Allos Therapeutics (NASDAQ: ALTH) has completed patient enrollment a quarter ahead of schedule for their Phase II trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).The pivotal Phase II trial is an international, multi-center, open-label, single-arm study that enrolled patients with relapsed or refractory PTCL who 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 treatment regimen also includes vitamin B12 and folic acid supplementation. 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.
The FDA granted orphan drug designation and fast track designation to PDX for the treatment of PTCL patients, and likewise the Committee for Orphan Medicinal Products of the European Medicines Agency granted orphan medicinal product designation to PDX.
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma in the US. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL. Patients are often treated with multi-agent chemotherapy regimens however, a significant number of these patients relapse or become refractory after treatment with first-line therapy. The average five-year survival for those patients was approximately 25%.
PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. Allos believes these biochemical features, together with preclinical and clinical data in a variety of tumors, suggest that PDX may have a favorable safety and efficacy profile relative to methotrexate and other related DHFR inhibitors and, has the potential to be delivered as a single agent or in combination therapy regimens.
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