Allos Therapeutics (NASDAQ: ALTH) announced positive interim data from their Phase I dose optimization study of PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The data demonstrated activity in a range of doses, and will continue with the objective of determining the optimal dose and schedule for patients with CTCL.
Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15-30 mg/m2 as part of a weekly schedule for two or three weeks followed by one week of rest. Patients received a median of three prior systemic therapies. Investigator-assessed responses were observed in 7 of 14 evaluable patients, including two complete responses and five partial responses. Responses were observed in all four treatment cohorts. The most common adverse event was mucositis.
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