Delcath Systems, Inc. Provides Update on Corporate Developments Data Release from Phase III Metastatic Melanoma Trial Still Expected in April FDA Submission Timeline Remains on Schedule
NEW YORK, March 12 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. , which is testing its proprietary treatment system for primary and metastatic cancers to the liver, today provided an update on recent corporate developments.
Recent Highlights
"Since mid-November, our team has focused on executing our strategies to gain regulatory approval to market the Delcath PHP System both in the U.S. and in Europe, expand the potential benefits of the Delcath PHP System to patients worldwide and build increasing returns to our shareholders," said Eamonn P. Hobbs, President & CEO. "Overall, we have made significant progress towards our goals and expect to begin the New Drug Application (NDA) process for FDA approval as soon as practically possible."
"The next operational milestone for our company is the April completion of data analysis from our Phase III trial," said Mr. Hobbs. "The trial's data analysis involves the initial review by the principal clinical investigators at each enrolling center, an additional review by the Company's retained Clinical Research Organization, and a final review of medical images for verification of results conducted by an independent core lab before final statistical results are compiled by an independent biostatistical group. We remain highly confident that the trial's data will meet the trial's primary endpoint, and our confidence was recently further buoyed by the FDA's acknowledgement of an expanded access program," added Mr. Hobbs. "Operationally, we are on track to have an inspectable Quality System at our Queensbury manufacturing facility by April, which is a key step in the positioning of the Company for commercialization."
"Our only recent adjustment to our plan has been a revision in our filing schedule to obtain CE Mark in Europe. We recently confirmed that the Delcath PHP System will be treated as a Class III device in Europe, requiring additional validation testing and documentation. We anticipate filing for this approval by the end of the year, or approximately six months later than originally envisioned. Once complete, these data will also be used to complete the CMC module of our rolling NDA submission in the U.S. All other approval timelines are expected to remain on track," said Mr. Hobbs.
"We continue to actively negotiate strategic partnership transactions similar in structure to the agreement recently reached with Chi-Fu Trading Co. for the Taiwan market. Our goal is to execute additional partnerships that will serve both strategic and financial needs. These partnerships will provide distribution and expanded clinical indications in key Asian markets as well as strengthen our capital position. Given that the timing of such agreements is unpredictable, we will continue to review other financing options to assure that the company maintains flexibility and is adequately capitalized to execute on the opportunities ahead of us as we move toward commercialization," concluded Mr. Hobbs.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of primary and metastatic liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer agents to the liver while controlling the systemic exposure of those agents. In addition to its fully enrolled Phase III metastatic melanoma study, the Company is currently conducting trials to treat other liver cancers. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
CONTACT: Investors, Doug Sherk or Barbara Domingo, +1-415-896-6820, or
Media, Steve DiMattia, +1-646-201-5445, all of EVC Group, for Delcath
Systems, Inc.
Web site: http://www.delcath.com/