2ND site6 Aug 2024 13:11
From June 17th RNS
· Clinical Site Setup: The setup of clinical sites at the University of Pennsylvania ("PENN") and the new medical centre is underway. This multi-step process involves thorough internal reviews by the science review committee and the internal review board of both clinical sites, as well as budget negotiations and logistics planning. The Company continues to work with Prevail Infoworks, a contract research organization ("CRO"), to manage and oversee the planning for the clinical trials.
Expansion into Pediatric Indications:
Pediatric AML and ALL: The Company is seeking to expand the HEMO-CAR-T indication to include pediatric acute myeloid leukemia ("AML") and a subset of pediatric acute lymphoblastic leukemia ("ALL") patients. An amendment to the clinical protocol to include pediatric AML is currently under review by third party experts. If approved, the Company will seek to implement the clinical trials for pediatric AML at the newly established clinical site. This area is of particular concern, and there is an urgent need for effective treatments for these conditions, which the Company believes HEMO-CAR-T will be able to provide.
Will we be notified of the approval, has it been approved. I recall trials to begin by late summer, this is the last official month of summer so hopefully either started or literally just about to.
Update please Vlad.