Lisata Therapeutics Inc (NASDAQ:LSTA) has received a Paediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for its lead investigational product, certepetide, in pancreatic cancer.
The waiver, recommended by the Paediatric Committee (PDCO) and granted by the EMA, confirms that pediatric studies for certepetide in pancreatic cancer are not required.
It alleviates the necessity for Lisata to conduct pediatric clinical trials for pancreatic cancer and allows the company to focus its development efforts on adult pancreatic cancer patients, significantly reducing clinical trial burdens and costs.
"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, executive vice president of research and development and chief medical officer of Lisata.
The waiver pertains specifically to pancreatic cancer and does not affect Lisata's commitment to evaluate certepetide in other pediatric solid tumors as required.
Lisata continues to develop certepetide, an investigational drug designed to enhance the penetration and effectiveness of anti-cancer drugs in solid tumors.