Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...
Reexamination Certificate
2000-05-05
2002-08-13
Crouch, Deborah (Department: 1632)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Recombinant dna technique included in method of making a...
C435S070100, C435S320100, C435S325000, C435S455000
Reexamination Certificate
active
06432676
ABSTRACT:
The present invention relates firstly to a chimeric gene using the gene or CDNA (complementary DNA) of insulin driven by a promoter or fusion of promoters.
More specifically, it relates to the design of a chimeric gene formed by the fusion of the promoter of P-enolpyruvate carboxyquinase to the structural gene of human insulin, which allows the production of human insulin, physiologically regulated, in a tissue different from the pancreas.
The invention further relates to others objects which are described below.
BACKGROUND OF THE INVENTION
Patients suffering from insulin dependent diabetes mellitus (IDDM) (type I) depend dramatically on the administration of the hormone. The interruption of the insulin administration results first in hyperglycemia and ketoacidosis, then coma and finally death if the hormone is not injected. Therefore, the life and the quality of life of these patients depend completely on the fluctuations of the insulin levels in their blood.
Gene therapy consists in the transfer of genetic material into cells of a patient with the purpose of treating an illness. At present, different approximations of gene therapy are being developed, based on the introduction of genes directly into animals or cells which are then transplanted.
However, the most important goal is not to be able to transplant successfully cells expressing the gene in an animal, but to make it possible for the gene to express in a regulated and physiologic way. The choice of a good promoter which drives the expression of the suitable gene is crucial in order to obtain suitable plasmatic levels of the corresponding protein.
In the case of diabetes, the question is to chose the promoter which drives the expression of the gene in order to obtain suitable insulin plasmatic levels for every condition of the individual. The overexpression of the insulin gene would result in hypoglucemia and a low expression of said gene would not modify the high glucose levels in the diabetic process.
REFERENCES:
patent: 6137029 (2000-10-01), Tubert et al.
Ledley; Clinical Considerations in the Design of Protocols for Somatic Gene Therapy, 1991, Human Gene Therapy 2:77-83.*
Eck et al.; Gene-Based Therapy, 1996, Pharmacological Basis of Therapeutics, Chapter 5: 77-101.*
Miller et al.; Targeted vectors for gene therapy, 1995, FASEB J. 9: 190-199.*
Deonarain; Ligand-targeted receptor-mediated vectors for gene delivery, 1998, Exp. Opin. Ther. Patents 8(1): 53-69.*
Verma et al.; Gene therapy- promises, problems and prospects, 1997, Nature, vol. 389: 239-242.*
Crystal; Transfer of Genes to Human: Early Lessons and Obstacles to Success, 1995, Science vol. 270: 404-410.*
Docherty; Gene therapy for diabetes mellitus, 1997, Clinical Science 92: 321-330.*
Freeman et al.; Present and potential future use of gene therapy for the treatment of non-insulin dependent diabetes mellitus(Review); 1999, International Journal of Molecular Medicine4: 585-592.*
Vollenweider, et al., “Processing of Proinsulin by Transfected Hepatoma (FAO) Cells”, The Journal of Biological Chemistry, vol. 267, No. 21, Issue of Jul. 25, pp. 14629-14636, 1992.
Simpson, et al., “Functional expression of human insulin gene in a human hepatoma cell line (HEP G2)”, Gene Therapy (1995), vol. 2, No. 3, May 1995, pp. 223-231.
Kolodka, et al., “Gene therapy for diabetes mellitus in rats by hepatic expression of insulin”, Proc. Natl. Acad. Sci. USA, vol. 92, Apr. 1995, pp. 3293-3297.
Abril Alfons Valera
Tubert Fatima Bosch
Crouch Deborah
Steinberg & Raksin, P.C.
Ton Thai-an N.
Universitat Autonoma de Barcelona
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