Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the
Company has reached agreement with the U.S. Food and Drug
Administration (FDA) under its Special Protocol Assessment (SPA)
process for the design of the Company’s Phase 3 clinical trial of
FOLOTYN® (pralatrexate injection) in patients with previously
undiagnosed peripheral T-cell lymphoma (PTCL). The study will seek
to enroll newly diagnosed patients with PTCL who have achieved a
response following initial treatment with a CHOP-based therapy. 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.
“We are pleased to have reached agreement with the FDA on the
design of this pivotal Phase 3 trial of FOLOTYN as part of the
first line treatment of patients with PTCL,” said Charles Morris,
MB ChB, MRCP, chief medical officer at Allos Therapeutics. “This
important study has the potential to support the conversion of our
current accelerated approval in the U.S. to a full approval and
expand FOLOTYN’s indication to the first-line setting. The study
further demonstrates our commitment to the medical community and
patients to explore the full potential of FOLOTYN and improve
outcomes for patients with PTCL.”
This Phase 3, randomized, multi-center, international clinical
trial will seek to establish the safety and efficacy of sequential
FOLOTYN versus observation in patients with previously undiagnosed
PTCL who have achieved a response following initial treatment with
CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
or CHOP-based chemotherapy. The co-primary endpoints will be
progression-free survival and overall survival. The Company expects
to initiate this Phase 3 clinical trial of FOLOTYN in 2011.
In September 2009, FDA granted accelerated approval of FOLOTYN
for use as a single agent for the treatment of patients with
relapsed or refractory PTCL. This approval was based on overall
response rate from the Company’s pivotal Phase 2 trial known as
PROPEL. Clinical benefit such as improvement in progression-free
survival or overall survival has not been demonstrated. FOLOTYN is
the first and only drug approved by the FDA for this indication.
FDA’s accelerated approval program allows the FDA to approve
products for cancer or other life-threatening diseases based on
initial positive clinical data. In connection with the accelerated
approval, the Company is required to conduct post-approval studies
that are intended to verify and describe FOLOTYN’s clinical benefit
in patients with T-cell lymphoma. An updated analysis of data from
PROPEL was recently published in the Journal of Clinical
Oncology.
About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a biologically diverse group of blood
cancers that account for approximately 10% to 15% of all cases of
non-Hodgkin lymphomas (NHL).1-3 The Company 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 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 September 2009, the U.S. Food and Drug
Administration (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.
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 FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma.
Allos is also developing FOLOTYN in other hematologic malignancies
and solid tumors. Allos retains exclusive worldwide rights to
FOLOTYN for all indications. Allos is headquartered in Westminster,
CO. 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 Company’s intent and
projected timeline to initiate a Phase 3 trial of FOLOTYN in
patients with previously undiagnosed PTCL; the potential for this
Phase 3 trial to support the conversion of the Company’s
accelerated approval in the U.S. to a full approval and expand
FOLOTYN’s indication to the first-line setting; 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. Important factors that may cause actual
results to differ materially include, but are not limited to, that
the Company may experience delays in the initiation and/or
completion of its clinical trials, including the planned Phase 3
trial of FOLOTYN in patients with previously undiagnosed PTCL,
whether caused by competition, adverse events, patient enrollment
rates, regulatory issues or other factors; that the Phase 3 trial
may not demonstrate that FOLOTYN is both safe and more effective
than current standards of care; that data from prior preclinical
studies and clinical trials of FOLOTYN may not necessarily be
indicative of future clinical trial results; that the safety and/or
efficacy results of the Phase 3 trial will not support an
application for marketing approval in the United States or any
other country; that the FDA may initiate proceedings to withdraw
the Company’s current accelerated approval for FOLOTYN if the Phase
3 study fails to verify the clinical benefit of FOLOTYN; and the
risk that the Company may lack the financial resources and access
to capital to fund the planned Phase 3 trial or any additional
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 Form
10-K for the year ended December 31, 2010, 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 registered 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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