NEW YORK, June 18, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company has amended its Investigational New Drug (IND) application and its Expanded Access Program (EAP) to include the use of the second-generation hemofiltration cartridge of the Company's proprietary chemosaturation system. The amendments filed with the U.S. Food and Drug Administration (FDA) will permit physicians to use the second-generation system in expanded access and compassionate use cases in selected cancer centers trained in the use of the Delcath system. The amendments also permit the use of the second-generation system in clinical trials the Company has planned as part of its Clinical Development Program. Previously, only the first-generation system used in Delcath's clinical trials was available for individual compassionate use cases.
Under the Expanded Access Protocol, eligible patients will be able to receive treatment through enrollment at participating cancer centers. These centers will be able to begin treating patients upon receipt of institutional review board (IRB) approval which the company expects most centers will receive in the third quarter of 2012.
The second-generation hemofiltration cartridge has demonstrated greater efficiency in melphalan removal from the blood in bench-top and in vivo porcine studies. The Company believes that if filtration efficiency is validated in clinical use, the second-generation system may significantly reduce melphalan-associated bone marrow toxicity noted in prior clinical trials.
"We believe it is in the best interest of patients to accelerate availability of the second generation filter for investigational uses in the U.S.," said Eamonn P. Hobbs, President & CEO of Delcath Systems. "We are encouraged by the reports on initial patient treatments in Italy and Germany, where physicians have noted improved side effects and faster recoveries from the procedure after treatments using the new filter as compared to treatments with the first generation filter. In addition to these amendments, we have also initiated discussions with the FDA to determine the optimal approval path for Gen Two and, subsequently, full patient access to the treatment."
Delcath is in the final stages of preparing the New Drug Application (NDA) filing for its proprietary chemosaturation system with the first-generation hemofiltration cartridge.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath announced that its randomized Phase III clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Delcath Hepatic CHEMOSAT® delivery system in April 2011 and for the second generation hemofiltration cartridge for CHEMOSAT in April 2012. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at www.delcath.com.
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: future use of the second generation hemofiltration cartridge in the Expanded Access Program and clinical trials in the United States, the benefits of the Generation 2 CHEMOSAT system and market acceptance of the same, patient outcomes using the Generation 2 system, the timing of the supply and distribution of the CHEMOSAT system to early launch centers in Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, , the timing and use, if any, of the line of credit from SVB, and our ability to access this facility, 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.
Doug Sherk/Gregory Gin
SOURCE Delcath Systems, Inc.