FOLOTYN Data to be Presented at the Congress of the European Hematology Association and the International Conference on Malignant Lymphoma

WESTMINSTER, Colo.--(BUSINESS WIRE)--Jun 8, 2011 - Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that data on FOLOTYN® (pralatrexate injection) will be presented at two upcoming international medical conferences: the 16th Congress of the European Hematology Association (EHA) in London, England from June 9-12, and the 11th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland from June 15-18.

“Allos is looking forward to the presentation of FOLOTYN data at both EHA and ICML as these analyses provide further support and expand our understanding of FOLOTYN as a single-agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma and as a potential combination therapy in cutaneous T-cell lymphoma,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics, Inc. “In addition, the first presentation of data from COMPLETE – a global peripheral T-cell lymphoma registry expected to provide greater insight into the treatment patterns and outcomes for patients with this type of T-cell lymphoma where there remains a high global unmet treatment need – will also be presented.”

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. In December 2010, Allos announced that the Company's Marketing Authorisation Application (MAA), seeking approval of FOLOTYN for the treatment of patients with relapsed or refractory PTCL, was accepted by the European Medicines Agency (EMA).

Information regarding the key presentation at EHA is as follows:

Abstract Title: “Pralatrexate Selectively Induces Apoptosis and Synergizes with Bexarotene Through Up-Regulation of p53/Bax/PUMA in Cutaneous T-cell Lymphoma Cells”
Abstract Number: 405
Presentation Date/Time: Friday, June 10, 17:45-19:00 CET

Information regarding the presentations at ICML is as follows:

Abstract Title: “Pralatrexate Reverses the Trend in Progressive Resistance with Successive Chemotherapy Regimens in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)”
Abstract Number: 361
Presentation Date/Time: Friday, June 17, 08:30-18:30 CET

Abstract Title: “Pralatrexate, an Effective Single-Agent Second-Line Treatment Following Failure of Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (CHOP) in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)”
Abstract Number: 360
Presentation Date/Time: Friday, June 17, 08:30-18:30 CET

Abstract Title: “Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment (COMPLETE), a New International Treatment Registry”
Abstract Number: 242
Presentation Date/Time: Thursday, June 16, 08:30-18:30 CET

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 Allos 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 PTCL. Allos is also developing FOLOTYN in other hematologic malignancies and solid tumors. 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.

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.

Contact: Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
or
Madeline Malia, 609-454-0325
mmalia@allos.com

 

Posted: June 2011

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