Allos Therapeutics Announces Interim Results From Phase 1 Combination Study Of FOLOTYN® And Bexarotene Demonstrate Activity In Patients With Relapsed Or Refractory Cutaneous T-cell Lymphoma

Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported interim results from the Company’s ongoing Phase 1 combination study of FOLOTYN ® (pralatrexate injection) and bexarotene in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The combination treatments demonstrated encouraging activity in heavily pre-treated patients (median of 3 prior systemic regimens). Data were presented during an oral presentation at the Fourth Annual T-cell Lymphoma Forum, on January 28 in San Francisco, CA.

Of the 14 patients treated to date, response data were available for 10 patients and 4 patients have not yet reached their first response assessment. Overall, 6 out of 10 patients achieved a response, including one complete response and 5 partial responses. At the maximum tolerated dose, 4 of 7 patients achieved a response, including one complete response and 3 partial responses. Interim data indicates that the combination regimen has been reasonably well tolerated. The most common adverse events (AE) among the 4 patients with AE data available were dizziness, dyspnea, myalgia, mucosal inflammation, and pyrexia (n=2 each).

“We are encouraged by the response rates and tolerability observed at the maximum tolerated dose of the combination FOLOTYN plus bexarotene in heavily pre-treated patients with relapsed or refractory CTCL,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. “We look forward to completing patient enrollment of the expanded cohort in order to further inform the design of a planned Phase 3 registration study.”

CTCL is a group of T-cell non-Hodgkin lymphomas. In its early stages, CTCL primarily affects the skin, causing patches, plaques, and tumors, as well as redness and itching; however, as it progresses, CTCL can spread to the blood, lymph nodes, and internal organs. For some patients, their disease will progress despite treatment with topical and skin directed therapies and will require systemic treatments, including chemotherapies. 1-2 Even when CTCL is found in an early stage, it can be difficult to treat and usually returns after initial treatment. 2

About the Study

This ongoing, open label, multicenter, dose-finding, Phase 1 study is evaluating the combination of FOLOTYN and bexarotene in patients with relapsed or refractory CTCL who received at least one prior systemic therapy. The first phase of the study employed a standard dose-escalation design to determine the maximum tolerated dose (MTD). The maximum tolerated dose has been determined to be 15 mg/m 2 of weekly FOLOTYN and 150 mg/m 2 of daily bexarotene. The cohort determined to be the optimal dose/schedule is currently at 14 patients and is being expanded to evaluate FOLOTYN and bexarotene in a total of 30 patients at the MTD.

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 May 2011, the Company entered into a strategic collaboration agreement with Mundipharma International Corporation Limited (Mundipharma) to co-develop FOLOTYN globally. Under the agreement, Allos retains full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries.

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 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. 1-2 The incidence of CTCL is increasing in the United States with approximately 3,000 new cases being diagnosed annually. CTCL affects over 30,000 in the U.S. and Canada. 3

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 approved in the U.S. for the treatment of patients with relapsed or refractory PTCL. 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 B 12 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 potential safety and efficacy of FOLOTYN and bexarotene for the treatment of patients with relapsed or refractory CTCL, the Company’s intent to initiate a Phase 3 registration study of FOLOTYN and bexarotene in patients with relapsed or refractory CTCL; 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 clinical trials may not necessarily be indicative of future clinical trial results; that the safety and/or efficacy profile for FOLOTYN in combination with bexarotene may not support further clinical development in relapsed or refractory CTCL; 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, 2011, 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.

References :
  1. Cutaneous Lymphoma Foundation. Fast Facts: Cutaneous T-Cell Lymphoma. http://www.clfoundation.org/sites/default/files/content/CTCL_2011.pdf. Accessed January 24, 2012.
  2. Cutaneous Lymphoma Foundation. Fast Facts: Sézary Syndrome. http://www.clfoundation.org/sites/default/files/content/Fact%20Sheet_SS.pdf. Accessed January 24, 2012.
  3. Accessed January 24, 2012.Cutaneous Lymphoma Foundation. About Cutaneous T-Cell Lymphoma. http://www.clfoundation.org/about-cutaneous-lymphoma/who-gets-cutaneous-lymphoma-and-how-many-people-have-it. Accessed January 24, 2012.

Copyright Business Wire 2010