December 1, 2004
Delcath Reports Activities During Third Quarter 2004
STAMFORD, Conn., Dec. 1 /PRNewswire-FirstCall/ -- In a quarterly report to shareholders, Delcath Systems, Inc. said patients with inoperable cancer in the liver are continuing to be enrolled and treated with the company's drug delivery technology in two separate clinical trials, one a multi-center Phase III, and the other a Phase II at the National Cancer Institute.
Developed by physicians at the Yale University School of Medicine, Delcath's technology is currently being studied as rescue therapy for patients with liver tumors that have progressed beyond the point of surgical removal. No effective treatments are available for the vast majority of cancers once they reach the liver. Patients diagnosed with liver cancers generally survive only nine months on average.
The Phase III study, currently underway at the Sidney Melanoma Unit of the Royal Prince Alfred Hospital in Sydney, Australia, is testing the widely used cancer drug doxorubicin to treat patients with melanoma tumors in the liver, while the NCI Phase II trial is using high doses of melphalan, another widely used intravenous cancer agent, against a variety of tumor types.
The melphalan study is the NCI's second clinical trial of the company's novel delivery system. Several patients have been enrolled and successfully treated since last September and NCI researchers are continuing to recruit additional patients for the study.
The Phase II trial is treating patients with three different types of liver tumors using a dose level of melphalan six times higher than is customary with conventional intravenous administration. The three different tumors are primary liver cancers, and those that originated as neuro-endocrine tumors or adenoid carcinomas.
Results of a Phase I NCI trial reported earlier this year showed that 60 percent of the evaluable cancer patients treated with high dose therapy through the Delcath system experienced anti-tumor activity, with over half of the responding patients achieving tumor shrinkage greater than 50 percent. If the current NCI study produces consistent positive results, it could accelerate use of Delcath's patented technology for a broader range of cancers than was originally anticipated at this stage.
As previously reported, the company received a draft protocol for a possible third trial at the NCI with the Delcath system.
In a financial update, the company said redemption of all the remaining unexpired warrants issued in conjunction with a May 2003 public offering eliminated a public market instrument reportedly used by traders to hedge short sales of the company's common stock. The Wall Street Journal listed Delcath as having one of the largest short interest decreases in the month of November, falling over 60 percent from October's level.
Subsequent to the quarter's close the company sold $2 million of unregistered common stock in a private placement with institutional investors, bringing current pro forma cash and cash equivalents to over $7 million. The company agreed to file a Form S-3 Registration Statement with the SEC. The investment banking group of H.C. Wainwright & Co. provided professional services in structuring and completing the private placement, performing similarly to their handling of a private placement for Delcath in March of this year.
"H.C. Wainwright has provided sound, professional advice and brought quality investors to the company," said Delcath CEO M.S. Koly. "The latest financing puts us in a stronger position to expand the scope of the research and undertake new projects important to the company."
To speed accrual of patients in its Phase III clinical program, the company hired a new clinical research organization, Kendle International Inc. , a leading global CRO with 1700 associates worldwide. The company said it is also working with the FDA to expand the patient entry criteria to increase the number of patients who can qualify for treatment.
In addition, the Sydney Melanoma Unit has expanded the clinical support team assigned to the study and Principal Investigator Professor John Thompson, MD, remains extremely positive about the Delcath procedure and the prospects of accelerating patient recruitment.
The company continues to be in discussions with several domestic hospitals to expand the Phase III study.
Delcath is a developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Six U.S., 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.
Chief Executive Officer
Delcath Systems, Inc.
Delcath Systems, Inc.
CONTACT: M.S. Koly, Chief Executive Officer of Delcath Systems, Inc.,+1-203-323-8668; or Thomas Redington of Redington, Inc. for Delcath Systems,Inc., +1-203-222-7399, +1-212-926-1733
Web site: http://www.delcath.com/