Waiver confirms that paediatric studies of certepetide in pancreatic cancer are not needed
Significant clinical trial burden and costs avoided due to waiver
BASKING RIDGE, N.J., May 20, 2024 – Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that it has reached agreement with the European Medicines Agency (the “EMA”) on a Paediatric Investigation Plan (“PIP”) for Lisata’s lead investigational product, certepetide (formerly LSTA1), in pancreatic cancer. The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer.
The Paediatric Committee (“PDCO”) of the EMA recommended and the EMA granted a waiver for certepetide for all subsets of the pediatric population for the treatment of pancreatic cancer on the grounds that “pancreatic cancer occurs only in adults.” This waiver removes any requirement for Lisata to conduct clinical studies of certepetide in children in support of an overall marketing authorization application in Europe for pancreatic cancer. It also allows Lisata to focus its development efforts on bringing this therapy to relevant patients with pancreatic cancer as quickly as possible. By eliminating any requirement for pediatric clinical studies in pancreatic cancer, the waiver significantly reduces the clinical trial burden and overall cost of completing development and achieving market registration in Europe.
“We are pleased that the European Medicines Agency has confirmed that pediatric studies evaluating certepetide are not needed to support a market authorization application in pancreatic cancer,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “With a waiver in hand, we are now able to streamline our development program as we work toward certepetide’s product registration in Europe. This full waiver is specific to pancreatic cancer and will not affect our commitment to evaluate certepetide in other pediatric solid tumors as required.”
In 2007, the European Union implemented the Paediatric Regulation, a landmark change that significantly impacted the development of medicines for children. This regulation aims to increase the research and development of medicinal products; specifically, those applicable to children. A key part of the regulation was the establishment of the PDCO. The PDCO coordinates the EMA’s work on pediatric medicines by determining the study(ies) companies must conduct in children as part of their overall development program for Europe. A PIP is a development plan designed to ensure that the necessary data are obtained through studies in children to support the authorization of a medicine for children. In some instances, a PIP waiver by the PDCO for certain conditions is recommended and then granted by the EMA when development of a medicine for use in children is not feasible or appropriate.
