from USC/Norris Cancer Hospital in Los Angeles, California.
The preliminary data from patients with advanced (Stage III or IV) NHL, all of whom had failed at least 2 (and as many as 9) prior treatment regimens were consistent with results from a previous Phase 2 trial. Elsamitrucin continues to demonstrate an early evidence of anti-tumor activity against NHL in a difficult-to-treat patient population. In addition, elsamitrucin was well tolerated in the vast majority of patients, with a favorable side effect profile, notably, absent or mild toxicity to bone marrow and non-hematological toxicities limited to mild-to-moderate nausea and vomiting.

Spectrum Pharmaceuticals continues to expect timely completion of enrollment in the ongoing Phase 2 trial, initiated in April 2004, before the end of 2005. 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 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. The design of the current Phase 2 trial builds on a previous phase 2 trial conducted by Bristol Myers Squibb. The trial had enrolled 31 patients with refractory NHL, of whom approximately 60% had failed at least two prior treatment regimens.

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®, 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.