Aprea Therapeutics Announces Clinical Hold on Lymphoid Malignancy Program
Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a clinical hold on its lymphoid malignancy study. The FDA’s concerns referred to the safety and efficacy data from the Phase 3 MDS clinical trial. One CLL patient is currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab and has achieved complete remission (CR). Aprea intends to work closely with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.
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Sr. Vice President and Chief Financial Officer
Sr. Vice President and Chief Business Officer
Source: Aprea Therapeutics