Updated data from Allos Therapeutics' ongoing FOLOTYN study

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). These data were showcased during an oral presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

Data were presented on 31 patients with relapsed or refractory CTCL who received a median of 4 prior systemic therapies. The dosing regimen of 15 mg/m² weekly for three weeks out of a four-week cycle was determined to be the optimal starting dose and schedule that provided activity with tolerability. In this dose de-escalating study, 18 patients who received FOLOTYN at the optimal dose or higher, responses were observed in 11 patients (61%). In the overall study, which included doses lower than the optimal dose, responses were observed in 12 patients (39%), including two complete responses and nine partial responses in patients who received FOLOTYN. An expansion cohort at the optimal dose of 15 mg/m² weekly for three out of a four week cycle is actively enrolling.

“We really need new therapies for our patients with relapsed or refractory CTCL,” said Steven Horwitz, M.D., assistant attending, medical oncologist, Memorial Sloan-Kettering Cancer Center, who is serving as the study chair. “We are encouraged by the responses we’ve seen so far. Many of these patients have had excellent responses, even at relatively low doses of pralatrexate.”