Allos Therapeutics Initiates Phase I/II Study Of PDX And Gemcitabine

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Allos Therapeutics announced the initiation of patient enrollment in a Phase I/IIa open-label, multi-center study.

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It will study sequential PDX (pralatrexate) and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's disease.

"We are excited to advance the development of this promising treatment regimen," said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "Based on the clinical activity observed with both of these agentsindividually in patients with relapsed non-Hodgkin's lymphoma, coupled with the encouraging anti-tumor effects of PDX and gemcitabine observed in pre-clinical lymphoma models, we believe that this combination has the potential to be a new treatment for patients with these challenging diseases. This expansion of the PDX development program allows us to evaluate the potential utility of PDX in a broader setting beyond that being evaluated in the on-going pivotal Phase 2 PROPEL trial."

In the Phase I portion of this study, patients with either relapsed or refractory non-Hodgkin's lymphoma (diffuse large B- or T-cell lymphoma, mantle cell lymphoma, transformed large cell lymphomas) or Hodgkin's disease will receive PDX followed the next day by gemcitabine as part of a weekly schedule for three or four weeks with concurrent vitamin B12 and folic acid supplementation. Patients will receive starting doses of PDX and gemcitabine at 15 mg/m2 and 400 mg/m2, respectively, with dose escalation in subsequent cohorts based on toxicity. Up to 54 evaluable patients will be enrolled in the Phase I portion of the study with the objective of determining the maximum tolerated dose (MTD), safety, tolerability, and pharmacokinetic (PK) profile of escalating doses of sequential PDX and

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