Aprea: Partial Clinical Hold on Myeloid Malignancy Programs

 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to the Company’s ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial.

There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in the Company’s myeloid malignancy programs, which includes the MDS, AML and post-transplant maintenance trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. Aprea intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.

https://finance.yahoo.com/news/aprea-therapeutics-announces-partial-clinical-210000544.html