DCTH: This PR sums up

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joey68
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DCTH: This PR sums up DCTH:

http://delcath.com/reuters-news/?id=2262473

1. DCTH's product has been in use for years in Europe and is doing well:

The product is commercially available in Europe under the trade name CHEMOSAT, and is being evaluated as an investigational therapy in the U.S. Delcath is currently enrolling patients in the FOCUS trial, a global Phase 3 clinical trial that is investigating PHP with Melphalan/HDS as a treatment for patients with ocular melanoma that has metastasized to the liver.

2. This is what it does:

PHP is a minimally invasive procedure that isolates the liver from the body’s circulatory system, so that a high dose of chemotherapy (melphalan hydrochloride) may be infused directly into the liver with the potential to treat both visualized and non-visualized metastases. Blood from the liver is then filtered to remove the chemotherapeutic agent thereby minimizing systemic exposure and potentially the associated side effects.

3. It works:

In the case of Mr. Carney, he was referred to Spire Southampton, and received his first PHP treatment in December 2013. In the intervening period, he has also undergone liver resections and immunotherapy treatments. He recently became the first patient in the world to receive eight PHP treatments, which controlled the tumor and allowed him to conduct normal daily activities at his home.

4. Phase 3 trial in effect for USA:

We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver.
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