BioArctic AB announced the company has received approval by Fimea and Valvira, as well as the local ethics committee for inclusion of Finnish patients in BioArctic's ongoing clinical Phase 1/2 study with SC0806. The candidate product is a combination of a medical device (implant) and a medicinal product (FGF1) for patients with complete spinal cord injury. This approval means that BioArctic has received approvals in all the countries planned to participate in the study, i.e. Sweden, Estonia, Norway and now Finland.
The Finnish patients will undergo treatment with SC0806 in Sweden followed by an 18-months rehabilitation period in Finland to enhance the patients' motor ability in the paralyzed part of the body. The treated patients will also be offered 12 month's further participation in an extension study.
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"Today there is no effective treatment available for patients suffering from complete spinal cord injury. In April of this year, the inclusion of patients with complete spinal cord injury was completed in the first panel of BioArctic's ongoing Phase 1/2 study. We are pleased to be able to include patients from Sweden, Estonia, Norway and now also Finland to participate in the study's next panel. Our ambition is to develop SC0806 to improve the quality of life for these patients," said Gunilla Osswald, CEO of BioArctic.