We are happy to announce our collaboration with Biogenera in their multi-center phase 1 clinical trial for the new orphan drug BGA002, intended for the treatment of aggressive pediatric tumors associated with alterations in the MYCN tumor gene.
BIOGENERA has officially signed an agreement with CVBF (Consortium for Biological and Pharmacological Evaluations) for the monitoring and execution of the Phase I clinical trial for the new orphan drug BGA002, intended for the treatment of aggressive pediatric tumors associated with alterations in the MYCN tumor gene. BGA002 has received orphan drug designation for both SCLC (from the FDA, orphan register: DRU-18- 6260) and NB (from the FDA, orphan register: DRU-17-6085 and the European Medicines Agency (EMA), orphan drug application: EMA/OD/020/12), certifying its potential as a novel therapeutic approach for SCLC and NB. CVBF is part of various European research networks focused on knowledge transfer and scientific excellence, including EPTRI-AISBL which is dedicated to advancing the development of safe and effective new drugs for children.
Furthermore, Oscar Della Pasqua (UCL), member of the Board of Directors at EPTRI, has been involved in the project development phase specifically for the dose rationale and design of a first-time-in-children protocol for the evaluation of MYCN inhibition BGA002 in neuroblastoma (more info here).