Just shy of 100 patients, Delcath Systems (New York) has completed enrollment in its pivotal Phase III Metastatic Melanoma Trial. The clinical study is poised at evaluating the Delcath Percutaneous Hepatic Perfusion System for the regional delivery of melphalan to the liver to treat patients suffering from metastatic cutaneous and ocular melanoma and who also have unresectable tumors in the liver.

The Wednesday announcement of its enrollment of 92 patients keeps the company on track for a possible 2010 approval for the product, if all goes according to plan and there is a favorable ruling from the FDA. The device is also expected to achieve CE mark approval in 2010.

The PHP system was designed to isolate blood flow from the liver, deliver very high doses of anti-cancer agent, then filter a majority of the agent out of the blood from the treated area.

In an emailed response to Medical Device Daily's queries, the company said "this process allows patients with large and diffuse liver tumors to receive a concentrated, site-specific treatment when other methods are not feasible or have failed to halt the spread of the cancer."

It added that "nothing is implanted permanently. Catheters are placed percutaneously to administer the drug via the hepatic artery and then collect venous effluent from the liver, which is filtered and returned to the patient's bloodstream through the jugular vein."

Blood which exits from the proximal end of the catheter is pumped through two carbon filters before returning to the systemic circulation through the internal jugular vein.

According to the company, the Delcath PHP System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while minimizing entry of the drugs into the rest of the patient's circulation. This isolation limits toxicities which result from systemic chemotherapy treatments. Patients in the trials usually receive the treatment at four-week intervals and up to 10 treatments have been administered to a patient.

Treatments with the device can be performed in an operating room or in a radiology suite under local or general anesthesia. Repeatable Procedure – Unlike surgical isolated hepatic perfusion (IHP), which can be performed only once, PHP can be repeated several times.

The filtration of the hepatic venous effluent can reduce systemic exposure of chemotherapy by 80% to 90% compared to hepatic artery infusion alone.

While the company doesn't claim to be curing cancer with its DS, it said that, unlike surgically isolated hepatic perfusion (IHP) which can be performed only once, this procedure (percutaneous hepatic perfusion) can be administered repeatedly over an extended period, thus improving its life-saving potential.

Patients in the Phase III trial are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP System or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by FDA under a Special Protocol Assessment (SPA), patients are permitted to "cross-over" from the best alternative care arm to receive treatment with the Delcath System at the time of disease progression.

"We have achieved several key, strategic milestones, including the successful review of our Phase III safety data, orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma, and the additions of David McDonald as CFO (Medical Device Daily, September 15, 2009) and Krishna Kandarp MD as CMO and EVP of Research and Development (MDD, October, 5, 2009) Eamonn Hobbs, President/CEO of Delcath Systems said in a statement.

He added that "[Delcath] also executed on our plans to build our own manufacturing facility, which we will continue to develop as we focus for the remainder of the year on preparation for our FDA submission, commercialization and international licensing."

Omar Ford, 404-262-5546;