The Therapeutic Goods Administration (TGA) division of the Australian government has approved Delcath Systems' Hepatic CHEMOSAT® delivery system for listing on the Australian Register of Therapeutic Goods (ARTG).
The proprietary chemosaturation system is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.
The TGA approval allows the company to market and sell the CHEMOSAT system in Australia.
Delcath president and CEO Eamonn P. Hobbs said, "Regulatory approval in Australia represents another achievement for Delcath as we seek to expand the global addressable markets for our CHEMOSAT system."
"We believe chemosaturation therapy via our CHEMOSAT system will provide an important treatment alternative for liver cancer patients in the Australian market," Hobbs added.
The Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer reported positive results, demonstrating disease control and anti-tumour activity.
The trial's primary objectives were to determine the response rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration. Secondary objective measures included patterns of recurrence, progression-free survival and overall survival.
In December 2010, the company submitted the CE Mark Technical File to its European Notified Body to obtain CE Mark approval for the system. The device received European approval for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver in April 2011.
In October 2011, Delcath completed the product notification process through its designated sponsor for the CHEMOSAT system with the Medicines and Medical Device Safety Authority in New Zealand.
Delcath Systems is a development stage speciality pharmaceutical and medical device company focused on the treatment of primary and metastatic liver cancers.