Cell Therapeutics, Inc. Plans to Submit sBLA for Zevalin Consolidation of First Remission in Advanced Stage Follicular Lymphoma in 2008
SEATTLE, November 27, 2007 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) today announced it intends to utilize the results of the phase III first-line indolent trial of ZEVALIN (Ibritumomab Tiuxetan), known as the FIT trial, for submission to the United States Food and Drug Administration (FDA) for potential approval in the consolidation of first remissions following chemotherapy for patients with follicular non-Hodgkin's lymphoma (NHL). CTI has signed an agreement to acquire the U.S. marketing, sales and development rights to ZEVALIN, however, that acquisition has not yet been completed and remains subject to closing conditions, including obtaining certain third party consents, and until the transaction is closed, ZEVALIN remains a product and trademark of Biogen Idec, Inc. CTI expects the acquisition to close by the end of November and as such is hosting a booth at the ASH meetings. The results of the FIT trial will be presented in an oral session on Monday, December 10 at 3:30 p.m. (Eastern) at the 49th Annual Meeting of the American Society of Hematology (ASH), being held December 8-11, 2007 in Atlanta.
Bayer Schering recently announced it had submitted the FIT results to the EMEA for consideration for a new indication for the product in the European Union (EU). "With our commercial leadership now on board we look forward to the prospects of working closely with Bayer-Schering in providing the support for the Zevalin brand that this important therapeutic deserves," said James A. Bianco, M.D., President and CEO of CTI.
Other presentations at ASH, include a presentation by CTI on pixantrone and 29 presentations by Biogen Idec and Bayer-Schering on ZEVALIN(R). Selected ZEVALIN presentations are included below.
Date Time Poster # Title
(Abstract#)
Saturday,
December 8, 5:30 #236-I The Impact of Incorporating Targeted
2007 PM (1082) Radioimmunotherapy (RIT) into
Transplant Preparative Regimens on
the Incidence of Therapy Related
Myelodysplasia (t-MDS) or AML (t-AML)
Following Autologous Stem Cell
Transplant (ASCT) for Lymphoma.
Sunday, 5:15 Oral Session 90Yttrium Ibritumomab Tiuxetan
Dec. 9, PM (22) (Zevalin) Combined with BEAM (Z -
2007 BEAM) Conditioning Regimen Plus
Autologous Stem Cell Transplantation
in Relapsed or Refractory Follicular
Lymphoma. GELA Phase II Study.
Monday, 12:00 Oral Session Phase II Study of R-CHOP Followed by
December 10, PM (389) 90Y-Ibritumomab Tiuxetan in Untreated
2007 Mantle Cell Lymphoma: Eastern
Cooperative Oncology Group Study
E1499.
Monday, 3:30 Oral Session 90Y-Ibritumomab Tiuxetan (ZEVALIN)
Dec. 10, PM (643) Consolidation of First Remission
2007 in Advanced Stage Follicular
Non-Hodgkins Lymphoma: First Results
of the International Randomized Phase
3 First-Line Indolent Trial (FIT) in
414 Patients.
Monday, 5:00 #631-III Radioimmunotherapy with 90Y-
Dec. 10, PM (3412) Ibritumomab Tiuxetan (Zevalin)
2007 as Consolidation of First Remission
in Patients with Advanced Stage
Follicular Lymphoma: A Real-Time MBR
RQ-PCR Analysis.
Monday, 5:00 #664-III CHOP-R (Cyclophosphamide,
Dec. 10, PM (3445) Doxorubicin, Vincristine, Prednisone,
2007 Rituximab) Compared to CPOP-R
(Cyclophosphamide, Pixantrone,
Vincristine, Prednisone, Rituxamib)
in First-Line Therapy of Diffuse
Large B Cell Lymphoma (DLBCL): An
Interim Analysis.
For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference Web site at www.hematology.org.
About ZEVALIN(R)
ZEVALIN(R) (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 www.zevalin.com for more information.
About Pixantrone
Pixantrone (BBR 2778) is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to currently marketed anthracyclines.
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 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 marketing and development of ZEVALIN or the development of pixantrone, and include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with ZEVALIN and pixantrone in particular including, without limitation, the potential failure of the closing of the acquisition of ZEVALIN, the potential failure of pixantrone as a product candidate to prove safe and effective 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 pixantrone as well as the risk that we may not be able to complete the ZEVALIN acquisition or, if the ZEVALIN acquisition is accomplished, the risk of potential failure of obtaining approval from the FDA for label expansion of 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 is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward- looking statements whether as a result of new information, future events, or otherwise.
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Posted: November 2007
