STAMFORD, Conn., June 15, 2005 (PRIMEZONE) -- Delcath Systems, Inc. (Nasdaq:DCTH) reported shareholders attending the company's 2005 annual meeting voted in favor of the re-election of Samuel Herschkowitz, MD, chairman, and M. S. Koly, chief executive officer, as directors for the term that will end at the company's 2008 annual meeting.
In remarks following the official proceedings, Mr. Koly reviewed events of 2004, saying the company has never been in better financial condition to proceed with clinical trials in seeking FDA approval of its drug delivery system.
"We have brought in over $7 million in working capital through the exercise of stock options and warrants and through private placements with highly qualified investors in order to continue our clinical trials and product development," he said. "The funds raised will provide sufficient capital to continue to conduct our current human clinicals as we proceed as quickly as possible through the FDA phases on our road to approval and marketing of the Delcath technology. Our new investors are obviously showing confidence in the potential of our technology and in the future of our company."
In reviewing the company's clinical activities, Mr. Koly reported that investigators at the National Cancer Institute have made multiple professional society presentations on a Phase I Delcath study and submitted an article to the prestigious Journal of Clinical Oncology, which was recently published. "Subsequent to submission of the article, which occurred last fall, the NCI presented very positive survival data," he said. "While that data is not included in the publication, the article does explain the NCI's continued enthusiasm for the Delcath treatment."
The NCI has subsequently begun treatment of patients in a Phase II study, infusing high doses of melphalan through the Delcath system. This study involves patients with primary liver cancer, neuro-endocrine tumors and metastatic adenocarcinoma in the liver, including liver metastasis from colorectal cancer.
Recently, the U.S. FDA granted the company "fast-track" approval in order to speed human testing of the Delcath delivery system using melphalan specifically to treat melanoma that had spread to the liver. Fast-track approvals are granted by the FDA to those therapies that show promise against a life-threatening disease with no alternative therapy or with an unmet medical need. "This is quite a positive step for Delcath," Mr. Koly noted.
He added, "Of the two drugs being tested with the Delcath delivery system, melphalan in Phase II and doxorubicin in Phase III, melphalan is the one that received the fast-track approval and, in the pace of clinical testing, may overtake doxorubicin."
In response to a question, Seymour Fein, MD, Delcath's medical director, noted that the NCI's studies have no control group, whereas the company's ongoing Phase III trial with doxorubicin requires random assignment of patients to a control group receiving standard care, which is largely ineffective. "The control group requirement has been a major impediment in adding sites and in accelerating enrollment in our Phase III program, and we are hopeful that recent discussions with the FDA will work to provide some relief in that area," he said.
In responding to questions about future financing possibilities and the company's publicly traded warrants, Mr. Koly said the board regularly reviews a variety of options but has made no final decisions.
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.