Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of specialized cell therapies, today announced that it has received a Paediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for C-Cure®, the Company’s lead product-candidate currently in Phase III clinical development for the treatment of ischemic heart failure.
As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a Paediatric Investigation Plan (PIP) outlining the Company’s strategy for investigation of the new medicinal product in the paediatric population. In some instances, a waiver from developing a PIP for certain conditions may be granted by the Agency.
Cardio3 BioSciences received from the EMA an official, product-specific paediatric waiver for C-Cure® across all subsets of the paediatric population for the treatment of ischemic heart disease. As medical and surgical treatments exist for this extremely rare condition among paediatric patients, Cardio3 BioSciences has focused its regulatory approach for C-Cure® regenerative therapy on the adult patient population. Today, the EMA delivered the waiver to Cardio3 BioSciences, hence making it official that the clinical studies would be restricted to the adult population
Christian Homsy, CEO of Cardio3 BioSciences commented: “The PIP waiver represents the first important milestone in the regulatory process in Europe and signifies the completion of one of the mandatory stages that must be completed before Cardio3 BioSciences is able to submit a marketing authorisation for C-Cure® to the EMA. Our company is now well positioned to continue the process toward market authorisation by focusing on the completion of our Phase III clinical trial in adult patients. C-Cure®’s progression toward regulatory approval continues steadily and we look forward to fulfilling additional regulatory requirements to achieve EMA market authorisation for our main cardiac product-candidate.”