WESTMINSTER, Colo.--(BUSINESS WIRE)--Nov. 11, 2009-- 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 Agency
Abstract 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 Angeles
Abstract 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 Center
Abstract Number: 1681 (Poster Board I-703)
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: “Pralatrexate and Gemcitabine in Patients with Relapsed or Refractory Lymphoproliferative Malignancies: Phase 1 Results”
First Author: Steven M. Horwitz, MD, Memorial Sloan-Kettering Cancer Center
Abstract Number: 1674 (Poster Board I-696)
Location: Hall E of the Ernest N. Morial Convention Center
Presentation 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 Hope
Abstract 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 Center
Abstract Number: 919
Location: 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.

Source: Allos Therapeutics, Inc.

Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com