Invossa is safe, claims a paper published in U.S.Invossa is safe and effective, according to a research paper published in a U.S. journal.
The drug lost its approval in Korea and was withdrawn from clinical trials in the United States earlier this year after it was discovered that kidney cells rather than cartridge cells were used in the making of the gene therapy.
The paper, published in Surgical Technology International Thursday, said that the gene therapy drug for knee osteoarthritis has caused no lethal side effects and proved its efficacy through years of clinical trials and patient injections.
“The Safety and Efficacy of a Novel Cell-Based Gene Therapy for Knee Osteoarthritis” was authored by Dr. Javad Parvizi, director of clinical research at Rothman Orthopedic Institute of Philadelphia; Dr. Michael Albert Mont, former associate professor of orthopedic surgery at Johns Hopkins Hospital of Baltimore; and two more researchers.
“Due to a misidentification error, there have been concerns that this cell-based gene therapy is based on a different cell than the one that was initially approved,” the abstract said.
The report disclosed that Parvizi and Mont had participated in Invossa’s clinical trials in the United States until Kolon Life Science suspended the clinical trials for the drug in April.
“However, its safety profile has been demonstrated by over 10 years of data revealing no evidence of tumorigenicity or other long-term safety concerns. In all studies to date, there have been no treatment-related serious adverse events. Although the nomenclature of one component of the drug product has changed, the product itself has not.”
Invossa, approved by Korean authorities in 2017, was taken off the market last month after it was found that Kolon Life Science filed false documentation for its approval. Invossa was approved on the basis that cartilage cells were used, not kidney cells.
Since the errant cell line was discovered, some patients and civic groups claimed that kidney cells could cause tumors in patients, but the recent report said the concerns were unfounded as radiation has been used on the drug to prevent its cells from multiplying out of control.
The report added that it hopes Invossa will continue to be used in treatments and research as the efficacy and safety of the drug has been proved.
Currently, Kolon Life Science is working to resume Phase 3 clinical trials for Invossa in the United States while holding meetings with Invossa-injected patients, promising to track their health over the next 15 years.
BY KO JUN-TAE [firstname.lastname@example.org]