COMPLETE Registry Provides First Glance into Treatment Patterns for Patients with Peripheral T-Cell Lymphoma.
LUGANO, Switzerland -- Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the presentation of initial data from COMPLETE, an international registry designed to address the urgent need for an increased understanding of the treatment patterns and outcomes for patients with peripheral T-cell lymphoma (PTCL). The registry, supported by Allos Therapeutics, Inc., is guided by a prestigious multi-disciplinary steering committee. Data were presented in a poster presentation at the 11th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (June 15-18) by Dr. Francine Foss.
PTCL is a biologically diverse group of aggressive, mature T and NK (natural killer) cell non-Hodgkin lymphomas with similar outcomes, which include PTCL-NOS (PTCL not otherwise specified), AITL (angioimmunoblastic T-cell lymphoma), and ALCL (anaplastic large-cell lymphoma).1 The prognosis for patients with PTCL is generally poor for most subtypes.2
"These data from COMPLETE represent a first step toward increasing the understanding of peripheral T-cell lymphoma - where, although progress has been made in the treatment of this disease, there remains a high unmet need to further understand this complicated and rare group of non-Hodgkin lymphomas," explained Francine Foss, M.D., Professor of Medicine, Hematology, at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, and chair of the COMPLETE International Steering Committee. "Registries, such as COMPLETE, can be invaluable in providing 'real-world' data that ultimately increase the community's understanding of how specific patient populations are being treated as well as the outcomes of treatment - both in routine clinical practice and in clinical trials."
COMPLETE - a prospective, longitudinal, multinational, observational study - is collecting data on how patients with PTCL are treated across practice settings and is expected to provide, for the first time, important and detailed information on PTCL disease management across various treatment regimens, including systemic therapy, stem cell transplant, and radiation therapy. The registry is enrolling patients with newly-diagnosed PTCL.
At the time of presentation, 59 sites had been activated and 98 patients enrolled - for which baseline and treatment records have been locked for 74 and 26 patients, respectively. Baseline characteristics presented at ICML show the average patient age to be 58 years with slightly more men enrolled in the registry to date [44 men (59%) and 30 female (41%)]; the most common PTCL subtypes are PTCL-NOS (18 of 74 patients; 24%), ALCL (13 of 74 patients; 18%), AITL (11 of 74 patients; 15%), T/NK cell lymphoma, nasal type (7 of 74 patients; 10 %), and transformed mycosis fungoides (7 of 74 patients; 10%). Treatment records show the most common initial treatment to be induction chemotherapy alone (17 of 26 patients; 65%).
Updated data obtained from the registry will be presented at future scientific meetings and published in peer-reviewed journals.
"With rare diseases, the medical community often has limited access to information about treatment patterns and outcomes. COMPLETE is unique in that it is the first registry designed to characterize treatment patterns across practice settings in the United States and Europe for patients with peripheral T-cell lymphoma," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "As a company focused on increasing overall disease-state awareness and treating patients with relapsed or refractory peripheral T-cell lymphoma, our hope is that COMPLETE will provide important answers for the broader hematology community, as well as inform the development and implementation of future studies."
COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment) is an international registry designed to complement other registries - such as the T-Cell Project - by addressing the urgent need within the hematology community for an increased understanding of the treatment patterns and outcomes for patients with PTCL.
Patients are entered in the registry from time of initial diagnosis and followed for up to 5 years. Data on the array of cancer treatments and supportive care measures, as well as disease recurrence and treatment outcomes, are gathered into a database via a confidential Web-based system on a real-time basis from individual health care practitioners over three years of patient enrollment and two years of follow-up. COMPLETE is designed to evaluate whether the results of clinical studies are being incorporated into daily practice and compare treatment practices among various practice settings. Only locked records (completed and signed off by the investigator) are summarized and reported.
Approximately 75 sites are expected to participate in the registry - representing large and small practices in both the U.S. and Europe. Currently, all open sites are in the Unites States, of which 26 are non-university/community and 33 are academic. Additional sites in Europe are expected to be activated, or enroll, in the near future. Launched in late 2009, the first patient was enrolled in February 2010.
The registry is guided by a prestigious multi-disciplinary steering committee chaired by Dr. Francine Foss and includes: Massimo Federico, M.D. of the University of Modena; Christian Gisselbrecht, M.D. of the Hypital Saint Louis; Eric Hsi, M.D. of the Cleveland Clinic; Steven Horwitz, M.D. of Memorial Sloan-Kettering Cancer Center; Barbara Pro, M.D. of Fox Chase Cancer Center; Lauren Pinter-Brown, M.D. of the University of California, Los Angeles; Emanuele Zucca, M.D. of IOSI/Oncology Institute of Southern Switzerland; and Steven Rosen, M.D. of Northwestern University Medical School.
The program is being supported by Allos Therapeutics, Inc. and administered by MedNet Solutions, Inc. of Minnetonka, Minnesota.
About Peripheral T-Cell Lymphoma
T-cell lymphomas account for approximately 10% to 15% of all cases of non-Hodgkin lymphomas (NHL).1-3 Allos estimates the current annual incidence of PTCL to be approximately 5,900 patients in the U.S. and approximately 6,000-7,000 patients in the top five European markets. The outcome of patients with PTCL is poor and the majority of patients ultimately have refractory disease to a variety of agents, including multi-agent chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP-like regimens. The 5-year overall survival rate in these patients is 25% to 40%, depending on sub-type.4-5
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. For additional information about Allos, please visit www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the potential future development of FOLOTYN for the treatment of patients with peripheral T-cell lymphoma or any other type of cancer; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that the safety and/or efficacy profile for FOLOTYN may not support further clinical development in patients with peripheral T-cell lymphoma or any other type of cancer; and the risk that the Company may lack the financial resources and access to capital to fund future clinical trials for FOLOTYN. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are trademarks of Allos Therapeutics, Inc.
Source: Allos Therapeutics, Inc.
The Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. Blood. 1997;89(11):3909-3908.
Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update [review]. Lancet Oncol. 2004;5(6):341-353.
O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.
Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol 2004;15(10):1467-75.
Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007; 21:201-216.
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|Date:||Jun 16, 2011|
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