- Clinical hold on SEL24
On 7 October 2017, Selvita announced that the FDA has placed a full clinical hold on the company’s open-label, dose escalation Phase I/II clinical trial with SEL24 (dual PIM/FLT3 kinase inhibitor) in patients with relapsed/refractory acute myeloid leukemia (r/r AML). The decision was based on a fatal haemorrhagic stroke after venous thrombosis in one patient enrolled in the last cohort 5 in part 1 of the study designed to establish the recommended dose. The adverse event was classified as possibly related to the study treatment, which prompted the FDA to issue the clinical hold.Ryvu Therapeutics SA, formerly known as Selvita SA, is a Poland-based company engaged in the healthcare industry. The Company is active in the pharmaceutical and biotechnology fields. It operates through two business segments. The Innovative segment develops new drugs mainly for oncology and central nervous system diseases. The Services segment is engaged in the research and development activities, such as introducing substances on the market, client service and reducing the risk. The Company's portfolio encompasses projects, including kinesis inhibitors platform, the platform of the metabolism for the cancer and epigenetic, among others. Ryvu Therapeutics SA is active in the domestic market and internationally, such as in the United States. It operates through unit Ardigen SA and SORS Holdings Ltd.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.
.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.