Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that
data on FOLOTYN® (pralatrexate injection) will be presented at two
upcoming medical conferences: the 46th Annual Meeting of the
American Society of Clinical Oncology (ASCO), which will be held
June 4-8 in Chicago, Illinois, and at the 15th Congress of the
European Hematology Association (EHA), which will be held June
10-13 in Barcelona, Spain.
"At ASCO and EHA, further analyses of the final efficacy data
from our PROPEL pivotal trial of FOLOTYN expand our understanding
of the clinical benefit for patients with relapsed or refractory
peripheral T-cell lymphoma,” said Charles Morris, MB ChB, MRCP,
chief medical officer at Allos Therapeutics. “In addition, at EHA,
updated interim data from our Phase 1 trial of FOLOTYN in cutaneous
T-cell lymphoma, a disease that is related to PTCL but follows a
more indolent clinical course, show that FOLOTYN is active in this
population. In addition we have an ASCO abstract describing an
ongoing Phase 2 trial in B-cell lymphoma, part of our commitment to
further exploring FOLOTYN’s utility in a broad range of
cancers.”
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). Allos is
also developing FOLOTYN in other potential indications.
Information regarding the ASCO presentations and abstracts is
below. Full abstracts can be viewed on the ASCO website at
www.asco.org and will be published in ASCO Annual Meeting
Proceedings Part I.
Presentation Date/Time: Saturday, June 5, 8:00 a.m. –
12:00 p.m. (CDT)Poster Title: “Pralatrexate in Patients with
Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL): Relationship
Between Response and Survival”First Author: Andrei R.
Shustov, M.D., Seattle Cancer Care AllianceAbstract Number:
8054Location: S Hall A2 of the McCormick Convention Center,
Chicago, Illinois
Abstract Title: “A Phase 2, Single-Arm, Open-Label Study
of Pralatrexate in Patients with Aggressive Relapsed or Refractory
B-cell Non-Hodgkin's Lymphoma (NHL): Study PDX-015”First
Author: Julie E. Chang, M.D., University of Wisconsin Hospital
and ClinicsAbstract Number: e18568Location:
Publication only
Information regarding the EHA presentations is below. Full
abstracts can be viewed on the EHA website at
http://eha.eurocongres.com.
Presentation Date/Time: Friday, June 11, 5:45 – 7:00
p.m.Poster Title: “Pralatrexate Activity in Patients with
Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL): Relationship
Between Response at Cycle 1 and Subsequent Survival”First
Author: Bertrand Coiffier, M.D., Ph.D., Hospices Civils de Lyon
Pierre-Benite, FranceAbstract Number: 1981Location:
Hall 6 of the Gran Via Conference Center, Barcelona, Spain
Presentation Date/Time: Friday, June 11, 5:45 – 7:00
p.m.Poster Title: “Pralatrexate Efficacy and Tolerability in
Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
(CTCL)”First Author: Steven Horwitz, M.D., Memorial
Sloan-Kettering Cancer CenterAbstract Number:
2117Location: Hall 6 of the Gran Via Conference Center,
Barcelona, Spain
About Peripheral T-cell Lymphoma (PTCL)
T-cell lymphomas comprise a biologically diverse group of blood
cancers that account for approximately 10% to 15% of all cases of
non-Hodgkin’s lymphoma (NHL) in the United States.1-3 The American
Cancer Society estimated that approximately 66,000 new cases of NHL
were expected to be diagnosed in the U.S. in 2009. 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
About Non-Hodgkin's Lymphoma (NHL) and Hodgkin's
Lymphoma
According to the American Cancer Society, an estimated 66,000
new cases of NHL were expected to be diagnosed in the United States
in 2009, an estimated growth in incidence of approximately 4%
annually from 2005 through 2009. Approximately 85% of NHL patients
represent patients with B-cell lymphoma. Patients with indolent or
low-grade NHL may have survival rates as long as 10 years, yet the
disease is frequently incurable. Aggressive lymphomas generally
result in shorter median survival times although patients with
these malignancies can be cured in 30 to 60% of cases.
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number
of indolent non-Hodgkin's T-cell lymphomas, including mycosis
fungoides and Sézary syndrome, which have their primary
manifestations in the skin. 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. According to the Cutaneous Lymphoma
Foundation, the estimated annual prevalence of CTCL in the United
States is between 16,000 and 20,000 cases.6
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 potential indications.
Allos retains exclusive worldwide rights to FOLOTYN for all
indications. Allos is headquartered in Westminster, Colo. For
additional information, please visit www.allos.com.
Important Safety InformationWarnings 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.
Adverse Reactions:
The most common adverse reactions observed were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events were 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/sulfamethaxazole) may result
in delayed renal clearance.
For additional important safety information, please see the full
prescribing information for FOLOTYN at www.allos.com.
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.
6. Cutaneous Lymphoma Foundation. CTCL-MF fast facts
http://clfoundation.org/publications/CL_fast_facts.pdf. Accessed
May 21, 2010.
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