Low Side Effects Seen in Treatment With Delcath's Second Generation Hemofiltration Cartridge

Thu Apr 26, 2012 7:38am EDT

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Low Side Effects Seen in Treatment With Delcath's Second Generation Hemofiltration Cartridge

Initial Data from First Treatment with New CHEMOSAT System Show Lower Treatment Related Toxicity Compared to Previous Treatment in Same Patient

PR Newswire

NEW YORK, April 26, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that doctors from the European Institute of Oncology (Instituto Europeo di Oncologia – IEO) presented preliminary data showing reduced side effects in the first treatment using the Company's second generation Hepatic CHEMOSAT® Delivery System as compared to a prior treatment with the first generation system.

The comparison was presented at a sponsored symposium entitled Chemosaturation Therapy – Initial European Experiences hosted by Delcath at the Third European Conference on Interventional Oncology (ECIO, April 25-28) held in Florence, Italy. The session was moderated by Dr. Ricardo Lencioni, Director of Imaging and Diagnostic Intervention at the University of Pisa, and featured presentations by Dr. Pier Francesco Ferrucci, Director of Translational Research on Melanoma and medical oncologist at the IEO, Dr. Franco Orsi, Director of Interventional Radiology at the IEO, and Dr. Thomas J. Vogl, Director of the Institute of Diagnostic and Interventional Radiology at the J.W. Goethe University Hospital in Frankfurt, Germany.

Dr. Ferrucci presented the comparison of side-effect profiles in two CHEMOSAT treatments performed in a single patient. Treatment with the second-generation CHEMOSAT system showed brief mild bone marrow suppression and no significant related toxicities. In the prior treatment of the same patient, which was conducted with the first generation CHEMOSAT system, moderate to severe bone marrow suppression and related toxicities were noted.

"Though we are just beginning to explore the potential of the CHEMOSAT system, we are very encouraged by our initial experiences," said Dr. Ferrucci. "If the side-effect profile seen in our first case with the second generation system can be consistently repeated in subsequent treatments, it would suggest that the second generation CHEMOSAT is a real step forward in the development of this important therapeutic approach  for cancers in the liver."

"We believe that data from this initial case validates the confidence we have in our Gen Two CHEMOSAT system as a result of our in vivo testing," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "We are encouraged by the initial results and although this is only the first case, we're now even more confident that Gen Two will deliver the melphalan removal efficiency shown in our research, resulting in the improved side-effect profile demonstrated in this initial case. As more centers in Europe become familiar with the CHEMOSAT system's potential, we believe it will be adopted as an important new element in the treatment of patients with cancers in the liver."

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. 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.

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: the benefits of the new hemofiltration cartridge for the CHEMOSAT system and market acceptance of the same, patient outcomes using the new hemofiltration cartridge, the timing of the supply and distribution of the CHEMOSAT system including the new hemofiltration cartridge to early launch centers 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, 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.

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SOURCE Delcath Systems, Inc.

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