PharmaEngine, Inc. announced that Phase 1 clinical study of PEP07 has been approved by Australia HREC and acknowledged by Australia TGA. Indication: PEP07 is a checkpoint kinase 1 (CHK1) inhibitor featuring high kinase selectivity, brain penetrating and oral bioavailability which targets the DNA Damage Response (DDR) network. PEP07 has demonstrated significant single-agent activity and combination potential with standard treatments in preclinical model.

Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): a PEP07 Phase I clinical trial in hematological cancers (e.g., AML or MCL) has been approved by Australia HREC (Human Research Ethics Committee) and acknowledged by Australia TGA (Therapeutic Goods Administration).