STAMFORD, Conn., June 9, 2005 (PRIMEZONE) -- Delcath Systems, Inc. (Nasdaq:DCTH):
Mid-Year Report
To Our Stockholders:
I am sure most of you are aware of the recent notice we received from the US FDA granting fast-track status to the Delcath system for treating melanoma malignancies in the liver with melphalan. It was clearly the single most significant event for the company since our IPO in October 2000, not to mention its potential importance to patients with inoperable cancer in the liver. Our next step is to prepare a protocol that defines, among other things, the method of testing, the number of patients, and the clinical endpoints under fast-track provisions.
The National Cancer Institute's interest in our technology was instrumental in the FDA's most recent decision. The NCI began investigational studies using melphalan with the Delcath system in late 2001, about a year after our IPO, as an experimental treatment for inoperable cancers in the liver. The NCI was interested because for seven years it had been performing a highly invasive surgical procedure to achieve the same therapeutic benefit provided by the minimally invasive Delcath system. Given the option of a less invasive procedure, the NCI, under the leadership of H. Richard Alexander, MD, chief of the NCI's Metabolic Surgery Section, was extremely interested in investigating the potential utility of the Delcath system.
The study's very positive results were presented at several major medical symposia and were published in the May 20, 2005 issue of the Journal of Clinical Oncology, authored by researchers at the NCI.
The events that led to the fast-track status took a more formal turn earlier this year when, equipped with positive preliminary results from the NCI's study, we initiated discussions with the FDA concerning ways to facilitate a more expeditious approval of the Delcath system.
On March 31, 2005 we met with several senior officials of the FDA. Present for Delcath were the chairman, the chief executive officer, our medical director, the company's FDA counsel, and Dr. Alexander of the NCI. Our goal was to present evidence to the FDA that organ-specific chemotherapy with the Delcath system has shown promise and should be accorded new considerations.
The FDA's early May decision to grant fast-track status to the clinical development and review of the Delcath system for treatment of melanoma malignancies in the liver with melphalan was one of the initial outcomes of these discussions.
Our efforts to develop the data package for FDA approval have been underway in earnest since our IPO in late 2000 when we unfortunately netted only a third of what we planned to raise. Nonetheless, this time period has been relatively short compared to the development timelines for most medical products. And by normal standards, the company's "burn," or money expended during those five years, has also been relatively modest, totaling approximately $11 million. We are continuing to take actions to speed the clinical and regulatory approval processes. Naturally, our expenses will increase in the months ahead as we accelerate our clinical programs.
/s/ M.S. Koly President & Chief Executive Officer June 9, 2005
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.