Human urothelial cell specific uroplakin transcriptional regulatory sequences, vectors comprising uroplakin-specific transcriptional regulatory sequences, and methods of use thereof

An isolated polynucleotide comprising 200 contiguous nucleotides of SEQ ID NO:

• 1, wherein the polynucleotide exhibits urothelial cell specific TRE activity.

An isolated polynucleotide which hybridizes under stringent conditions to 200 contiguous nucleotides of SEQ ID NO:

• 1 wherein the polynucleotide exhibits urothelial cell-specific TRE activity.

An isolated polynucleotide having at least about 70% sequence identity to 200 contiguous nucleotides of SEQ ID NO:

• 1, wherein the polynucleotide exhibits urothelial cell-specific TRE activity.

A method for screening for compounds which alter expression of a urothelial cell-specific gene, said method employing cells containing an expression construct, said expression construct comprising an hUPII TRE and a marker gene whose expression provides a detectable signal, wherein said marker gene is under the transcriptional control of the hUPIITRE, and the cell allows function of the hUPII TRE, said method comprising (a) combining the cells with a candidate compound and incubating the cells for a sufficient time for detectable expression of the marker gene and (b) detecting the level of expression of the marker gene as compared to the level of expression in the absence of the compound, wherein an alteration of expression in the presence of the compound indicates that the compound alters urothelial cell-specific expression.

An adenovirus vector comprising a gene under transcriptional control of a urothelial cell-specific transcriptional response element (TRE).

An adenovirus vector comprising

• (a) an adenovirus gene under transcriptional control of a urothelial cell-specific transcriptional regulatory element (TRE);
• and
• (b) an E3 region.

A replication-competent adenovirus vector comprising co-transcribed first and second genes under transcriptional control of a urothelial cell-specific (TRE), wherein the second gene is under translational control of an internal ribosome entry site (IRES).