2023-12-20 09:28:38
“Safety and effectiveness proven by global regulatory agencies”
Entered 2023.12.20 18:28 Views 3 Entered 2023.12.20 18:28 Modified 2023.12.20 18:38 Views 3
[사진=바이젠셀]Vigencell, an immune cell therapy company, has been designated as an orphan drug by the European Medicines Agency (EMA).
The drug (VT-EBV-N), which received orphan drug designation this time, is an immunotherapy drug with indications for Epstein-Barr virus-positive NK/T cell lymphoma.
NK/T cell lymphoma is a tumor that occurs in the NK cell and T cell lineages, which are immune cells. It mainly invades the nose, respiratory tract, gastrointestinal tract, and skin and is characterized by rapid progression. There is currently no standard treatment, and the recurrence rate within two years is as high as 75%. In particular, patients infected with the Epstein-Barr virus have a greatly increased risk of complications.
Vigencell’s VT-EBV-N achieved an overall survival rate of 100% and a 5-year progression-free survival rate of 90% in 10 patients with the disease in phase 1 clinical trials. The drug was administered to 48 patients in phase 2 clinical trials last September and is currently under observation.
VT-EBV-N was designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety in 2019. Vigencell explained that this time, EMA also designated it as an orphan drug, increasing the possibility that it could develop into a new treatment alternative for NK/T cell lymphoma at home and abroad.
EMA-designated orphan drugs are provided with benefits such as protocol support related to approval, various cost deductions, and European market exclusivity for 10 years after launch.
Vigencell CEO Kim Tae-gyu said, “With this EMA orphan drug designation, the safety and excellent efficacy of our treatment have been recognized,” adding, “We are expanding the target market by adding countries or indications for commercialization, while providing a new treatment alternative for domestic and foreign patients. “I will work hard to make this happen,” he said.
Vigencell plans to apply for domestic conditional product approval as soon as phase 2 clinical trials for VT-EBV-N are completed.
Reporter Jang Ja-won
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