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.”
About COMPLETE
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 Hôpital 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.
References:
1. 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. 2. Hennessy BT, Hanrahan EO, Daly PA.
Non-Hodgkin lymphoma: an update [review]. Lancet Oncol.
2004;5(6):341-353. 3. O'Leary HM, Savage KJ. Novel therapies in
peripheral T-cell lymphomas [review]. Curr Oncol Rep.
2008;134(5):202-207. 4. 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. 5. Savage KJ. Peripheral T-cell Lymphomas.
Blood Rev. 2007; 21:201-216.
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