Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the
enrollment of the first patient in a Phase 3 randomized clinical
trial (PDX-017) evaluating FOLOTYN® (pralatrexate injection) in
patients with previously undiagnosed peripheral T-cell lymphoma
(PTCL). This study is open to enroll newly diagnosed patients with
PTCL who have achieved an objective response following initial
treatment with CHOP (cyclophosphamide, doxorubicin, vincristine,
and prednisone) or a CHOP-like regimen. Earlier this year, Allos
reached agreement with the U.S. Food and Drug Administration (FDA)
under its Special Protocol Assessment (SPA) process on the design
of this Phase 3 trial. The SPA provides FDA agreement that the
study design and planned analysis of this Phase 3 trial adequately
address the objectives necessary to support a regulatory
submission. FOLOTYN, a folate analogue metabolic inhibitor, is
approved in the U.S. for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL).
“We are pleased to be initiating this Phase 3 trial, which has
the potential to expand the clinical utility of FOLOTYN into the
first-line treatment setting,” said Charles Morris, MB ChB, MRCP,
chief medical officer at Allos Therapeutics. “CHOP and CHOP-based
treatments are the most commonly used therapeutic regimens for
patients with newly diagnosed PTCL; however, a majority of these
patients progress or relapse following CHOP. This Phase 3 study
will explore the potential for FOLOTYN to improve outcomes for
these patients.”
FOLOTYN was approved for the treatment of patients with relapsed
or refractory PTCL in the United States under the FDA's accelerated
approval program, which allows the FDA to approve products for
cancer or other life-threatening diseases based on initial positive
clinical data. As a condition of approval, Allos is required to
conduct post-approval studies that are intended to verify and
describe the clinical benefit of FOLOTYN in patients with T-cell
lymphomas and assess whether FOLOTYN poses a serious risk of
altered drug levels resulting from organ impairment. The Phase 3
study of FOLOTYN in newly diagnosed patients with PTCL following
initial treatment with CHOP or a CHOP-like regimen is one of the
Company’s post-marketing requirements. If successful, the data are
intended to support an expanded indication for FOLOTYN in the
United States in this patient population and to convert the current
accelerated approval for relapsed and/or refractory PTCL to a full
approval. The data are also intended to support global regulatory
submissions for FOLOTYN for this patient population outside the
United States.
Phase 3 Trial Design
PDX-017 is a randomized, open-label, multi-center, international
Phase 3 study that will seek to enroll 549 patients in more than 30
countries. The study will seek to establish the safety and efficacy
of sequential FOLOTYN versus observation in patients with
previously undiagnosed PTCL who have achieved an objective response
following initial treatment with CHOP or a CHOP-like regimen.
The co-primary endpoints of the trial will be progression-free
survival (PFS) and overall survival (OS). Patients will be
randomized in a 2 to 1 ratio to receive either FOLOTYN or to remain
under observation following their initial treatment with CHOP or a
CHOP-like regimen. The initial dose of FOLOTYN will be 30mg/m2
administered 3 out of every 4 weeks, with dose reductions allowed
for defined toxicity.
For more information regarding this trial, refer to
www.clinicaltrials.gov.
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphomas are 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
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 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 FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In May 2011, the Company entered into a strategic
collaboration agreement with Mundipharma International Corporation
Limited (Mundipharma) to co-develop FOLOTYN globally. Under the
agreement, Allos retains full commercialization rights for FOLOTYN
in the United States and Canada, with Mundipharma having exclusive
rights to commercialize FOLOTYN in all other countries.
In September 2009, the FDA granted accelerated approval for
FOLOTYN for use as a single agent for the treatment of patients
with relapsed or refractory PTCL. This indication is based on
overall response rate. Clinical benefit such as improvement in
progression free survival or overall survival has not been
demonstrated. FOLOTYN has been available to patients in the U.S.
since October 2009. An updated analysis of data from the pivotal
PROPEL trial, which supported the FDA’s accelerated approval, was
published in the March 20, 2011 issue of the Journal of Clinical
Oncology. Allos and Mundipharma are currently pursuing regulatory
approval to market FOLOTYN in the European Union for relapsed or
refractory PTCL and are developing FOLOTYN in other potential
indications. Allos’ MAA was accepted for review by the EMA in
December 2010.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. On July 20, 2011, Allos
announced that it had entered into a definitive merger agreement
with AMAG Pharmaceuticals, Inc. The transaction is subject to
approval by both companies’ stockholders and other customary
closing conditions. Allos is currently focused on the development
and commercialization of FOLOTYN® (pralatrexate injection), a
folate analogue metabolic inhibitor. FOLOTYN is approved in the
U.S. for the treatment of patients with relapsed or refractory
PTCL. Allos is also developing FOLOTYN in other hematologic
malignancies and solid tumors. For additional information, please
visit www.allos.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.
Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or
modify dose. Patients should be instructed to take folic acid and
receive vitamin B12 to potentially reduce treatment-related
hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if
needed.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN and pregnant women should
be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to
patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are ≥Grade 3, omit
or modify dose.
Adverse Reactions
The most common adverse reactions were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.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 pace of subject enrollment in the planned
Phase 3 trial may be slower than expected, that the Phase 3 trial
does not successfully meet safety and efficacy endpoints or that
the data from the trial does not support continued marketing of
FOLOTYN, 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 June 30, 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.
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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