View printer-friendly version

(Thomson Reuters ONE via COMTEX) --EU Physicians Agree System's Ability to Treat Whole Organ with High Dose Chemotherapy

is Valuable to Help Manage Patients with Life-threatening Cancers in the Liver

LISBON, Portugal, Sept. 19, 2012 - Delcath Systems, Inc. (NASDAQ: DCTH) announced today that physicians from Italy and Germany shared their experiences with its Generation Two Hepatic CHEMOSAT® Delivery System in treating patients with cancers in the liver as part of a satellite symposium at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. Discussion at the meeting centered on the ability of CHEMOSAT to deliver high dose chemotherapy directly to the liver to help control cancer in this vital organ, and potentially allow additional time to treat disease outside the liver that is not imminently life threatening.

Key presenters at the symposium-Hepatic Chemosaturation Therapy: Expanding the Therapeutic Approaches of Interventional Radiology-included Franco Orsi, MD, PhD, and Pier Francesco Ferrucci, MD, both from the European Institute of Oncology, Milan, Italy, and Thomas J. Vogl, MD, from Johann Wolfgang Goethe-Universitat, Frankfurt, Germany. The physicians expressed their opinions on the advantages of CHEMOSAT and presented case studies on patients who have been treated with the technology.

"With CHEMOSAT, we are able to isolate and directly treat the whole organ, which allows us to address both the visible tumors, as well as the micro-metastases, with higher dosing designed to improve tumor-killing efficacy," Dr. Ferrucci said. "Based on our experience thus far, this treatment approach may expand the window of opportunity to treat the primary or metastatic disease in the liver."

Historically, control of cancers in the liver can be challenging because traditional procedures, such as surgery, radiofrequency ablation and cryotherapy, treat visible tumor sites, but tumors too small to be seen go untreated. Systemic chemotherapy, in which anti-cancer drugs are administered through a vein or given by mouth, spreads throughout the entire body. Because the drug dose in systemic chemotherapy is limited by systemic toxicity, the amount of drug reaching the liver is lower than can be administered with CHEMOSAT. For this reason, CHEMOSAT could potentially achieve efficacy for cancers in the liver that conventional chemotherapy cannot.

Discussion during the symposium focused on potential side effects and the range of cancer types that can be treated using the technology. The panel noted that the typical side effects from a CHEMOSAT procedure are predictable and manageable by medical oncologists / hematologists. The physicians also noted that studies utilizing chemosaturation have shown potential for a range of cancer types using melphalan.

"This symposium led to a lively and engaged discussion, and demonstrated the level of interest among European physicians in finding new ways to manage patients with cancers pre-dominantly confined in liver," said symposium moderator Barry T. Katzen, MD, FACR, FACC, FSIR at Baptist Cardiac and Vascular Institute, Miami, Florida. "It was clear that interventional radiologists see CHEMOSAT as an important treatment modality for them to participate in the management of these patients."

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 2 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 filed a New Drug Application (NDA) for its proprietary chemosaturation system with the second-generation hemofiltration cartridge in August 2012 seeking FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at

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: acceptance of the Company's new drug application (NDA) including the Generation 2 filter, the FDA's granting of our request for priority review, the timing of a PDUFA date, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from 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, 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 training for 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 cancers in the liver, 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, acceptance of our IND amendment, 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.

Contact Information:
Investor Contact:         Media Contact:
Doug Sherk/Gregory Gin    Janine McCargo
EVC Group                 EVC Group
415-568-4887/646-445-4801 646-688-0425

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the

information contained therein.

Source: Delcath Systems, Inc via Thomson Reuters ONE