Applied Immune Sciences Inc. has begun enrolling 160 patients withmetastasized kidney cancer in multicenter Phase III trials designed totest an ex vivo cell therapy in which CD8+ tumor infiltratinglymphocytes (TIL) are isolated, activated with interleukin-2 (IL-2)and increased in number before being re-infused.

In Phase I/II trials of the therapy, which uses Applied ImmuneSciences' AIS CELLector-CD8 device to isolate the patients'targeted immune system cells, 44 percent of the 16 advanced kidneycancer patients experienced a 50 percent or more reduction in tumorsize. In two patients, tumors were eliminated. Typically, only 15percent of advanced kidney cancer patients respond to currentlyavailable chemotherapies.

Jackie Cossmon, spokeswoman for Santa Clara, Calif.-based AppliedImmune Sciences, said the Phase III trials, expected to take twoyears to complete, will be held at 14 medical centers in the U.S. Thetrials will evaluate the company's cell therapy in combination withIL-2 against use of IL-2 alone.

The trials represent Applied Immune Sciences most advancedclinical studies with its AIS CELLector-CD8 device.

The treatment process, Cossmon said, first involves removing apatient's kidney and extracting the tumors. The tumors then are sentto the ExVT Cell Processing Center in Torrence, Calif., which isoperated as a 50-50 joint venture with Rhone-Poulenc Rorer, ofCollegeville, Pa. Rhone-Poulenc Rorer, a subsidiary of the France-based Rhone-Poulenc Group, owns 37 percent of Applied ImmuneSciences.

At the cell processing center, the AIS CELLector device isolatesCD8+ TIL cells and they are activated with IL-2 and multiplied innumber before they are sent back to the physicians for re-infusion inthe patients.

The ex vivo cell therapy takes about four to six weeks to complete.Once the activated CD8+ TIL cells are back in the patient, the theoryis they will kill the metastasized cancer.

Applied Immune Sciences said its cell processing differs from othertypes of ex vivo cell therapy in that it expands the number ofactivated immune cells before they are put back in the patients. n

-- Charles Craig

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