RCT TISSUE-SPECIFIC HUMAN GENE PROMOTER PATENTED IN EUROPE.

The European Patent Office has granted Patent No. 0625206 to Research Corporation Technologies, Tucson, Ariz., for a human gene promoter that enables tissue-specific expression of foreign genes in epidermal cells.

The DNA promoter sequence from the human epidermal type 1 transglutaminase (TGase I) gene can be employed for gene expression, gene therapy, DNA vaccines and in vitro skin-sensitivity testing. This technology is also protected by U.S. Patent No. 5,643,746. Another patent application is pending in Japan.

The TGase I promoter is available through RCT's Gene Expression Technologies (GET) licensing program, which offers systems and components for gene expression at affordable costs. The GET program offers flexible, nonexclusive licenses with manageable fees and fractional royalties based on fields of use. Renata W. Polakowska, Ph.D., and Lowell Goldsmith, M.D., isolated, cloned and characterized the promoter at the University of Rochester School of Medicine.

To express and function properly, a gene must be controlled by a segment of DNA called a promoter. While promoters vary in size and function, their role in controlling gene expression is constant. The TGase I gene promoter is regulated by several environmental factors of which calcium and retinoic acid appear to be most useful. Incorporating the TGase I promoter into vectors could be particularly useful for human gene therapy, vaccines, drug delivery, artificial skin production, and testing pharmaceuticals and cosmetics. Other uses might include controlling foreign gene expression in transgenic animals.

The potential market for tissue-specific human gene promoters is extensive. Most vectors constructed for human gene therapy use promoters derived from viruses; Polakowska and Goldsmith's promoter is from a human source. Along with tissue specificity, the promoter provides differential regulation under physiological conditions or when factors such as calcium and retinoic acid are added.

A second market for this promoter is the field of artificial skin development. Controlling gene expression in skin-graft cells could lead to production of immunosuppressive agents to reduce host rejection, enhanced water retention by altering membrane composition, and provide expression of antibacterial peptides and proteins to prevent infection.

A third application is testing of cosmetics, fragrances, toiletries and pharmaceuticals. Employed with appropriate reporter genes, this promoter could provide a rapid assay for in vitro testing of chemicals and compositions. The increased credibility for in vitro testing that this promoter may provide could reduce chemical testing on animals.

The uses for this promoter region extend beyond controlled gene expression in skin cells. Certain types of epithelial cells with embryonic origins similar to skin may prove to be additional sites for gene control. Epithelial cells from esophagus, vagina, oral pharynx, mouth, upper respiratory tract or amnion could be ideal targets for this promoter.

For more information, call 520/748-4400.