相关临床试验
5
5 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2018
进行中（未招募）
4
80.0%
尚未招募
1
20.0%
暂无批准数据
- FluoGuide A/S announced a directed share issue of approximately SEK 100 million to fund critical Phase II clinical trials for its lead cancer surgery drug FG001. - The proceeds will support Phase II trials for FG001 in high-grade glioma (HGG) in the US and head and neck cancer, representing the company's first registration trials. - FG001 is designed to improve surgical precision by lighting up cancer tissue intraoperatively, potentially reducing local recurrence and surgical complications. - The funding will also support CMC and manufacturing preparations for a Phase III trial in HGG, marking significant progression toward regulatory approval.
- FluoGuide received positive FDA feedback and alignment on its U.S. clinical study design for FG001, an intraoperative imaging agent for high-grade glioma, during a pre-IND consultation. - The FDA provided alignment on the Phase 2 clinical trial design and key elements of the future Phase 3 clinical program, de-risking the regulatory pathway toward NDA submission. - The company maintains its milestone to submit an IND application for the U.S. Phase 2 clinical registration trial in high-grade glioma by Q4 2025. - FG001 is designed to improve surgical precision by lighting up cancer intraoperatively, potentially reducing local recurrence and surgical complications while enhancing cure rates.
- FluoGuide A/S has submitted a Clinical Trial Application (CTA) for a phase II trial of FG001 in head and neck cancer (oral squamous cell carcinoma). - The trial, designated CT-005, is a single-center study designed to evaluate multiple endpoints of FG001 in patients undergoing surgery. - Enrollment is planned for 25-30 patients, with the first patient expected in Q1 2025, and interim data anticipated in H2 2025. - The trial aims to optimize FG001's positioning for regulatory approval and commercialization, potentially leading to a multi-site registration trial.
