ALTH Allos Therapeutics, Inc. (MM)

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.