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Delcath Shows Positive Data Chemosat Delivery System.

M2 PHARMA-May 29, 2015-Delcath Shows Positive Data Chemosat Delivery System

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The results of a large, European single-center experience of the treatment of uveal melanoma patients with hepatic metastases with the US-based specialty pharmaceutical and medical device company Delcath Systems, Inc.'s (NASDAQ: DCTH) Delcath Hepatic Chemosat Delivery System were highlighted in an on-line abstract at the American Society of Clinical Oncology annual meeting 2015, the company said on Friday.

Uveal melanoma, also known as ocular melanoma, is a rare cancer of the eye with a very poor prognosis. According to the study authors, "50% of patients develop distant disease, mainly in the liver, with a mean survival of six months and one-year survival rate of 15-20%."

In this study, 20 patients received 34 treatments with Chemosat (1-3 treatments per patient). Radiologically, 2 patients demonstrated stable disease for >3 months, 13 patients had a partial response in the liver with complete responses in 2 patients. Nine deaths from disease progression occurred after a median of 264 days from the first procedure.

Eleven patients remain alive after a median of 280 days with one complete response ongoing at >1 year. From the diagnosis of liver metastases, 11 patients have survived to one year and 3 for >2 years. No procedure related deaths were seen.

Adverse events seen were grade 1, 2, 3 and 4.

The grade 4 complication was pulmonary edema due to fluid overload. Early AEs often expected with percutaneous hepatic perfusion were observed including coagulopathy, electrolyte disturbances and transient transaminases (elevated liver enzymes).

Rare late AEs (1 patient each) included hair loss, skin rash, myelosuppression and persistent transaminases (elevated liver enzymes).

Chemosat is a CE Marked approved product in Europe and is not approved in the United States.

According to the National Cancer Institute, ocular (uveal) melanoma is a rare cancer that forms from cells that make melanin in the iris, ciliary body, and choroid.

It is the most common eye cancer in adults, affecting one in every 5m people in the US, with comparable incident rates in Europe.

Delcath Systems is a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers.

Its proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure.

In April 2012 we obtained authorization to affix a CE Mark to its second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic Chemosat Delivery System for Melphalan.

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Publication:M2 Pharma
Date:May 29, 2015
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