Cel-Sci Corp. is preparing to take Multikine back into the clinic aftera delay of more than three years attributable to manufacturing issues.

The Alexandria, Va., company said Monday it received clearance inCanada to start a Phase I/II study of its cytokine mixture in up to 30refractory head and neck cancer patients. Cel-Sci CEO Geert Kerstensaid the first patients are expected to be treated late this summer.

More than three years ago Multikine was in small studies assessingdosing and safety factors. "The earlier studies showed there wasenough promise to warrant a major expense in terms ofmanufacturing," Kersten told BioWorld. "In the past few years we'vespent a lot of time and money in manufacturing Multikine."

The product contains interleukin-2 and other cytokines filtered fromhuman blood that was stimulated to express the various cytokines.Preclinical studies showed the drug induced killer T cell and naturalkiller cell responses.

"This is the most important milestone we've reached in a long time,"Kersten said of the investigational new drug (IND) applicationapproval. "Our goal is to show that immunotherapy might have aplace in the treatment of head and neck cancer patients. If you canreduce the tumor burden, build up the immune system and improvethe quality of life, you've come a long way."

The drug will be injected subcutaneously 10 days each month on anoutpatient basis. The length of treatment will depend on eachpatient's response.

Cel-Sci filed an IND with the FDA last August. Kersten said talks areongoing with the agency.

Cel-Sci's stock (NASDAQ:CELI) closed at 75 cents per shareMonday, up 19 cents, or 34 percent. _ Jim Shrine

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