NEW YORK, Feb. 15, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) and the European Institute of Oncology (Instituto Europeo di Oncologia – IEO) introduced the Delcath Hepatic CHEMOSAT® Delivery System to media at a Feb. 15 press conference and discussed the status of the first European patients treated with the technology. CHEMOSAT is a critical new treatment option for patients who suffer from inoperable liver-dominant metastases.
During the press conference, the IEO, a premier European cancer treatment and research center located in Milan, also inaugurated a specialized task force for melanoma diagnosis and skin cancer treatment, underscoring their commitment to broadening availability of treatment options in Europe.
The IEO initiated CHEMOSAT treatments on January 31, 2012, and has thus far treated three patients— two with liver metastasis stemming from ocular melanoma and one from gastric cancer. Patients responded well to treatment, and after observation physicians reported that their condition is good and expected to improve in the coming weeks.
"CHEMOSAT is a unique option for those suffering from cancers in the liver, which have significantly lower survival rates when compared to other cancers," said Dr. Alessandro Testori, a surgical oncologist and director of the Division of Melanoma and Skin-Muscle Sarcoma. "The IEO is pleased to be the first center in Europe to perform these procedures in an institutional setting. For the first time, patients now have access to a new technology which will ultimately create options for those in need."
Dr. Umberto Veronesi, Scientific Director at the IEO and speaker at the press conference, also discussed the importance of CHEMOSAT and its potential reach across Europe. Other physicians and members of the specialized task force, including Dr. Franco Orsi, Dr. Pier Francesco Ferrucci, Dr. Luisa Lanfrancone, Dr. Maria Rescigno, Dr. Giuseppe Spadola and Dr. Giulio Tosti, participated in the historic press conference.
"The preliminary results from these procedures reaffirm our confidence of CHEMOSAT's ability to help patients suffering from cancers in the liver," said Eamonn P. Hobbs, president and CEO of Delcath. "We are delighted with the status of our partnership with the IEO, a prestigious leader in cancer treatment. Furthermore, we are extremely encouraged by the IEO's support in helping to advance the progress of CHEMOSAT treatment in Europe."
About the IEOThe European Institute of Oncology was established in 1994 to implement an innovative model for health and advanced research in the international oncology field. The IEO's mission is focused on state-of-the-art cancer research and treatment, from basic laboratory research that grapples with the genetic roots of cancer, to advanced clinical research such as testing new drugs, all with the unifying goal of finding ways to treat patients more effectively.
About Delcath SystemsDelcath Systems, Inc. is a development stage 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 concluded a Phase III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at http://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 future use and adoption of the CHEMOSAT system by the European Institute of Oncology, uncertainties relating to future initial launch and training agreements with other cancer centers in Europe, CE Marking for the Generation Two system and the timing of our commercial launch 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, 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.
Only the English version of this press release is legally valid. The versions in other languages only represent a translation of the original English version.Contact Information: U.S. Investor Contact:
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EU Media Contact:Doug Sherk/Gregory Gin
Julie A. JohnsonEVC Group
|SOURCE Delcath Systems, Inc.|
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