Allos Therapeutics, Inc. (NASDAQ: ALTH) today
announced that five abstracts, describing FOLOTYN® (pralatrexate
injection) data across different types of blood cancers, were
accepted in the program for this year’s 52nd American Society of
Hematology (ASH) Annual Meeting to be held December 4-7, 2010, in
Orlando, Florida.
“At ASH, new and updated analyses expand our
understanding of the clinical data for FOLOTYN in patients with
T-cell lymphoma, including data from the pivotal Phase 2 PROPEL
study in relapsed or refractory peripheral T-cell lymphoma and
transformed mycosis fungoides, as well as updated results from the
Phase 1 dose-finding study in relapsed or refractory cutaneous
T-cell lymphoma,” said Charles Morris, MB ChB, MRCP, chief medical
officer at Allos Therapeutics. “Allos is committed to exploring the
potential of FOLOTYN to address the treatment needs for patients
with devastating diseases, such as T-cell lymphoma. We are pleased
that the American Society of Hematology has chosen these important
findings to be included in this year’s meeting and look forward to
sharing the full results with the hematology community in
December.”
FOLOTYN, a folate analogue metabolic inhibitor,
is the first and only drug approved in the U.S. for the treatment
of patients with relapsed or refractory peripheral T-cell lymphoma
(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 abstract details are as follows:
Abstract Title: “Pralatrexate
is an Effective Treatment for Heavily Pretreated Patients with
Relapsed or Refractory Transformed Mycosis Fungoides (tMF)”First
Author: Francine Foss, MD, Yale Medical
CenterAbstract Number: 1762 (Poster Board
I-742)Location: Hall A3/A4 – Orange County Convention
CenterPresentation Date/Time: Saturday, December 4,
5:30-7:30 p.m.
Abstract Title: “Pralatrexate
is Effective as Second-line Treatment Following
Cyclophosphamide/Doxorubicin/ Vincristine/Prednisone (CHOP) Failure
in Patients with Relapsed or Refractory Peripheral T-cell
Lymphoma”First Author: Andrei Shustov, MD, Seattle Cancer
Care AllianceAbstract Number/Location: Publication Only
Abstract Title: “Pralatrexate
is Effective in Patients with Relapsed or Refractory Peripheral
T-cell Lymphoma with Prior Ifosfamide, Carboplatin, and Etoposide
(ICE)-based Regimens”First Author: Andrew Goy, MD, John
Theurer Cancer Center at Hackensack University Medical
CenterAbstract Number: 1753 (Poster Board
I-733)Location: Hall A3/A4 – Orange County Convention
CenterPresentation Date/Time: Saturday, December 4,
5:30-7:30 p.m.
Abstract Title: “Pralatrexate
Reverses the Trend to Progressive Resistance to Successive Systemic
Treatment Regimens in Patients with Relapsed or Refractory
Peripheral T-cell Lymphoma”First Author: Owen O’Connor, MD,
New York University Medical CenterAbstract Number/Location:
Publication Only
Abstract Title:
“Identification of an Active, Well-Tolerated Dose of Pralatrexate
in Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma
(CTCL): Results of a Multicenter Dose-Finding Study”First
Author: Steven Horwitz, MD, Memorial Sloan-Kettering Cancer
CenterAbstract Number: 2800 (Poster Board
II-680)Location: Hall A3/A4 – Orange County Convention
CenterPresentation Date/Time: Sunday, December 5, 6:00-8:00
p.m.
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 lymphoma (NHL) in the United
States.1-3The American Cancer Society estimated that approximately
66,000 new cases of NHL were expected to be diagnosed in the U.S.
in 2010. The Company estimates the current annual incidence of PTCL
in the U.S. to be approximately 5,900 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
PTCL is a diverse group of aggressive, mature T
and NK (natural killer) cell non-Hodgkin lymphomas which include
PTCL-NOS (PTCL not otherwise specified), AITL (angioimmunoblastic
T-cell lymphoma), and ALCL (anaplastic large-cell lymphoma).1
Transformed mycosis fungoides (tMF) is an aggressive disease which
is generally associated with poor prognosis for patients.6 Based on
the aggressive nature of tMF, these patients were also eligible for
the PROPEL study.
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma, or CTCL, is
comprised of indolent non-Hodgkin T-cell lymphomas which have their
primary manifestations in the skin. The most common CTCL subtypes
are mycosis fungoides and Sézary syndrome. According to the
Lymphoma Research Foundation, CTCL accounts for approximately 2% to
3% of the estimated 66,000 new cases of non-Hodgkin's lymphoma
diagnosed each year in the United States. The estimated annual
prevalence of CTCL in the United States is 16,000 and 20,000 cases
in the U.S.7
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.
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.
Dermatologic reactions may occur. Patients with
dermatologic reactions should be monitored closely, and if skin
reactions are severe, FOLOTYN should be withheld or
discontinued.
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 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 data from preclinical studies and clinical
trials may not necessarily be indicative of future clinical trial
results; that the safety and/or efficacy profile for FOLOTYN may
not support further clinical development in patients with 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
September 30, 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
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. 6.
Vergier, Beatrice. Transformation of
mycosis fungoides: clinicopathological and prognostic features of
45 cases.
Blood Volume. 2000: 95: 2212-2218.
7.
Cutaneous Lymphoma Foundation. CTCL-MF
fast facts. Retrieved May 21, 2010, from
http://clfoundation.org/publications/CL_fast_facts.pdf.
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