Delcath Systems (DCTH) Announces Presentation of Positive CHEMOSAT Data at CIRSE Meeting

September 14, 2016 8:31 AM EDT

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Delcath Systems, Inc. (Nasdaq: DCTH announces that results from two single-institution studies conducted in Germany of use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with liver metastases were presented as posters at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting.

The first study, Secondary Resectability of Ocular Melanoma Liver Metastases (OMLM) Following Percutaneous Hepatic Perfusion (PFP) by M. Zeile, et al. of the Asklepios Barmbek Clinic in Hamburg, Germany, evaluated 7 patients with unresectable ocular melanoma liver metastases treated with CHEMOSAT. There were 12 CHEMOSAT procedures administered in total, with a median of 2 cycles per patient, and a range of 1 to 3. The objective response rate after 1-2 treatments was 71.4%. Two patients showed secondary resectability on imaging after completing two treatments and remain alive for over 26 months following resections. Progression free survival was 9.9 months and hepatic progression free survival was 11.2 months. Median survival for the study has not yet been reached, but is higher than 16.9 months. There were no adverse events of grade 3 or higher. Investigators concluded that CHEMOSAT is safe to use in these patients and that significant downsizing of ocular melanoma liver metastases can be achieved with CHEMOSAT. These researchers concluded that if these promising results were further validated it “may lead to a new standard of therapy for the treatment of patients with ocular melanoma liver metastases.”

The second study, Percutaneous Isolated Hepatic Perfusion (Chemosaturation) In Patients With Primary Or Secondary Liver Tumours: Experience In 20 Patients, by S. Marquardt et al., of Hanover Medical School in Hanover, Germany, retrospectively evaluated patients with advanced disease from primary or metastatic cancers of the liver. The local response rate (stable disease or partial response) was 80%. Mean progression free survival was 3.2 months. The investigators reported no major complications and that bone marrow suppression was common but controllable. The investigators concluded that patients with primary or secondary liver tumors that have disease progression under standard therapy “may profit from PHP with Melphalan,” that technical execution is problem-free, and complications are manageable.

We are very pleased with the results of these studies, which both show noteworthy results achieved with CHEMOSAT in difficult to treat patients with few effective options,” said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. “These single-institution studies add to the growing body of research that support a significant role for CHEMOSAT in the management of patients with cancers of the liver.”

The CIRSE conference is being held in Barcelona, Spain at the Centre de Convencions Internacional de Barcelona from September 10-14, 2016. Additional information for the CIRSE Scientific Program is available here.



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