Mallinckrodt drops futher testing of Therakos to treat young patients with Steroid Refractory Acute Graft-versus-Host Disease
February 21, 2019Mallinckrodt will drop testing its Therakos in the Phase 3 clinical trial for treating young patients with Steroid Refractory Acute Graft-versus-Host Disease, after the interim results were published, the company said Thursday.
The company said that eleven serious adverse events were reported, leading to two subject withdrawals and two deaths; but it said that none were considered related to the Therakos photopheresis therapy.
The study was company-sponsored, Phase 3, single-arm, open-label, multi-center testing the efficacy of treating steroid-refractory, acute Graft-versus-Host Disease (aGvHD) with the Therakos Photopheresis platform in conjunction with liquid methoxsalen.
Steven Romano, M.D., Executive Vice Pr said in the press release that he believes the full details from the study’s interim analysis – which will be made public – will make a meaningful contribution to the body of data related to this critical condition.
