Posted by Michael Wonder on 11 Nov 2020
Angiocrine Bioscience announces FDA regenerative medicine advanced therapy designation granted to AB-205 (universal E-CEL cell therapy) to treat organ vascular niche injuries for the prevention of severe toxicities in lymphoma patients undergoing curative high-dose therapy with autologous stem cell transplantation
11 November 2020 - Angiocrine Bioscience today announced that the U.S. FDA granted the regenerative medicine advanced therapy designation for AB-205, for the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities in patients with Hodgkin's lymphoma and non-Hodgkin's lymphoma undergoing high-dose therapy and autologous haematopoietic stem cell transplantation.
Based on its Phase 2 trial results, Angiocrine expects to initiate a single pivotal registration Phase 3 trial in 2021 involving leading cancer centers in North America and Europe.
