SEATTLE, Dec. 9 Cell Therapeutics, Inc.(Nasdaq and MTA: CTIC) announced today that the results of three Italianmulticenter studies utilizing Zevalin(R) ([90Y]-ibritumomab tiuxetan) werepresented at the American Society of Hematology (ASH) 50th Annual Meeting inSan Francisco, CA.
In one presentation, the Italian Cooperative Study Group in a phase IIstudy investigated the use of single dose Zevalin as sole initial treatment in15 patients with advanced stage (III-IV) follicular NHL. Ninety-three percent(93%) of patients had a response with 73% achieving a complete remission (CR).At a median follow-up of 10 months, 93% of patients are alive, with 71% incontinuous CR. No patients required hematopoietic growth factors. Hematologictoxicity was low and quickly reversible; 7 patients developed grade 3thrombocytopenia and 5 required platelet transfusions.
In a second presentation, investigators from the European Institute ofOncology, Milan treated 13 patients with relapsed or refractory primarygastric NHL including 9 patients with Mucosa Associated Lymphoid Tissue orMALT with a single dose of Zevalin. Ten of 13 patients achieved a CR with all9 patients (100%) with MALT achieving a CR. Toxicities were mainly hematologicand reversible. After a median follow up of 36 months 9 of 10 CR's (90%) aredisease free.
The potential benefits of RIT with Zevalin combined with BEAM conditioningregimen (Z-BEAM) followed by autologous stem cell transplantation (ASCT) forpatients who fail to achieve a CR after front line rituximab containing multi-agent chemotherapy for advanced NHL was also presented. The results of theItalian Multicenter Study demonstrated that among 53 patients who failed toachieve CR after CHOP-R, the Z-BEAM followed by ASCT resulted in a 74% CRrate. At a median follow up of 175 days post transplant 40 patients (75%) arealive, 30 patients (57%) in CR. Fourteen patients died, 7 due to treatmentrelated toxicities, and 6 due to progressive disease. The estimated 3 yearevent free survival (EFS) 64%.
"These three additional studies add to the growing body of clinical trialevidence that radio-immunotherapy with Zevalin produces high, durable rates ofcomplete remission in high risk, relapsed or refractory NHL," noted JackSinger, M.D. and Chief Medical Officer of CTI. "We believe that the impressive73% CR rate when given as a single agent in previously untreated patients withfollicular NHL is worth pursuing in additional trials as it could potentiallyprovide an alternative to multiagent chemotherapy regimens particularly amongelderly or infirm patients. Similarly, the 100% CR rate in MALT is anintriguing finding that could represent an additional registration route as itis an unmet medical need. We believe with these and additional prospectiverandomized clinical trials Zevalin, Radio-Immunotherapy, may finally assume arole alongside cornerstone treatment regimens for NHL," Dr. Singer added.
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy calledradioimmunotherapy and is indicated as part of the Zevalin therapeutic regimenfor treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicularNHL. Zevalin is also indicated, under accelerated approval, for the treatmentof relapsed or refractory, rituximab-naïve, low-grade and follicular NHL basedon studies using a surrogate endpoint of overall response rate. It wasapproved by the FDA in February of 2002 as the first radioimmunotherapeuticagent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex haveoccurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90Zevalin administration results in severe and prolonged cytopenias in mostpatients. Severe cutaneous and mucocutaneous reactions have been reported. Themost serious adverse reactions of the Zevalin therapeutic regimen wereprimarily hematologic, including neutropenia, thrombocytopenia and anemia.Infusion-related toxicities were associated with pre-administration ofrituximab. The risk of hematologic toxicity correlated with the degree of bonemarrow involvement prior to Zevalin therapy. Myelodysplasia or acutemyelogenous leukemia was observed in 2 percent of patients (8 to 34 monthsafter treatment). Zevalin should only be used by health care professionalsqualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com formore information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation ofwhite blood cells and normally spreads through the lymphatic system, a systemof vessels that drains fluid from the body. NHL can be broadly classified intotwo main forms -- aggressive NHL, a rapidly spreading acute form of thedisease, and indolent NHL, which progresses more slowly. According to theNational Cancer Institute's SEER database there were nearly 400,000 people inthe U.S. with NHL in 2004. The American Cancer Society estimates that in theUnited States 66,120 people are expected to be diagnosed with NHL in 2008.Additionally, approximately 19,160 are expected to die from this disease in2008.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products aimed at making cancermore treatable. For additional information, please visithttp://www.celltherapeutics.com.
This press release includes forward-looking statements about trialsconducted by third parties and future potential trials that may conducted byCTI that involve a number of risks and uncertainties, the outcome of whichcould materially and/or adversely affect actual future results. Specifically,the risks and uncertainties that could affect the future development ofZevalin include risks associated with preclinical and clinical developments inthe biopharmaceutical industry in general and with Zevalin in particularincluding, without limitation, the potential for Zevalin to be proved safe andeffective for the treatment of additional indications as noted in thesepresentations or any other indication, the success of the proposed jointventure for Zevalin with Spectrum Pharmaceuticals, determinations byregulatory, patent and administrative governmental authorities, competitivefactors, technological developments, the costs of developing, producing andselling Zevalin and CTI's ability to raise additional capital to fundadditional clinical trials for Zevalin. You should also review the riskfactors listed or described from time to time in the Company's filings withthe Securities and Exchange Commission including, without limitation, theCompany's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may berequired by law, CTI does not intend to update or alter its forward-lookingstatements whether as a result of new information, future events, orotherwise.Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: email@example.com http://www.CellTherapeutics.com/press_room Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F : 206.272.4434 E: firstname.lastname@example.org http://www.CellTherapeutics.com/investors
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