USE OF EPIDERMAL GROWTH FACTOR FOR THE MORPHOFUNCTIONAL RESTORATION OF PERIPHERAL NERVES IN DIABETIC NEUROPATHY

• US 20100136062A1
• Filed: 10/01/2007
• Published: 06/03/2010
• Est. Priority Date: 10/03/2006
• Status: Active Grant

• Current Assignee: Centro De Ingenieria Genetica Y Biotecnologia
• Original Assignee: Centro De Ingenieria Genetica Y Biotecnologia
• Inventors: Cibrian Vera, Danay, Fernandez Montequin, Jose Ignacio, Berlanga Acosta, Jorge Amador, Garcia Del Barco Herrera, Diana, Herrera Martinez, Luis Saturnino, Saez Martinez, Vivian Maria, Ubieta Gomez, Raimundo, Guillen Nieto, Gerardo Enrique, Gonzalez Blanco, Sonia
• Granted Patent: US 8,642,552 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 9/16 Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/485 Epidermal growth factor [EGF], i.e. urogastrone
• CPC Class Codes: Y10S 930/12 Growth hormone, growth factor other than t-cell or b-cell growth factor, and growth hormone releasing factor; related peptides

Abstract

The invention relates to human medicine and to the use of epidermal growth factor (EGF) for preparing a pharmaceutical composition which is administered by infiltration into the periphery of nerve ganglia and/or trunks for the morphofunctional restoration of peripheral nerves in painful sensory-motor neuropathy as well as manifestations of ischemic neuritis. The invention also includes a composition containing EGF which can be formulated together with anaesthetics or analgesics or encapsulated in microspheres and to the use thereof for the morphofunctional restoration of peripheral nerves in painful sensitive-motor-type diabetic neuropathy and the manifestations of ischemic neuritis.

Claims

1. The use of Epidermal Growth Factor (EGF) to prepare a pharmaceutical composition administered by infiltration in the periphery of nerve trunks and/or ganglia, for the morphofunctional restoration of the peripheral nerves affected by diabetic neuropathy.

2. The use of Epidermal Growth Factor (EGF) according to claim 1 where diabetic neuropathy refers to sensitive-motor, painful neuropathy, and ischemic neuritis.

3. The use of EGF according to claim 1, wherein sensitive-motor, painful neuropathy, or ischemic neuritis affect the lower limbs.

4. The use of EGF according to claim 1, wherein said growth factor is the human, recombinant EGF.

5. The use of EGF according to claim 1, wherein said EGF is encapsulated in microspheres.

6. The use of EGF according to claim 1, wherein said EGF containing pharmaceutical composition is liquid or lyophilized to be reconstituted before its use.

7. The use of EGF according to claim 6, wherein said EGF containing pharmaceutical composition is an aqueous composition, optionally buffered, or a lyophilized composition to be reconstituted with water, or with an aqueous buffer solution.

8. The use of EGF according to claim 1 wherein said pharmaceutical composition, contains from 10 to 1000 micrograms of EGF/milliliter.

9. The use of EGF according to claim 1, wherein said EGF containing pharmaceutical composition, additionally contains from 10 micrograms to 500 milligrams of at least one local anesthetic or analgesic selected among the group of lidocaine, bupivacaine or novocaine.

10. The use of EGF according to claim 9, wherein the local anesthetic is 2% lidocaine.

11. A pharmaceutical composition for the treatment of sensitive-motor, painful diabetic neuropathy;

ischemic neuritis in the periphery of nerve trunks and/or ganglia, for the morphofunctional restoration of the peripheral nerves, which contains EGF in combination with a local anesthetic or analgesic.

12. A pharmaceutical composition according to claim 11 wherein EGF is encapsulated in microspheres.

13. A pharmaceutical composition according to claim 11 wherein the anesthetic is a local anesthetic selected from the group of lidocaine, bupivacaine or novocaine.

14. A pharmaceutical composition according to claim 11 wherein EGF is in the range of 10 to 1000 micrograms/milliliter.

15. The use of the pharmaceutical composition of claim 11 in the morphofunctional restoration of peripheral nerves in sensitive-motor, painful diabetic neuropathy and/or ischemic neuritis.

16. The use of the pharmaceutical composition according to claim 15, to treat any sort of motor fiber damage associated with diabetic neuropathy.