SEATTLE, Dec. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that the results of three Italian multicenter studies utilizing Zevalin(R) ([90Y]-ibritumomab tiuxetan) were presented at the American Society of Hematology (ASH) 50th Annual Meeting in San Francisco, CA.
In one presentation, the Italian Cooperative Study Group in a phase II study investigated the use of single dose Zevalin as sole initial treatment in 15 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% in continuous CR. No patients required hematopoietic growth factors. Hematologic toxicity was low and quickly reversible; 7 patients developed grade 3 thrombocytopenia and 5 required platelet transfusions.
In a second presentation, investigators from the European Institute of Oncology, Milan treated 13 patients with relapsed or refractory primary gastric NHL including 9 patients with Mucosa Associated Lymphoid Tissue or MALT with a single dose of Zevalin. Ten of 13 patients achieved a CR with all 9 patients (100%) with MALT achieving a CR. Toxicities were mainly hematologic and reversible. After a median follow up of 36 months 9 of 10 CR's (90%) are disease free.
The potential benefits of RIT with Zevalin combined with BEAM conditioning regimen (Z-BEAM) followed by autologous stem cell transplantation (ASCT) for patients who fail to achieve a CR after front line rituximab containing multi- agent chemotherapy for advanced NHL was also presented. The results of the Italian Multicenter Study demonstrated that among 53 patients who failed to achieve CR after CHOP-R, the Z-BEAM followed by ASCT resulted in a 74% CR rate. At a median follow up of 175 days post transplant 40 patients (75%) are alive, 30 patients (57%) in CR. Fourteen patients died, 7 due to treatment related toxicities, and 6 due to progressive disease. The estimated 3 year event free survival (EFS) 64%.
"These three additional studies add to the growing body of clinical trial evidence that radio-immunotherapy with Zevalin produces high, durable rates of complete remission in high risk, relapsed or refractory NHL," noted Jack Singer, M.D. and Chief Medical Officer of CTI. "We believe that the impressive 73% CR rate when given as a single agent in previously untreated patients with follicular NHL is worth pursuing in additional trials as it could potentially provide an alternative to multiagent chemotherapy regimens particularly among elderly or infirm patients. Similarly, the 100% CR rate in MALT is an intriguing finding that could represent an additional registration route as it is an unmet medical need. We believe with these and additional prospective randomized clinical trials Zevalin, Radio-Immunotherapy, may finally assume a role alongside cornerstone treatment regimens for NHL," Dr. Singer added.
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) 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 Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
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.celltherapeutics.com.
This press release includes forward-looking statements about trials conducted by third parties and future potential trials that may conducted by CTI 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 future 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 for Zevalin to be proved safe and effective for the treatment of additional indications as noted in these presentations or any other indication, the success of the proposed joint venture for Zevalin with Spectrum Pharmaceuticals, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, the costs of developing, producing and selling Zevalin and CTI's ability to raise additional capital to fund additional clinical trials for Zevalin. You should also review 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 law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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