相关临床试验
22
14 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
2008
进行中（未招募）
14
63.6%
已完成
7
31.8%
招募中
1
4.5%
暂无批准数据
- Isofol Medical AB is adding new clinical trial sites, including Essen University Hospital in Germany, to its ongoing phase Ib/II study of arfolitixorin in colorectal cancer. - The expansion follows regulatory approval of an amended study design by German authority BfArM and aims to keep the company on track to enter phase II before year-end. - The phase II segment is planned across 10–15 sites in Germany and additional European countries, complemented by a bridging study in Japan through Solasia Pharma K.K. - Colorectal cancer is the third most common cancer globally and the second most common cause of cancer-related death, underscoring a significant unmet medical need.
- German regulatory authority BfArM has approved an optimized design for Isofol Medical's ongoing phase Ib/II study of arfolitixorin, expanding inclusion criteria from 45% to 90% of colorectal cancer patients. - The phase II portion will now include a control arm for direct comparison with leucovorin, the current leading folate-based medicine, strengthening the trial's robustness. - Study expansion includes additional chemotherapy regimens and will increase from one to 10-15 study centers across multiple European countries to accelerate patient recruitment. - Arfolitixorin is being developed to enhance the efficacy of established cancer treatments for colorectal cancer, the world's third most common cancer with significant unmet medical need.
- The European Patent Office has issued an Intention to Grant notice for Isofol Medical's cancer drug candidate arfolitixorin, providing patent protection until 2043. - The patent covers pharmaceutical compositions comprising arfolitixorin in stable lyophilizate form for clinical use, strengthening the company's intellectual property portfolio. - Arfolitixorin is currently being evaluated in a phase Ib/II clinical study for metastatic colorectal cancer at Charité – Universitätsmedizin Berlin. - Isofol plans to pursue additional patent protection in key regions including the United States and Japan based on positive developments.
- Isofol Medical has received regulatory approval to initiate a Phase Ib/II clinical trial evaluating arfolitixorin in first-line treatment of metastatic colorectal cancer at Germany's prestigious Charité Universitätsmedizin Berlin. - The new study implements an optimized dosing regimen with higher doses administered earlier in the treatment cycle, designed to enhance arfolitixorin's synergistic effects with 5-FU chemotherapy. - The trial will replace leucovorin with arfolitixorin in standard treatment protocols and will be conducted in two stages: dose escalation assessment followed by efficacy comparison between selected dosages.
