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WIKI ANALYSIS
Delcath Systems (NASDAQ: DCTH) is a medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath's Percutaneous Hepatic Perfusion (PHPTM) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient's entire body to the anti-cancer drugs.
On 8/31/09, Delcath announced that the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.
On 8/25/09, DCTH reported that it has exceeded 90% enrollment for its pivotal Phase 3 Metastatic Melanoma Trial which will enroll a total of 92 patients. This study is testing the PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic melanoma (a deadly type of skin cancer) who have tumors in the liver, which cannot be removed by surgery (unresectable). On 10/21/09, DCTH announced that its pivotal Phase 3 Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled. With the achievement of complete enrollment, the company remains on-track for a FDA submission of its Delcath PHP System with melphalan by mid-2010 based on previous guidance.
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