STAMFORD, Conn., Jan. 4 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. announced today that the National Cancer Institute (NCI) will name Dr. James F. Pingpank, Jr. as the Principal Investigator for Delcath’s clinical trials at NCI, following the departure of Dr. H. Richard Alexander. Dr. Alexander has accepted a senior post at the University of Maryland, and will be leaving his current position with the NCI in February 2006.
Dr. Pingpank provides continuity for the NCI with Delcath as they maintain their position as the lead site for the Company’s upcoming Phase III clinical trial for the treatment of metastatic melanoma in the liver using the Delcath system with melphalan, an approved anticancer agent. Dr. Pingpank is a Senior Investigator in the Surgery Branch at NCI. He participated as a co- investigator since the inception of Delcath’s Phase I trial in 2001, and was the lead author of the May 2005 Journal of Clinical Oncology article.
Dr. Alexander will assume the role of Associate Chairman of Clinical Research at the University of Maryland School of Medicine in Baltimore, as well as Professor of Surgery, effective March 1, 2006. Currently, Dr. Alexander is Head of the Surgical Metabolism Section and Senior Principal Investigator at the National Cancer Institute (NCI).
Also, Dr. Alexander has requested Delcath consider allowing the University of Maryland to participate in the Company’s Phase III clinical trial. Should Delcath reach an agreement with the University of Maryland, it will be the second clinical trial site requesting to enroll in the Company’s melphalan clinical trial under the fast-track protocol.
Currently, Delcath is working with the U.S. FDA to receive final approval for the pivotal clinical trial protocol. Once this approval is received, the first site can begin to actively recruit patients for the clinical study.
M.S. Koly, President and Chief Executive Officer of Delcath Systems, said, “We are delighted to maintain our strong ties with both the NCI and Dr. Alexander. We look forward to developing a relationship with the University of Maryland and enhancing our relationship with Dr. Pingpank and the team of investigators at the NCI.”
Dr. James F. Pingpank, Jr. stated, “My expanded role as the Principal Investigator for the NCI’s upcoming clinical trial for Delcath is a great opportunity. The Company’s unique technology provides a targeted, minimally invasive and repeatable form of high dose therapy that has the ability to slow the spread, and actually shrink, cancerous tumors to dramatically improve patient quality of life. The Phase I and II clinical trials for the Delcath system have demonstrated positive results in the treatment of liver cancer and I look forward to continuing our partnership in Delcath’s Phase III clinical trials.”
Dr. Richard Alexander stated, “I have been a major supporter of Delcath’s technology over the past few years and have a strong relationship with the Company’s CEO M.S. Koly. I look forward to continuing to build our relationship as I take my new position at the University of Maryland. I have already taken the initial steps with the Company and the University to host clinical trials for Delcath’s upcoming Phase III trial.”
About Delcath Systems, Inc.
Delcath Systems is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. The Company’s intellectual property portfolio currently consists of 12 patents on a worldwide basis, including the United States, Europe, Asia and Canada.
In May 2005, Delcath received fast-track status from the U.S. FDA for the treatment of metastatic melanoma in the liver with melphalan using the Delcath system. For more information, please visit the Company’s website, http://www.delcath.com.
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.
Delcath Systems, Inc.
CONTACT: Todd Fromer, +1-212-896-1215, tfromer@kcsa.com, or MichaelCimini, +1-212-896-1233, mcimini@kcsa.com, both of KCSA Worldwide, forDelcath Systems, Inc.
Web site: http://www.delcath.com/
