Adriamycin is awaiting human tests

Celsion asks FDA to clear prostate cancer treatment

April 09, 2002|By Julie Bell | Julie Bell,SUN STAFF

Celsion Corp. said yesterday that it had applied to the Food and Drug Administration to begin human testing of a new prostate-cancer treatment.

If the treatment is cleared for testing by the FDA, up to 30 patients will get infusions of a chemotherapy drug enclosed in tiny fat vesicles known as liposomes. The heat-activated liposomes are designed to accumulate in the prostate tumor, then quickly dump their therapeutic contents - the drug Adriamycin - when targeted by a Celsion focused-heat system.

The Phase I clinical trial, designed primarily to test the safety of the therapy, is scheduled to take place at Roswell Park Cancer Institute in Buffalo, N.Y. All patients in the trial subsequently will have prostate surgery, allowing their tumors to be examined afterward to determine if the therapy killed the cancer, said Celsion Chief Executive Officer Augustine Cheung. The examination will provide an early indication of the treatment's promise.

"We plan additional trials targeting not only prostrate, but also liver, ovarian, breast and other cancers," Dr. Bill Gannon, Celsion's medical director, said in a statement.

Celsion already has completed a Phase II trial of its focused-heat treatment for enlarged prostates and is in the process of submitting results to the FDA. Its clinical trial testing focused heat treatment against breast tumors is ongoing.

Columbia-based Celsion has about $4.5 million in cash, Cheung said. He said the company likely will have to raise money to complete the liposome and breast-treatment trials.

Shares of Celsion rose 1 cent yesterday to 64 cents on the American Stock Exchange.

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