Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL

Smart Immune

10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre.

Smart Immune announced today that its investigational new drug for acute lymphocytic leukaemia and acute myelocytic leukaemia has been accepted by the FDA. 

The FDA has also granted SMART 101 fast track designation under its expedited program for serious conditions.

Read Smart Immune press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Australia , Fast track