Jack A. Roth of the M.D. Anderson Cancer Center in Houston onWednesday requested FDA approval of human trials for anantisense gene therapy treatment.
This would be the first in vivo antisense clinical trial, JordanU. Gutterman, chairman of the department of clinicalimmunology and biological therapy at M.D. Anderson toldBioworld.
The Recombinant DNA Advisory Committee on Tuesday grantedpermission for the treatment involving 14 patients sufferingfrom non-small cell carcinoma of the lung, a disease oftencaused by smoking.
Roth reported in the March 15, 1991, issue of Cancer Researchthat human lung cancer cells containing an antisense K-rasoncogene grew more slowly than untreated cancer cells.Insertion of the antisense gene in mice also reduced the abilityof malignant lung cells to form tumors.
The antisense gene also inhibited expression of the K-rasoncogene but did not affect the expression of normal genes,suggesting that the technology may target the cellular defectsleading to cancer without killing the cell itself.
A gene sequence of the Kras oncogene that is a mirror image ofthe cell's copy of the K-ras gene will be linked to a harmlessvirus, which will be used as the delivery vehicle. The viralpackage, which will be injected into patients' lungs, shouldinfect only rapidly dividing cancerous cells. Patients willreceive five such gene therapy injections.
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