相关临床试验
47
32 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
1997
进行中（未招募）
31
66.0%
已完成
14
29.8%
尚未招募
1
2.1%
撤回
1
2.1%
暂无批准数据
- 4SC AG has filed for marketing authorization of Resminostat with the EMA for advanced cutaneous T-cell lymphoma, marking a key regulatory milestone. - RESMAIN study data showed Resminostat significantly improved progression-free survival in CTCL patients, with a median PFS of 8.3 months compared to 4.2 months for placebo. - Despite positive clinical data and cost reductions, 4SC AG reported a loss of nearly EUR4 million in H1 2024 and will not pursue US registration based on FDA feedback. - The company is actively seeking commercialization partners in the EU and anticipates addressing EMA questions to refile its submission in late 2024.
- 4SC AG secured a Paediatric Investigation Plan (PIP) waiver from the UK MHRA for resminostat (Kinselby) in advanced-stage cutaneous T-cell lymphoma (CTCL). - The waiver streamlines 4SC's Marketing Authorisation Application in the UK by eliminating the need for pediatric clinical trials, saving time and resources. - Resminostat, an oral maintenance treatment, is under review by the EMA, with filings in preparation for the UK and Switzerland, and a pre-NDA meeting request submitted to the FDA.
- Resminostat, developed by 4SC AG, has been granted Orphan Drug Designation by the EMA for treating cutaneous T-cell lymphoma (CTCL). - This designation provides 4SC with benefits such as protocol assistance, market exclusivity, and fee reductions in the European Union. - The RESMAIN trial demonstrated resminostat's efficacy in improving progression-free survival in advanced CTCL patients, showing a 38% risk reduction compared to placebo. - Resminostat has also received Orphan Drug Designation from the FDA, strengthening its potential for commercialization in major markets.
- Resminostat combined with FOLFIRI chemotherapy demonstrates a manageable safety profile and encouraging clinical activity in patients with advanced, KRAS-mutant colorectal cancer (CRC). - A Phase I study confirmed resminostat's tolerability up to 800 mg daily with FOLFIRI, showing disease stabilization in a subset of patients treated for extended periods. - Analysis of Phase II trials in liver cancer (HCC) and Hodgkin lymphoma (HL) suggests ZFP64 gene expression as a potential biomarker for resminostat treatment response. - Higher baseline ZFP64 expression levels correlated with increased clinical benefit and longer overall survival in HCC and HL patients treated with resminostat.
