In the U.S., 20,000 cases of hepatocellular carcinoma (HCC), also known as primary liver cancer are diagnosed annually. Delcath delivered doxorubicin, a common chemotherapy agent shown to be effective for the treatment of HCC, with the help of Percutaneous Hepatic Perfusion (PHP) technology that delivers significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug.
The company still has to perform more clinical studies before submission to the FDA of PHP with doxorubicin for treatment of HCC. But the orphan drug status is encouraging, as the company could now receive clinical study invcentives, potential tax credits and other aid, and be assured its efforts and current cash outlays, once the drug is approved, would be protected to a longer -- up to seven years marketing exclusivity -- under the act.
"Following our orphan-drug designations for several applications of melphalan, this new designation for doxorubicin is an important step towards securing our leadership position in the regional treatment of liver cancers," said Eamonn Hobbs, President and CEO of Delcath Systems.
While earlier studies were successful, according to the company, nothing is in the bag yet. Investors and patients alike would like to see this work, as such a delivery system could make treatments more tolerable and effective.
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