GenVec Inc. said Tuesday its proposed gene therapy trial for cysticfibrosis patients was endorsed by the National Institutes of HealthRecombinant DNA Advisory Committee (RAC). The Rockville, Md.,company still is waiting for FDA approval before beginning a PhaseI/II trial.The protocol, which will involve 26 patients, will test repeatedadministration of the adenovirus-based vector at 30-day intervals. TheGenVec vector will be delivered directly to the epithelial surfaces ofthe large airways in patients' lungs.Treatment efficacy will be determined by the vectors' ability to correctbetween 5 and 10 percent of the epithelial cells, the minimum neededto be effective in treating cystic fibrosis, said Thomas D'Alonzo,GenVec's president and CEO. Success will be measured throughexpression of the corrected cystic fibrosis gene and chloride secretion,he said. _ Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.