STAMFORD, Conn., May 24, 2005 (PRIMEZONE) -- Delcath Systems, Inc. (Nasdaq:DCTH) said results of the National Cancer Institute's study of the company's system for delivering high-dose chemotherapy for treatment of liver malignancies were published in the current issue of the Journal of Clinical Oncology (Vol.23, No.15).
The paper, titled "Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemofiltration Using Percutaneously Placed Catheters In Patients With Unresectable Hepatic Malignancies," is the first comprehensive report on the NCI's initial study of the Delcath system, a dose-finding trial of patients with inoperable cancer in the liver.
Almost half the patients treated in the study had metastatic melanoma in the liver, including both ocular and cutaneous melanomas. In response to a request by Delcath, the U.S. FDA recently granted fast-track status to the clinical development and review of the Delcath system for treating metastatic melanoma in the liver with melphalan.
"We are extremely pleased with the publication of this important peer-reviewed paper and the conclusions of the authors regarding the potential of the Delcath system," said M. S. Koly, Delcath's chief executive officer.
He added, "Although several abstracts have been published on preliminary results of the NCI Phase I study, publication of results in the Journal of Clinical Oncology will reach a much broader audience of oncologists and will accelerate the medical community's knowledge and acceptance of our promising technology."
The findings are consistent with and build on results reported at several major medical symposia, including the American Society of Clinical Oncology (ASCO), the Society of Surgical Oncology (SSO), the Society of Interventional Radiology (SIR), and the Gastrointestinal Cancers Symposium.
The chief purpose of the study was to determine the maximum safely tolerated dose of melphalan delivered to the liver by the Delcath system. The dose was determined to be 3mg/kg, six times higher than generally used in conventional IV administration of the widely used drug.
The paper reported that although the study was not designed to evaluate response, the researchers observed anti-tumor activity, including minor responses, in two-thirds of the 27 evaluable subjects. Thirty percent of the patients had an objective tumor response (a partial or complete response), and patients with metastatic ocular melanoma in the liver, the study's largest group, experienced an objective tumor response rate of 50 percent.
The publication in the Journal of Clinical Oncology evidences the NCI's continuing interest in evaluating the clinical utility of the Delcath system. The NCI earlier this year launched a second study with Delcath-melphalan therapy, a Phase II trial treating patients with inoperable primary and metastatic tumors in the liver.
The NCI said the Phase I study confirmed that delivery of melphalan via the Delcath system is feasible, with limited manageable toxicity, and provided evidence of substantial anti-tumor activity. "We have demonstrated the ability to limit toxicity while delivering high levels of intra-hepatic melphalan ...," the authors wrote.
The Delcath system was developed by physicians at the Yale University School of Medicine as a rescue therapy for patients with inoperable cancers lodged in specific organs such as the liver, the current focus of the NCI studies.
The paper was authored by James F. Pingpak, Steven K. Libutti, Richard Chang, Bradford J. Wood, Ziv Neeman, Anthony W. Kam, William D. Figg, Souping Zhai, Tatiana Beresneva, Geoffrey D. Seidel, and H. Richard Alexander.
About Delcath
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.
This release contains "forward-looking statements" based on current expectations but involving known and unknown risks and uncertainties. Actual results or achievements may be materially different from those expressed or implied. Delcath plans and objectives are based on assumptions involving judgments with respect to future economic, competitive and market conditions, its ability to consummate, and the timing of, acquisitions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond its control. Therefore, there can be no assurance than any forward-looking statement will prove to be accurate.