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Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
Date:12/27/2007

WESTMINSTER, Colo., Dec. 27 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that an independent Data Monitoring Committee (DMC) has completed the pre-specified 65-patient safety review of data from the Company's pivotal Phase 2 PROPEL trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), and has recommended that the trial continue per the protocol. This interim assessment was based upon an evaluation of patients enrolled in the study who completed at least one cycle of treatment with PDX. The Company currently expects to complete patient enrollment in the PROPEL study in the second quarter of 2008.

"The DMC recommendation represents another important milestone in the development of a potential new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma, a patient population for which there are currently no approved agents," said Pablo J. Cagnoni, M.D., Senior Vice President and Chief Medical Officer of Allos. "We remain pleased with the progress of the PROPEL trial and look forward to continuing to drive our PDX product development and commercialization plans in 2008."

PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral T-cell Lymphoma) is a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll a minimum of 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. Patients receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment. The primary efficacy endpoint of the study is objective response rate (complete and partial response). Secondary efficacy
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SOURCE Allos Therapeutics, Inc.
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