Hepatic Chemosat Delivery System was used to treat the first patients at the European Institute of Oncology (Instituto Europeo di Oncologia – IEO), Milan, Italy, announced Delcath System.
Two patients with inoperable liver-dominant metastases from ocular melanoma and gastric cancer were treated with the Generation One version of Chemosat system, and there were no procedure-related complications.
“The Chemosat system represents an important advancement in treatment options for cancers in the liver, which have significantly poorer survival rates compared to cancers that have spread predominantly to other organs. We believe this technology will help fill an important gap in the treatment of multiple tumor types in the liver because of its demonstrated ability to deliver concentrated doses of chemotherapeutic agent directly to the liver while helping to minimize systemic exposure. We are pleased to be the first center in Europe to begin offering this treatment to patients and look forward to exploring its potential with Delcath,” said Dr. Alessandro Testori, surgical oncologist and director of the Division of Melanoma and Skin-Muscle Sarcoma at the IEO.
Chemosat is a medical device that utilizes chemosaturation technology.
This procedure supplies high doses of chemotherapeutic drugs directly to the liver and minimize the exposure of other organs to the drug. It can be repeated since it is a minimally invasive procedure.
Chemosat received CE Mark in April 2011 as a Class III medical device with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
“Since obtaining our CE Mark, Delcath has been committed to supporting the technology in the substantial international liver cancer market. These cases represent the first uses of Chemosat outside of a clinical trial—an exciting milestone for Delcath. There is no greater endorsement for Chemosat than to have the first European patients treated at an organization as prestigious as the IEO. We are delighted that the procedures were successfully performed, and look forward to continued collaborative progress with the IEO and the opportunity to open additional Chemosat treatment centers across Europe,” said Eamonn P. Hobbs, president and CEO of Delcath.
The Generation Two version of Chemosat is under review for CE Mark approval by the Notified Body.
On February 15, 2012 the IEO and Delcath will host a joint-press conference, at the IEO, and an update on patient status will be presented.
The cases were treated as part of the initial launch and training agreement with the IEO.
Chemosat is an investigational product in the United States and is not approved by the U.S. Food and Drug Administration.