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Delcath Systems (DCTH) Granted Orphan-Drug Status For Doxorubicin

August 31, 2009 6:41 AM EDT
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Delcath Systems, Inc. (Nasdaq: DCTH) announced that the FDA granted Delcath's request for orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Clinicians in the U.S. diagnose nearly 20,000 cases of HCC annually.

Doxorubicin is a common chemotherapy agent shown to be effective for the treatment of HCC, as well as hematological malignancies, soft tissue sarcomas, and many types of carcinoma. Delcath Systems performed early clinical studies of doxorubicin with its Percutaneous Hepatic Perfusion (PHP(TM)) technology, which allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug, with very encouraging results. The company plans to perform the clinical work necessary for a submission to the FDA of PHP(TM) with doxorubicin for treatment of HCC.

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