The Delcath System ( What it is )
Targeted delivery of high doses of chemotherapy: The Delcath System allows delivery of chemotherapy to the liver and removal of the drug from the blood prior to return of the blood from the liver to the patient's circulatory system. The filtration protects other parts of the body from the harmful side-effects of chemotherapy, and allows for much higher doses of drug and, potentially, improved efficacy.
Phase III trials underway at NCI: The Phase III protocol received Fast Track designation from the FDA and the trial is being conducted under a Special Protocol Assessment (SPA). Delcath will be expanding this trial to multiple centers to accelerate enrollment and increase awareness.
5-year CRADA in place: In March 2007 Delcath Systems and the NCI expanded their Cooperative Research and Development Agreement (CRADA) for an additional five years, allowing for collaboration in the joint development and evaluation of the Delcath system, to continue Phase II and III clinical trials and to evaluate additional agents for use with the Delcath system.
Repeatability of process, potential with other agents and organs: Unlike regional delivery of chemotherapy to the liver which requires a surgical procedure, the Delcath system is non-invasive and, therefore, is repeatable. The Delcath system’s versatility provides it the potential to be used with different therapeutic agents including oxaliplatin and interferon, and for the isolated treatment of cancers in limbs, the kidney and pancreas.
New management team brings focus: Delcath has a new, experienced and capable management team dedicated to advancing development of the Delcath system. Strategic business experience will be instrumental in building the company and capitalizing on its technology assets.
SharonB
