Vical Inc. has begun a Phase I/II trial in Canada of its gene therapyproduct for malignant melanoma, marking the first gene therapyprotocol to be undertaken in Canada, the San Diego company said.
The trial, which will enroll 15 patients, will be conducted at theBritish Columbia Cancer Agency in Vancouver, British Columbia.The product, Allovectin-7, already is being tested in four Phase I/IItrials in the U.S.
Allovectin also is being studied for melanoma in trials at the ArizonaCancer Center in Tucson and in an investigator-sponsored trial at theUniversity of Michigan. The Arizona trial involves different dosingand dosing regimens, while those in the Canadian trial all will begiven six injections over several months, Robert Zaugg, Vical's vicepresident for business development, told BioWorld.
He said the trial in Canada will assess the safety and tolerability ofthe product. The company also will be looking to see whether thegene product is being expressed and inducing an immune response,as well as whether there are any sings of tumor regression.
Two other trials of Allovectin-7 are ongoing in renal cell carcinomaand colorectal carcinoma.
The product contains a gene that encodes a foreign tissue antigenwhich, when injected into tumors, causes the malignant cells to bearthe foreign antigen on their surface. The company believes thepatient's immune system, which had failed to recognize the tumorcells as aberrant, may now attack and destroy them as if they wereforeign tissue. _ Jim Shrine
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