By Daniella Parra
Ascentage Pharma (NASDAQ: AAPG) said it received FDA and EMA clearance for GLORA-4, a global registrational Phase III trial of their Bcl-2 inhibitor lisaftoclax for first-line treatment of higher-risk myelodysplastic syndrome.
The company said it is addressing major unmet needs with the multi-region trial enrolling in US, Europe, and China simultaneously, led by top investigators from MD Anderson and Peking University.
“Globally, we still lack targeted therapies for first-line treatment of patients with higher-risk MDS, which represents a huge unmet clinical need,” Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said. “Currently, hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain the primary treatment options for higher-risk MDS. In earlier studies, lisaftoclax has demonstrated promising clinical benefit and tolerability.”
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