Delcath Systems has announced that the company has amended its investigational new drug application and its expanded access programme to include the use of the second-generation haemofiltration cartridge of the company’s proprietary chemosaturation system.
The amendments filed with the FDA will permit physicians to use the second-generation system in expanded access and compassionate use cases in selected cancer centres trained in the use of the Delcath system. The amendments also permit the use of the second-generation system in clinical trials the company has planned as part of its clinical development programme. Previously, only the first-generation system used in Delcath’s clinical trials was available for individual compassionate use cases.
Under the expanded access protocol, eligible patients will be able to receive treatment through enrolment at participating cancer centres. These centres will be able to begin treating patients upon receipt of institutional review board approval which the company expects most centres will receive in the third quarter of 2012.
The second-generation haemofiltration cartridge has demonstrated greater efficiency in melphalan removal from the blood in bench-top and in vivo porcine studies. The company believes that if filtration efficiency is validated in clinical use, the second-generation system may significantly reduce melphalan-associated bone marrow toxicity noted in prior clinical trials.
“We believe it is in the best interest of patients to accelerate availability of the second generation filter for investigational uses in the USA,” said Eamonn P Hobbs, president and CEO, Delcath Systems. “We are encouraged by the reports on initial patient treatments in Italy and Germany, where physicians have noted improved side effects and faster recoveries from the procedure after treatments using the new filter as compared to treatments with the first generation filter. In addition to these amendments, we have also initiated discussions with the FDA to determine the optimal approval path for Gen Two and, subsequently, full patient access to the treatment.”
Delcath is in the final stages of preparing the new drug application filing for its proprietary chemosaturation system with the first-generation haemofiltration cartridge.