Delcath Systems Inc (DCTH)

[Rapture2020]

Delcath Announces Preliminary Safety Analysis for Phase 3 Focus Trial

“The DSMB’s recommendation to proceed without modification with the FOCUS Trial as planned confirms our own observations of the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. “Importantly, this initial independent evaluation of the safety profile of melphalan/HDS used the Generation Two filter configuration of the device and the current version of the procedure protocol, and so provides confidence in both our product and procedure. Given that safety concerns with the previous generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased to have successfully passed this important milestone.



http://delcath.com/reuters-news/?id=2323336