Allos Therapeutics has announced the interim results from the ongoing Phase 1 combination study of Folotyn (pralatrexate injection) and bexarotene in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Discovered by Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute and developed by Allos Therapeutics, Folotyn is a folate analogue metabolic inhibitor.
The open label multicentre dose-finding Phase 1 study is investigating the combination therapy of Folotyn and bexarotene in patients with relapsed or refractory CTCL who received at least one prior systemic therapy.
In the first phase of the study, a standard dose-escalation was employed to demonstrate the maximum tolerated dose (MTD) and has been determined to be 15mg/m2 of weekly Folotyn and 150mg/m2 of daily bexarotene.
The study showed that the combination treatments demonstrated encouraging activity in heavily pre-treated patients, and at the MTD, four of seven patients achieved a response, including one complete response and three partial responses.
Allos Therapeutics chief medical officer Charles Morris said the study reported encouraging response rates and tolerability at the MTD with the Folotyn combination therapy in patients heavily pre-treated with relapsed or refractory CTCL.
"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," Morris added.
The company has signed a strategic collaboration agreement with Mundipharma International Corporation (Mundipharma) to co-develop Folotyn globally, under which Allos retains full marketing rights for Folotyn in the US and Canada, with Mundipharma having exclusive rights to commercialise Folotyn in all other countries.
In early stages, CTCL affects the skin, causing patches, plaques, tumours, as well as redness and itching.
As it progresses, it can spread to the blood, lymph nodes and internal organs.
Allos Therapeutics is a biopharmaceutical company focused on the development and commercialisation of innovative anti-cancer therapeutics.
Image: Micrograph showing cutaneous T-cell lymphoma. Photo: Nephron.