Allos Therapeutics to Launch Global Registry for Patients with Peripheral T-Cell Lymphoma at the American Society of Hematolo...
December 03 2009 - 7:00AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the
launch of an international registry designed to address the urgent
need to better understand treatment patterns and outcomes for
patients with peripheral T-cell lymphoma (PTCL). The registry,
known as COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), is a global observational study
that will enroll patients with newly-diagnosed PTCL and obtain data
regarding longitudinal treatment patterns and outcomes.
Complementing other registries that focus on PTCL incidence or
prognosis at diagnosis, COMPLETE is expected to provide – for the
first time – important and detailed information on PTCL disease
management across various treatment regimens, including drug
therapy, stem cell transplant and radiation therapy. The registry
will be launched during the 51st Annual Meeting of the American
Society of Hematology (ASH) in New Orleans, LA.
COMPLETE is designed to collect data on a real-time basis from
individual healthcare practitioners over three years of patient
enrollment and two years of follow up. It is anticipated that
approximately 75 sites will participate in the registry,
representing academic, hospital and community practices in both the
U.S. and Europe. Data obtained from the registry will be presented
in scientific meetings and published in peer-reviewed journals.
“Knowledge of PTCL, which is a complicated group of diseases,
comes principally from small, disparate clinical trials,” explained
Francine Foss, M.D., professor, C-Director, Yale Cancer Center,
Lymphoma, Leukemia and Myeloma Program, and chair of the COMPLETE
International Steering Committee. “Detailed registries such as
COMPLETE can be invaluable in providing ‘real-world’ data on
specific populations of patients, enabling treating physicians to
better understand how patients are being treated and the outcomes
of treatment, both in routine clinical practice and in clinical
trials. Ultimately, we believe these findings will provide more
insight into the treatment options for patients with PTCL.”
The array of cancer treatments and supportive care choices, as
well as disease recurrence and treatment outcomes, will be gathered
into a database via a confidential web-based system. COMPLETE is
also designed to evaluate whether the results of clinical studies
are being incorporated effectively into daily practice and compare
treatment practices in community and academic settings.
“Existing T-cell lymphoma registries focus primarily on disease
incidence and patient prognosis or are institution specific,
thereby creating a need for a broader registry, like COMPLETE, to
evaluate treatment patterns on a more comprehensive basis,” said
Paul L. Berns, president and chief executive officer of Allos.
“COMPLETE is unique in that it is the first time a broader registry
for patients with PTCL is designed to characterize treatment
patterns in academic and community practices across the U.S. and in
Europe. Our hope and vision is that COMPLETE will enable
practitioners who treat patients with aggressive PTCL to make more
informed treatment decisions based on a better understanding of
potential treatment options and outcomes.”
“With rare diseases, the medical community often has very little
access to information about treatments and outcomes,” said Peter L.
Saltonstall, president and chief executive officer of the National
Organization for Rare Disorders (NORD). “Databases that provide
such information can give medical providers valuable insight that
may lead to better patient care.”
COMPLETE 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 M.D. Anderson 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 implemented by MedNet Solutions, Inc. of
Minnetonka, Minnesota.
Launch Reception
Allos will host a launch reception for COMPLETE on December 6,
2009, from 8:00 p.m.-10:00 p.m. at the Grand Oaks Mansion, New
Orleans. Healthcare professionals who treat patients with PTCL and
attending the ASH annual meeting are invited to attend. Members of
the media are also welcome.
For More Information
Physicians interested in participating or learning more about
COMPLETE should contact Jen Ohme at johme@mednetstudy.com or visit
https://www.mednetregistry.com/mednet/allos/ (Login ID and
password: COMPLETE).
About Peripheral T-cell Lymphoma (PTCL)
Peripheral T-cell lymphomas (PTCL) are a diverse group of
aggressive T-cell and natural killer (NK)-cell non-Hodgkin’s
lymphomas (NHL) that account for approximately 10% to 15% of all
newly diagnosed cases of NHL in the United States.1-3 The American
Cancer Society estimates that approximately 66,000 new cases of NHL
were diagnosed in the U.S. in 2008. The Company estimates the
current annual incidence of PTCL in the U.S. to be approximately
5,600 patients. 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. Allos is currently focused on
the development and commercialization of a folate analogue
metabolic inhibitor for hematologic malignancies and solid tumor
indications. Allos is headquartered in Westminster, CO. For
additional information, 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. 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. Important
factors that may cause actual results to differ materially are
contained in the "Risk Factors" section of the Company's Quarterly
Report on Form 10-Q for the quarter ended September 30, 2009, 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 is a trademark of Allos Therapeutics,
Inc.
References:
- 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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