Healthcare Industry News:  Yttrium-90 

Biopharmaceuticals Oncology

 News Release - January 17, 2008

Zevalin(R) Combined With High-Dose Chemotherapy and Autologous Stem-Cell Transplantation (ASCT) Produces High Overall Survival and Progression-Free Survival Rates in Patients With Relapsed Non-Hodgkin's Lymphoma

Results underscore promise of radioimmunotherapy in ASCT and warrant randomized trial

SEATTLE, Jan. 17 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today that results of a phase II clinical study, published in the Journal of Clinical Oncology demonstrate that the addition of radioimmunotherapy (RIT) to high-dose chemotherapy (HDC) followed by autologous stem-cell transplantation (ASCT) produced a high rate (70 percent) of progression-free survival at two years without a significant increase in the toxicity of the HDC regimen underscoring the potential role for RIT in ASCT. Total-body irradiation (TBI) has previously been shown to significantly increase progression-free survival when added to HDC followed by ASCT as compared to HDC alone. However, TBI has long term complications and not all patients are eligible to receive TBI as part of their preparative regimen. Radioimmunotherapy with ZevalinŽ (Ibritumomab Tiuxetan), approved for follicular, low grade NHL which relapsed following 1st line rituximab based therapy, allows high doses of lymphoma-targeted radiation with lower doses to normal tissues.

The study, conducted at the City of Hope Comprehensive Cancer Center, used a single dose of Zevalin in patients undergoing ASCT following HDC with the BEAM regimen (carmustine, cytarabine, etoposide, and melphalan). Thirty-seven of the 41 patients had failed prior rituximab therapy. Seven of the ten patients transplanted in partial remission (70 percent) converted to complete remissions following the Zevalin-based regimen. The addition of Zevalin to the BEAM regimen did not appear to add to the toxicity of HDC; the day 100 mortality rate was zero (0) percent. Importantly the 2-year overall and progression-free survival estimates were approximately 89 percent and 70 percent, respectively.

"The promise of utilizing targeted radioimmunotherapy together with high-dose chemotherapy prior to autologous stem-cell transplant is an exciting new potential application of Zevalin. We expect to explore this as an additional registration direction for Zevalin," noted Jack W. Singer, M.D. Chief Medical Officer at CTI.

The study is reported in the current issue of Journal of Clinical Oncology at http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2007.11.9248.

Study Details

The trial evaluated the safety and efficacy of combining a standard dose of ZEVALIN (14.8 MBq/kg [0.4mCi/kg]) followed by high-dose BEAM and ASCT in patients with non-Hodgkin's lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy. Primary endpoints of the study were overall (OS) and progression-free survival (PFS). Secondary endpoints included safety and long-term complications. Sixty patients were enrolled with 41 patients receiving full protocol of imaging and therapy. Median age of the patients treated was 59.6 years (range 19.8 to 78.9 years). Lymphoma histologies included diffuse B cell (n=20), mantle cell (n=13), follicular (n=4) and transformed (n=4). Median tumor bulk prior to treatment was 3.1cm; median number of prior therapies was 2 with range 1-6. Thirty-five of the 41 patients were alive at the time of analysis; 27 were in remission. With a median follow-up of 18.4 months (range 5.5 to 53.3 months), the Kaplan-Meier estimated 2-year OS and PFS were 88.9 percent and 69.8 percent, respectively. The primary toxicities observed included grade 3 or 4 mucositis in 21 patients, grade 3 hypoxia in eight patients, and grade 3 pneumonitis, which responded to corticosteroids, in 3 patients. Transplantation-related mortality at 100 days was 0 percent. The authors concluded: "Combining 90Y ibritumomab tiuxetan with high dose BEAM before ASCT is feasible with no evidence of increase toxicity. The high rates of PFS, especially in patients with DBCL are also encouraging".

About ZEVALINŽ

ZEVALINŽ (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com for more information.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of ZEVALIN include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with ZEVALIN in particular including, without limitation, the potential failure of ZEVALIN to prove safe and effective in combination with high-dose chemotherapy (BEAM) and autologous stem-cell transplantation for treatment of non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling ZEVALIN, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.


Source: Cell Therapeutics

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