Delcath Cancer Technology Reviewed at Radiology Meeting PR Newswire - April 07, 2004 10:54
STAMFORD, Conn., Apr 7, 2004 /PRNewswire-FirstCall via COMTEX/ -- Speaking at the Society of Interventional Radiology's 29th Annual Scientific Meeting in Phoenix, AZ the end of last month, Anthony W. Kam, MD of the Clinical Center of the National Cancer Institute (NCI) reported that the cancer drug delivery system being developed by Delcath Systems, Inc (Nasdaq: DCTH) has " ... proven to be a safe procedure, supporting continuing further clinical studies using [the system]."
Dr. Kam's conclusions were drawn from a dose-finding study with melphalan at the NCI of 25 cancer patients with inoperable cancer in the liver. The study group underwent a total of 62 treatments with the Delcath system, a novel drug delivery technology that perfuses the liver with high doses of anticancer drug without excessive systemic toxicity.
By way of background, Dr. Kam reminded the audience, "The prevalence, morbidity, and lack of effective systemic treatments for liver tumors (primary and secondary) have spawned efforts to establish more organ-specific techniques. Since the majority of dose-limiting toxicities for systemic chemotherapies are not [liver-related], organ-specific techniques that would prevent systemic exposure could potentially allow for higher dosing regimens for neoplasms of the liver."
Pioneering work to treat inoperable liver tumors with a procedure called isolated hepatic perfusion, or IHP, began more than 40 years ago in Germany, Dr. Kam said, and several institutions are currently using it to treat unresectable liver tumors.
But " ... despite the improved response rates seen in IHP, several drawbacks exist including: mean operative time of greater than eight hours, mean hospital stay of 12 days, an overall mortality of approximately four percent, and treatment limited to a single application," he continued.
Those drawbacks have been essentially eliminated by the Delcath system of percutaneous hepatic perfusion, or PHP, while maintaining the potential efficacy of IHP, he reported.
In describing the Delcath procedure, Dr. Kam said, "[The system] uses a double balloon venous catheter to isolate hepatic venous outflow, allowing regional perfusion of the liver." The blood that flows into the catheter lumen is pumped through a charcoal filtration circuit to remove the toxic chemotherapeutic agent and the cleansed blood is then returned to systemic circulation."
Delcath has a Phase III human clinical trial underway to treat melanoma tumors that have lodged in the liver. The protocol called for treating 61 patients with the drug doxorubicin with 61 in the control group. Separately, the company is working with the NCI to finalize a protocol of a Phase II human clinical study at the NCI with a second cancer drug, melphalan.
Delcath is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Six US, and three foreign issued patents cover its technology. The company is headquartered in Stamford, CT. http://www.delcath.com