DMC RECOMMENDS THAT ALLOS CONTINUE ITS LYMPHOMA TRIAL

Allos Therapeutics announced that an independent data monitoring committee (DMC) has completed a planned interim analysis of safety data from the company's pivotal Phase II 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 on an evaluation of the first 10 patients enrolled to the study who completed at least one cycle of treatment with PDX. No major patient safety concerns were identified by the DMC.

PROPEL is a Phase II, international, multicenter, open-label, single-arm study that will seek to enroll 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 endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival. In August 2006 the company announced that it reached agreement with the FDA under the special protocol assessment process on the design of this pivotal trial. In October the FDA granted fast-track designation to PDX for the treatment of patients with T-cell lymphoma.

In accordance with the study's design, another interim analysis of efficacy data will be conducted after 35 patients have completed one cycle of treatment with PDX, which is currently expected to occur in the second half of 2007. The DMC will assess patient safety as part of the 35-patient response assessment and again after 65 patients have completed one cycle of treatment. The company currently anticipates that patient enrollment at up to 35 centers in the U.S., Canada and Europe will be completed by the third quarter of 2008.

PDX is a novel, small-molecule chemotherapeutic agent that inhibits dihdrofolate reductase, a folic acid dependent enzyme involved in the building of DNA and other processes.