Delcath Systems Inc has received approval from the Therapeutics Goods Administration, Australia's equivalent of the U.S. FDA, to commence a Phase III trial at the Sydney Melanoma Unit for patients with life-threatening cancer in the liver.

Delcath said the TGA's approval completes all authorizations required to begin patient enrollment in the pivotal study. A successful Phase III trial will allow commercialization of the company's novel drug delivery technology.

Last week, the company announced the clinical site's Ethics Committee, which is equivalent to an Institutional Review Board (IRB) at a U.S. hospital, gave its go-ahead to the study, which will treat patients with inoperable liver tumors caused by melanoma metastasis.

The study protocol, which has also been approved by the U.S. FDA, calls for enrolling a total of 122 subjects. The clinical goal is to show that patients treated with Delcath's patented drug delivery system experience statistically longer survival versus a control group. The trial is using the chemotherapeutic drug doxorubicin.

The Sydney Melanoma Unit has accumulated the largest database of melanoma patients in the world and treats an average of approximately 60 new melanoma patients a month. The Melanoma Unit has treated more than 15,000 patients during its 35-year history.

The Delcath system delivers high dose chemotherapy directly to the liver via the hepatic artery, then uses special catheters and filters to direct and trap the toxic chemicals, protecting the rest of the body from excessive toxicity.

The principal investigator of the Delcath trial at Sydney, John Thompson, MD, is a world leader in the development of perfusion and infusion therapies for recurrent melanoma. He serves as director of the Sydney Melanoma Unit and is a professor of surgery (melanoma and surgical oncology) at the University of Sydney.

The Delcath system is also being utilized by clinicians at the National Cancer Institute in Bethesda, MD in a dose finding Phase I study. The preliminary data from this study has been very encouraging and a Phase II trial will be commencing in the near future. Both trials will be using the chemotherapeutic drug melphalan. The NCI is using the Delcath system in place of a successful, but much more invasive procedure that reportedly limits the full potential of isolated perfusion therapy.

The Delcath system achieves vascular isolation of an organ such as the liver in an outpatient setting with a minimally invasive, non-surgical procedure. The system removes the majority of the drug from the blood through a sophisticated catheterization and filtration process.

Delcath is a leading developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Its technology is covered by seven US, and three foreign issued patents. The company is headquartered in Stamford, CT.

The Sydney Melanoma Unit is the clinical unit of the Department of Surgery of the University of Sydney. It was formed in 1968 and it is based at the Royal Prince Alfred Hospital, Camperdown. It is the largest treatment center for malignant melanoma in the world and conducts a wide range of basic and clinical research relating to melanoma. The Unit has a worldwide reputation for the quality of its patient care, research and treatment programs.