VIRAL VECTOR STABILIZATION
Combining viral vector with surfactant preserves vector infectivity, and surfactant provided an unexpected benefit by protecting viral vector from damage due to transient elevated temperature.
1 - 40 . (canceled)
41 . A method of treating bladder cancer in a human, the method comprising: intravesical administration of an admixture to the human,
wherein the admixture comprises an infective recombinant adenovirus gene transfer vector and a surfactant in an amount to preserve infectivity of the recombinant adenovirus,
wherein the infective recombinant adenovirus gene transfer vector comprises a transgene,
wherein infectivity of the recombinant adenovirus is preserved during intravesical administration, and
wherein the surfactant has Structure I:
42 . The method of claim 41 , wherein the admixture is stable as determined viral particle concentration and size using HPLC.
43 . The method of claim 41 , wherein the admixture is stable as determined by a particle size assay.
44 . The method of claim 41 , wherein the admixture is stable as determined by an infective titer.
45 . The method of claim 41 , wherein the admixture is stable as determined by a potency assay.
46 . The method of claim 41 , wherein the admixture is stable as determined by pH.
47 . The method of claim 41 , wherein the infective recombinant adenovirus gene transfer vector is rAd-IFN.
48 . The method of claim 41 , wherein gene transfer into the human's bladder epithelium is enhanced.
48 . The method of claim 41 , wherein the admixture comprises 3×10 11 vp/ml of rAd-IFN.
49 . The method of claim 41 , wherein the admixture comprises 1 mg/ml of the surfactant.
50 . The method of claim 41 , wherein the admixture has been stored at room temperature and/or 4° C. prior to administration.