Therion Biologics Corp. has started a Phase I/II trial with thefirst therapeutic cancer vaccine in U.S. clinical trials that bearsthe gene for carcinoembryonic antigen (CEA).

The live virus vaccine is based on a poxvirus engineered tocontain the gene for the human CEA protein, which is on thesurface of many types of cancer cells.

Called TBC-CEA, the protein is being developed in collaborationwith the National Cancer Institute (NCI).

"The rationale for this approach, which uses vaccinia and atumor antigen to elicit a full range of immune responsesagainst cancer cells, is supported by results obtained frompreclinical tests conducted by Therion and NCI," said DennisPanicali, president and chief executive officer of the Cambridge,Mass., company.

Approximately 50 patients with CEA-bearing tumors of thegastrointestinal tract, breast or lung will participate in the trial,receiving a vaccination once a month for three months.

The NCI developed a recombinant vaccinia virus expressinghuman CEA as a prototype of the cancer vaccine now in clinicaltrials. NCI researchers reported in the July 15, 1992, issue ofthe Journal of the National Cancer Institute that colon tumors inmice vaccinated with the prototype slowed in growth orregressed, and the mice exhibited both antibody and cell-mediated responses. -- Nancy Garcia

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