Transgene, a French biotech company, announced Thursdaythat the French Genetic Engineering Commission has approvedits gene therapy protocol for treating cystic fibrosis.
Other regulatory bodies, including the French Drug Agency,must approve the protocol before the trials actually begin.
The protocol involves delivering the normal CF gene (CFtransmembrane conductance regulator gene) via aerosol to thelungs of several patients over the age of 18.
Transgene researchers, together with Michel Perricaudet of theCentre National de la Recherche Scientifique, developed theadenovirus vector for delivering the CF gene that will be usedin the French trials.
Gene therapy trials for CF in the U.S. actually got under waylast Saturday, when Ron Crystal of New York Hospital-CornellMedical Center treated a young adult CF patient with a solutionof the CF gene-containing adenovirus vector dripped into thenose and later delivered to the lungs via bronchoscope.
Crystal, a gene therapy pioneer and an 18-year veteran of theNational Heart, Lung and Blood Institute of the NationalInstitutes of Health, recently co-founded a new biotechcompany, GenVec, which has a research collaboration withGenentech Inc. Crystal was one of the first investigators toreceive approval last December from the NIH's recombinantDNA advisory committee (RAC) for the CF gene therapy trials.
Genzyme Corp. (NASDAQ:GENZ) of Cambridge, Mass., also hasRAC approval for human trials of its CFTR gene-adenovirusvector, as does Genetic Therapy Inc. of Gaithersburg, Md., aswell as University of Pennsylvania researcher James Wilson. --Jennifer Van Brunt
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