Interim results from Allos Therapeutics' FOLOTYN and bexarotene Phase 1 combination study on CTCL

Jan 31 2012

Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported interim results from the Company's ongoing Phase 1 combination study of FOLOTYN^® (pralatrexate injection) and bexarotene in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The combination treatments demonstrated encouraging activity in heavily pre-treated patients (median of 3 prior systemic regimens). Data were presented during an oral presentation at the Fourth Annual T-cell Lymphoma Forum, on January 28 in San Francisco, CA.

Of the 14 patients treated to date, response data were available for 10 patients and 4 patients have not yet reached their first response assessment. Overall, 6 out of 10 patients achieved a response, including one complete response and 5 partial responses. At the maximum tolerated dose, 4 of 7 patients achieved a response, including one complete response and 3 partial responses. Interim data indicates that the combination regimen has been reasonably well tolerated. The most common adverse events (AE) among the 4 patients with AE data available were dizziness, dyspnea, myalgia, mucosal inflammation, and pyrexia.

"We are encouraged by the response rates and tolerability observed at the maximum tolerated dose of the combination FOLOTYN plus bexarotene in heavily pre-treated patients with relapsed or refractory CTCL," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "We look forward to completing patient enrollment of the expanded cohort in order to further inform the design of a planned Phase 3 registration study."