Wednesday January 16, 9:50 am Eastern Time
Press Release
SOURCE: Delcath Systems, Inc.
Phase III Trial For Delcath Drug Delivery System Planned At New York University Medical School
STAMFORD, Conn.--(BUSINESS WIRE)--Jan. 16, 2002--Delcath Systems, Inc. (Nasdaq: DCTH - news) said The New York University School of Medicine plans to proceed with a Phase III study of the Delcath drug delivery system for cancer in the liver, pending budget approval by NYU and Delcath, and upon approval of the school's Institutional Review Board.
The US FDA has approved the protocol for the study, which will involve treatment of malignant melanoma that has spread to the liver with high doses of doxorubicin, a widely used anticancer agent.
In the final stages of a Phase II trial, 60-80 percent of a small group of cancer patients treated with doxorubicin through the Delcath drug delivery system achieved significant tumor reduction.
The Phase III trial, which will ultimately involve a total of 122 patients, is intended to show that patients treated with the Delcath system experience statistically longer survival rates versus the control group.
The Delcath system is a relatively new advance in perfusion technology. The patented system allows high doses of chemotherapeutic agents to be infused directly into the liver along with the organ's normal blood supply. The procedure is non-surgical and does not interrupt the natural circulation of blood within the patient.
Last year, the National Cancer Institute started a Phase I dose-ranging study using the drug melphalan with the Delcath system, with the hope of replacing the current 6-7 hour surgical perfusion procedure in use at the Institute for the past several years.
In the NCI's surgical procedure, the right and left lobes of the liver are severed from their diaphragmatic attachments and various tubes and clamps are placed to achieve complete vascular isolation of the organ, thus limiting systemic absorption of the anticancer drug. The mean hospital stay for this surgery is reported to be 11 days.
By contrast, the Delcath system is designed to achieve vascular isolation of the organ 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.
Unlike the NCI's surgical procedure, the Delcath treatment is repeatable, so patients who respond to the therapy can continue to receive treatments to keep their tumors in check.
Delcath Systems 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, Connecticut.
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