-- “COMPLETE” Registry Designed to Enrich Treatment Practice by
Providing Insight into Global Treatment Trends and Outcomes --
-- Developed in Collaboration with Expert International Steering
Committee --
WESTMINSTER, Colo.--(BUSINESS WIRE)--Dec. 3, 2009--
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.
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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.
Source: Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
