UPDATE 1-Delcath's chemotherapy agent gets orphan drug status

* Co to perform clinical work for regulatory submission

* Shares up 48 pct in premarket trade

Aug 31 (Reuters) - Delcath Systems Inc (DCTH.O) said U.S. health regulators granted an orphan drug status to doxorubicin, a chemotherapy agent, for the treatment of primary liver cancer, sending its shares up 48 percent.

The company said it tested doxorubicin with its 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.

Delcath, which has performed some early studies, plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.

The U.S. Food and Drug Administration's orphan drug designation is reserved for new therapies that are being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States and grants the drug developers seven years of market exclusivity.

Delcath said that nearly 20,000 cases of hepatocellular carcinoma, or primary liver cancer, are diagnosed in the United States annually.

Shares of the company were up 48 percent to $4.50 in premarket trade from their Friday's close of $3.04 on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan)