Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that
abstracts from studies of FOLOTYN™ (pralatrexate injection) were
accepted for presentation at the 51st Annual Meeting of the
American Society of Hematology (ASH) to be held at the Ernest N.
Morial Convention Center in New Orleans, La., from December 5-8,
2009.
Four poster presentations will summarize new analyses of data
and updated efficacy results from the Company’s pivotal PROPEL
study, which served as the basis for U.S. Food and Drug
Administration’s accelerated approval of FOLOTYN™ on September 24,
2009, for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL). In addition, there will be a
poster summarizing results of a Phase 1 study of FOLOTYN in
combination with gemcitabine in patients with relapsed or
refractory lymphoproliferative malignancies, and an oral
presentation highlighting results of a multicenter, dose-finding
study of FOLOTYN in patients with cutaneous T-cell lymphoma
(CTCL).
Information regarding the ASH presentations is below and full
abstracts can be viewed on the ASH website at www.hematology.org
and will be published in the Blood Abstract Book.
Presentation Date/Time: Saturday, December 5, 2009,
5:30-7:30 p.m. (Central)Poster Title: “Pralatrexate Induces
Responses in Patients with Highly Refractory Peripheral T-Cell
Lymphoma (PTCL)”First Author: Kerry J. Savage, MD, British
Columbia Cancer AgencyAbstract Number: 1678 (Poster Board
I-700)Location: Hall E of the Ernest N. Morial Convention
Center
Presentation Date/Time: Saturday, December 5, 2009,
5:30-7:30 p.m. (Central)Poster Title: “Safety and Management
of Pralatrexate Treatment in Relapsed or Refractory Peripheral
T-Cell Lymphoma (PTCL)”First Author: Lauren Pinter-Brown,
MD, University of California at Los AngelesAbstract Number:
1675 (Poster Board I-697)Location: Hall E of the Ernest N.
Morial Convention Center
Presentation Date/Time: Saturday, December 5, 2009,
5:30-7:30 p.m. (Central)Poster Title: “Correlation between
Baseline Methylmalonic Acid Status and Mucositis Severity in the
PROPEL Study: Implications for Vitamin Prophylaxis”First
Author: Barbara Pro, MD, University of Texas M.D. Anderson
Cancer CenterAbstract Number: 1681 (Poster Board
I-703)Location: Hall E of the Ernest N. Morial Convention
CenterPresentation Date/Time: Saturday, December 5, 2009,
5:30-7:30 p.m. (Central)
Poster Title: “Pralatrexate and Gemcitabine in Patients
with Relapsed or Refractory Lymphoproliferative Malignancies: Phase
1 Results”First Author: Steven M. Horwitz, MD, Memorial
Sloan-Kettering Cancer CenterAbstract Number: 1674 (Poster
Board I-696)Location: Hall E of the Ernest N. Morial
Convention CenterPresentation Date/Time: Monday, December 7,
2009, 6:00-8:00 p.m. (Central)
Poster Title: “Stem Cell Transplant (SCT) and
Pralatrexate Therapy: Outcome of Patients with Relapsed or
Refractory Peripheral T-Cell Lymphoma Who Received SCT Prior to or
Following Pralatrexate Therapy”First Author: Leslie
Popplewell, MD, City of HopeAbstract Number: 3420 (Poster
Board III-357)Location: Hall E of the Ernest N. Morial
Convention Center
Oral Presentation Date/Time: Tuesday, December 8, 2009,
7:30 a.m. (Central)Title: “Pralatrexate is Active in
Cutaneous T-Cell Lymphoma (CTCL): Results of a Multicenter,
Dose-Finding Trial”First Author: Steven M. Horwitz, MD,
Memorial Sloan-Kettering Cancer CenterAbstract Number:
919Location: 260-262 Ernest N. Morial Convention Center
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 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 (1.0 -1.25 mg
orally on a daily basis) and receive vitamin B12 (1 mg
intramuscularly every 8-10 weeks) 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.
Adverse Reactions:
The most common adverse reactions observed in PROPEL were
mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue
(36%). The most common serious adverse events (>3%), regardless
of causality, were pyrexia, mucositis, sepsis, febrile neutropenia,
dehydration, dyspnea and thrombocytopenia. Forty-four percent of
patients experienced a serious adverse event while on study or
within 30 days after their last dose of FOLOTYN. Twenty-three
percent of patients discontinued treatment due to adverse
reactions.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result
in delayed renal clearance.
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.
For additional important safety information, please see the full
prescribing information for FOLOTYN at www.allos.com.
Safe Harbor Statement
The anticipated presentations will contain forward-looking
statements that involve significant risks and uncertainties.
Additional information concerning these forward-looking statements
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,
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 the presentation. All forward-looking
statements are based on information currently available to the
Company on the date thereof, 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.
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