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High-Dose Ibritumomab Tiuxetan Provides Significant Clinical Benefit in Patients With High Risk Non-Hodgkin's Lymphoma

SEATTLE, Oct. 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Journal of Clinical Oncology has published the results of an innovative study that investigated high (bone marrow ablative) dose Zevalin® ([90Y]-ibritumomab tiuxetan) followed by autologous stem cell infusions among 30 patients (median age 62 years) with relapsed/refractory or high risk aggressive non-Hodgkin's lymphoma (NHL) not eligible for a chemotherapy-based transplant. High-dose myeloablative chemotherapy is an effective therapy for NHL but because it is associated with significant toxicities it is usually reserved for clinically fit and younger patients and therefore is not an option for many due to the average age of NHL patients being approximately 60 years old. In this study, three cycles of conventional chemotherapy were given followed by high dose chemotherapy with a stem cell rescue and then followed by up to three times the standard dose of Zevalin with an additional stem cell rescue. This treatment regimen resulted in 83 percent of patients achieving a disease free state with a projected overall survival of 87 percent after a median follow up of 30 months.

"Our results suggest that the use of high-dose Zevalin for these patients provides a significant clinical benefit and is very well tolerated," said Alessandro M. Gianni, M.D., Full Professor of Medical Oncology and Director of the School of Specialization in Medical Oncology at the University of Milan. "We are encouraged by the outcome of the study as this regimen could be applicable to the vast majority of high risk or relapsed non-Hodgkin's lymphoma patients."

High-dose Zevalin was well tolerated and no deaths were noted with this regimen. The expected severe marrow suppression associated with myeloablative treatment was seen but patients began to recover neutrophil and platelet counts within 3 weeks. Only minor non-hematologic toxicities were observed. Infections, none greater than grade 3, were noted in 8 patients (27 %) but hospitalization for grade 3 febrile neutropenia was required in only 3 patients. The authors concluded "the mild hematologic toxicity was unprecedented for a myeloablative regimen." The authors go on to state that "A notable and distinct difference in our study from virtually all other regimens of myeloablative polychemotherapy is the nearly complete absence of non- hematologic toxicity. Despite advanced age and presence of co-morbidities in many patients, none experienced vital organ toxicities of any grade. Mucositis, a major cause of toxicity and even infectious mortality after myeloablative treatments, was absent, and all patients were able to maintain normal oral intake of food and water. The excellent tolerability of myeloablative radioimmunotherapy was noteworthy in that 19 patients (63 percent) had previously not met the eligibility criteria for chemotherapy- based autotransplantation regimens as a result of elderly age and/or comorbidities."

"We continue to be impressed with the potential for radioimmunotherapy as an adjunct to, or as in this study, a partial replacement for high-dose chemotherapy in autotransplantation for relapsed-refractory or high risk CD-20 positive B-cell non-Hodgkin's lymphomas," noted Jack Singer, M.D., Chief Medical Officer at Cell Therapeutics. "This investigational regimen adds to the growing body of clinical trial data indicating that Zevalin at higher than FDA approved doses with a stem cell rescue, may provide an added clinical benefit when added to either traditional myeloablative doses of chemotherapy, or as in the present study, added to high-doses of standard chemotherapy."

Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. The Zevalin therapeutic regimen has been given accelerated approval for the treatment of relapsed or refractory, rituximab-naive, low- grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.

Source: Cell Therapeutics, Inc.

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