After finalising the Preclinical Phase with extremely promising results, we have initiated the Clinical Phase 2a. We are currently studying the security of CEB-01 in the indication of Soft Tissue Sarcomas (STS) with adult patients at Hospital de la Santa Creu i Sant Pau in Barcelona.
We will conduct the studies with 9 out of 21 adults before starting the studies with paediatric patients, meeting the strict security requirements from the EMA (European Medicines Agency). Once these are finalised, we will be able to initiate the clinical studies with paediatric patients alongside Sant Joan de Déu Barcelona Children’s Hospital.
“We have initiated the clinical studies in adults after meeting all the medical and technological requirements demanded by the AEMPS (Spanish Medicines and Medical Products Agency).”
Jose Antonio Tornero, CTO y cofundador de Cebiotex
CEB-01 has finalised the Preclinical Phase. In January 2020 we received the approval from the AEMPS (Spanish Medicines and Medical Products Agency) to start the Clinical Phase 2a, in which we have already started the clinical trials with adult patients at the Hospital de la Santa Creu i Sant Pau in Barcelona, highly distinguished in Spain for Soft Tissue Sarcomas (STS).
We have received the GMP (Good Manufacturing Practices) certification by the AEMPS and for the production of CEB-01, and we hold an Orphan Drug Designation (ODD) from the European Union for CEB-01 in Soft Tissue Sarcomas.