GenNBio said Wednesday it has submitted an investigational new drug (IND) application to conduct the phase 1 trial of the xenotransplantation of germ-free pigs’ Langerhans islets to diabetes patients to the Ministry of Food and Drug Safety.
In August last year, GenNBio applied for IND to conduct an investigator-initiated trial (IIT) for the xenotransplantation of Langerhans islets with Seoul National University’s Xenotransplantation Research Center (XRC) and Gachon University Gill Medical Center. The company had held a consultation with the regulator on the IND guidelines for a year. It voluntarily withdrew its application on Aug. 17, accepting the regulator’s views that it is impossible to approve the deadline date of evaluation.
On Tuesday, GenNBio resubmitted its IND application by adding data on the safety of xenotransplantation. Also, instead of applying for the IND as an investigator-initiated trial (IIT), GenNBio decided to submit a sponsor-initiated trial (SIT) to commercialize it, expecting its role to increase given its capability and expertise in xenotransplantation.
“For the past year, we have prepared the additional data and experiments through close collaboration with Xenotransplantation Research Center and Gill Medical Center. As the result of strong partnership, we could make fast IND resubmission,” said GenNBio CEO Kim Sung-joo said.
Kim went on to say, “Our voluntary withdrawal of IND did not mean that our islet xenotransplantation clinical trial is incomplete or insufficient. By cooperating with government agencies and closely examining references, we are establishing a reliable guideline. Based on the ministry’s review results and consultation from experts, we have supplemented many parts of the material.”
It is the world’s first clinical trial following the standards of international organizations like WHO and the International Xenotransplantation Association (IXA). With the establishment of the guideline, it is anticipated Korea can strengthen its grounds as a leader in the market of xenotransplantation products, the company said.
If the IND gets approval, xenotransplantation of pigs’ Langerhans islets will be transplanted to two type-1 diabetes patients. Two years of serial assessment will prove the efficacy and safety of the xenotransplantation and closely monitor adverse effects on patients.
XRC, one of the partners in this IND, has been acknowledged by IXA and The Transplantation Society (TTS) for its Langerhans islet xenotransplantation.
For the IND, GenNBio had organized a research team of global experts of primate xenotransplantation and islet detachment. Kim Kwan-won, chairman of the Korean Diabetes Association and a professor at Gill Medical Center, will lead the clinical trial.