ALTH Allos Therapeutics, Inc. (MM)

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company’s Phase 3 clinical trial of FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with a CHOP-based therapy. The SPA provides FDA agreement that the study design and planned analysis of this Phase 3 trial adequately address the objectives necessary to support a regulatory submission.

“We are pleased to have reached agreement with the FDA on the design of this pivotal Phase 3 trial of FOLOTYN as part of the first line treatment of patients with PTCL,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. “This important study has the potential to support the conversion of our current accelerated approval in the U.S. to a full approval and expand FOLOTYN’s indication to the first-line setting. The study further demonstrates our commitment to the medical community and patients to explore the full potential of FOLOTYN and improve outcomes for patients with PTCL.”

This Phase 3, randomized, multi-center, international clinical trial will seek to establish the safety and efficacy of sequential FOLOTYN versus observation in patients with previously undiagnosed PTCL who have achieved a response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP-based chemotherapy. The co-primary endpoints will be progression-free survival and overall survival. The Company expects to initiate this Phase 3 clinical trial of FOLOTYN in 2011.

In September 2009, FDA granted accelerated approval of FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This approval was based on overall response rate from the Company’s pivotal Phase 2 trial known as PROPEL. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. FOLOTYN is the first and only drug approved by the FDA for this indication. FDA’s accelerated approval program allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. In connection with the accelerated approval, the Company is required to conduct post-approval studies that are intended to verify and describe FOLOTYN’s clinical benefit in patients with T-cell lymphoma. An updated analysis of data from PROPEL was recently published in the Journal of Clinical Oncology.

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 The Company 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 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.

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.

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 Company’s intent and projected timeline to initiate a Phase 3 trial of FOLOTYN in patients with previously undiagnosed PTCL; the potential for this Phase 3 trial to support the conversion of the Company’s accelerated approval in the U.S. to a full approval and expand FOLOTYN’s indication to the first-line setting; 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. Important factors that may cause actual results to differ materially include, but are not limited to, that the Company may experience delays in the initiation and/or completion of its clinical trials, including the planned Phase 3 trial of FOLOTYN in patients with previously undiagnosed PTCL, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that the Phase 3 trial may not demonstrate that FOLOTYN is both safe and more effective than current standards of care; that data from prior preclinical studies and clinical trials of FOLOTYN may not necessarily be indicative of future clinical trial results; that the safety and/or efficacy results of the Phase 3 trial will not support an application for marketing approval in the United States or any other country; that the FDA may initiate proceedings to withdraw the Company’s current accelerated approval for FOLOTYN if the Phase 3 study fails to verify the clinical benefit of FOLOTYN; and the risk that the Company may lack the financial resources and access to capital to fund the planned Phase 3 trial or any additional 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 Form 10-K for the year ended December 31, 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 registered 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.