Kangstem Biotech said Friday it reapplied for a phase 1/2a IND of Furestem-OA Kit Inj. for osteoarthritis treatment to the Ministry of Food and Drug Safety.
The company reapplied for a phase 1/2a clinical IND about a month after it voluntarily withdrew its original investigational new drug application. At the time, the ministry requested Kangstem Biotech for an exotic virus negative test result. The request was to know that even when test drugs used in clinical trials are manufactured using cell banks, quality and safety are equivalent, and there are no risk factors.
Kangstem Biotech commissioned the test to Charles River, a U.S. testing agency while withdrawing the application. Unfortunately, it wasn't easy to complete the test and analysis within the administrative processing period required to review the clinical trial plan approval application.
“After receiving additional data, we could reapply for phase 1/2a IND on Furestem-OA Kit Inj. in just about a month as we swiftly proceeded with preparations for reapplication by commissioning the test to a well-established institution,” a company official said. “We hope to receive approval to proceed with a clinical trial this year.”
The clinical trial will explore the safety and structural improvement, including cartilage restoration and pain management in osteoarthrosis patients of grades 3 and 4 stipulated by the International Cartilage Repair Society (ICRS) by administering a single dose of Furestem-OA Kit Inj. into the knee joint.
In the phase 1 clinical trial, 18 osteoarthritis patients will be examined for drug resistance and safety against low, medium, and high doses. Phase 2a clinical trial compares two test drug dosage groups for safety in 50 osteoarthritis patients and a placebo group for six months. In addition, the validity at the time of 12 months is to be explored in connection with the long-term tracking survey.
Furestem-OA Kit Inj. is a fusion drug comprised of umbilical cord blood stem cells of the same kind and a heterogeneous cell-free cartilage substrate, which aims to ultimately treat osteoarthritis through a single injection in the knee joint cavity, the company said.
It has secured meaningful data on regeneration and inflammation control of cartilage tissue and meniscus, though it added an animal test modeled on goats.