High capacity recombinant adenoviral vector for treatment of...

Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Genetically modified micro-organism – cell – or virus

Reexamination Certificate

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C435S320100, C435S456000, C514S04400A

Reexamination Certificate

active

10191760

ABSTRACT:
The invention relates to adenoviral vectors. More particularly, this invention relates to recombinant high capacity adenoviral vectors which can be employed in the treatment of hemophilia A, as well as methods and process for their creation and use.

REFERENCES:
patent: WO 97/45550 (1997-12-01), None
Connelly et al., “Complete short-term correction of canine hemophilia A by in vivo gene therapy,” Blood 88 (10): 3846-3853, 1996.
Reddy et al., “Sustained human factor VIII expression in hemophilia A mice following systemic delivery of a gutless adenoviral vector,” Mol. Ther. 5 (1): 63-73, Jan. 2002.
Gallo-Penn et al., “Systemic delivery of an adenoviral vecotr encoding canine factor VIII results in short-term phenotypic correction, inhibitor development and biphasic liver toxicity in hemophilia A dogs,” Blood 97 (1): 107-113, Jan. 1, 2001.
Balague et al., “Sustained high-level expression of full-length human factor VIII and resoration of clotting activity in hemophiliac mice using a minimal adenovirus vector,” Blood 95: 820-828, 2000.
Brown et al., “Helper-dependent adenovirus delivery of a canine FVIII B-domain deleted transgene in murine and canine models of hemophilia A,” Blood 98 (11, pt. 1): 695a-696a, Nov. 16, 2001.
VandenDriessche et al., “Viral vector-mediated gene therapy for hemophilia,” Curr. Gene Ther. 1 (3): 301-315, Sep. 2001.
Brown et al., “Helper-dependent adenoviral vectors mediate therapeutic factor VIII expression for several months with minimal accompanying toxicity in a canine model for sever hemophilia A,” Blood 103 (3): 804-810, Feb. 1, 2004.
Chuah et al., Therapeutic factor VIII levels and negligible toxicity in mouse and dog models of hemophilia A following gene therapy with high-capacity adenoviral vectors, Blood, Mar. 1, 2003, pp. 1734-1743, vol. 101, No. 5.
Linthout et al., Effect of Promoters and Enhancers on Expression, Transgene DNA Persistence, Hepatotoxicity After Adenoviral Gene Transfer the Human Apolipoprotein A-I, Human Gene Therapy, May 1, 2002, pp. 829-840, vol. 13.
VandenDricsche et al., Gene therapy for hemophilia A using onco-retroviral, lentiviral and gutless adenoviral vectors, Abstract, 9th Meeting of the European Society of Gene Therapy, Nov. 2-4, 2001, Antalya, Turkey, cover page, p. 3 and p. 26.
Presentation, Adenoviral Vectors, presented Nov. 2, 2001.
Brown et al., Helper-dependent adenovirus delivery of a canine FVIII B-domain deleted transgene in murine and canine models of hemophilia A, Abstract, Blood, Nov. 16, 2001, pp. 695a-696a, vol. 98, No. 11.
Brown et al., Helper-dependent adenoviral vectors mediate therapeutic factor VIII expression for several months with minimal accompanying toxicity in a canine model of severe hemophilia A, Blood, Feb. 1, 2004, pp. 804-810, vol. 103, No. 3.
Chuah et al., Biosafety of Adenoviral Vectors, Current Gene Therapy, 2003, pp. 1-7, vol. 3, No. 6.
High et al., Immune Response to AAV and to Factor IX in a Phase I Study of AAV-Mediated, Liver-Directed Gene Transfer for Hemophilia B, Molecular Therapy, May 2004, pp. S383-S384, vol. 9, Supplement 1.
Raper et al., Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer, Abstract, Molecular Genetics and Metabolism, Sep.-Oct. 2003, pp. 148-158, vol. 80.

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