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Post-Hoc Analysis of Delcath Systems, Inc. (DCTH)'s Phase 3 Trial Presented at American Society of Clinical Oncology



6/6/2012 10:36:21 AM

NEW YORK and CHICAGO, June 5, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ-DCTH) announced that an exploratory analysis of the Company's Phase 3 trial was presented at the American Society of Clinical Oncology (ASCO) held in Chicago, IL this week. The poster Percutaneous Hepatic Perfusion (PHP) with Melphalan in Patients with Unresectable Liver Metastases from Melanoma: A Post-Hoc Analysis of PHP Randomized vs. Best Alternative Care (BAC)-to-PHP Crossover vs. BAC Only Patientswas presented by Dr. Richard Alexander, Associate Chairman for Clinical Research and Surgery at the University of Maryland Medical Center, on behalf of the Company's Phase 3 trial investigators.

The exploratory analysis compared patients assigned to BAC who crossed over to PHP after disease progression (BAC-to-PHP crossover) with those who did not (BAC-only) and with those randomized to PHP-melphalan (chemosaturation therapy). The analysis found that as measured by the trial's primary endpoint of hepatic progression free survival (hPFS), the BAC-cross over arm of the study was consistent with the hPFS achieved in patients randomized directly to the chemosaturation arm. Furthermore, the study showed that crossover from BAC to the chemosaturation arm led to a median overall survival benefit of 11 months compared to treatment with BAC alone. The safety profile of chemosaturation in patients that crossed-over from BAC and patients randomized directly to chemosaturation was similar. Dr. Alexander concluded that chemosaturation is a new treatment option for unresectable metastatic melanoma in the liver.

"Dr. Alexander's conclusion from this analysis echoes the remarks made by our experts during Friday's analyst meeting, that chemosaturation therapy has the potential to play an important role in disease control in the liver," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "Interest in chemosaturation therapy has been high during ASCO, and we expect to see an increasing number of patients being treated in Europe as the year progresses," added Mr. Hobbs. "We are also very pleased that the first European commercial center for CHEMOSAT, the European Institute of Oncology, reported during our analyst meeting that the second treatment performed with our Generation 2 CHEMOSAT® system achieved a reduction in side-effects consistent with the first treatment. The members of our panel stated that, in their opinion, if this performance continues to be validated in clinical practice, it is an important new dimension in the development of this new therapy for cancers in the liver."

Delcath Sponsored Analyst Symposium Highlights Broad Potential

On Friday, June 1, Delcath hosted an analyst day symposium where an internationally recognized panel of experts on innovative treatments for patients with cancers of the liver discussed the impact of Delcath's chemosaturation therapy on the treatment paradigm for cancers in the liver. The Delcath sponsored panel included Dr. Alexander; Fred Moeslein, MD, PhD, an Interventional Radiologist and Interim Director, Interventional Neuroradiology, University of Maryland Medical Center; Alessandro Testori, MD, a Surgical Oncologist and Director, Division of Melanoma and Skin-Muscle Sarcoma, European Institute of Oncology; Pier Francesco Ferrucci, MD, a Medical Oncologist and Director, Translational Research on Melanoma Unit, European Institute of Oncology; and Steven O'Day, MD, an Oncologist and Director, The Los Angeles Skin Cancer Institute; Director, Clinical Research, the Beverly Hills Cancer Center and Clinical Associate Professor of Medicine, University of Southern California Keck School of Medicine. The panel stated that chemosaturation has the potential to be a broadly adopted new treatment option for cancers in the liver, including a possible bridging role for chemosaturation therapy to the new immunologic cancer therapies.

An archive of the presentations by the panel of experts is available at http://www.delcath.com/investors/events/past-events

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: 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, 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.

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Media Contact:

Doug Sherk/Gregory Gin

Janine McCargo

EVC Group

EVC Group

415-568-4887/646-445-4801

646-688-0425

SOURCE Delcath Systems, Inc.


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