Claims for Patent: 8,900,583

Summary for Patent: 8,900,583

Title:	Methods for treatment of brain injury utilizing biologics
Abstract:	A method of using biologics to treat chronic brain injury or spasticity due to stroke, trauma and other causes. Preferred embodiments include perispinal, parenteral, transepidermal or intranasal use of TNF antagonists. The TNF antagonists include TNF receptor fusion proteins, TNF monoclonal antibodies (mAbs), humanized TNF mAbs, fully human TNF mAbs, chimeric TNF mAbs, domain TNF antibodies, mAB fragments, anti-TNF nanobodies, dominant negative TNF constructs and TNF inhibitory single chain antibody fragments. One of the preferred embodiments of this invention is the perispinal administration of etanercept for treatment of mammals following stroke. The use of Trendelenburg positioning, catheters, pumps, or depot formulations are included.
Inventor(s):	Tobinick; Edward Lewis (Boca Raton, FL)
Assignee:	TACT IP LLC (Boca Raton, FL)
Application Number:	13/848,044
Patent Claims:	1. A method for treating spasticity associated with a chronic brain injury, comprising: administering to a perispinal area of a human who has suffered a brain injury at least 3 months previously and is experiencing spasticity, a therapeutically effective amount of etanercept for treating spasticity. 2. The method of claim 1, wherein said human suffered a brain injury at least 24 months previously. 3. The method of claim 2, wherein the brain injury was a stroke. 4. The method of claim 1, wherein said human suffered a brain injury at least 36 months previously. 5. The method of claim 4, wherein the brain injury was a stroke. 6. The method of claim 1, wherein the etanercept is administered without direct intrathecal injection. 7. The method of claim 1, wherein the etanercept is administered external to ligamentum flavum. 8. The method of claim 1, wherein said human also has a condition selected from the group consisting of a mood disorder, sleep disorder, cognitive disorder, aphasia, hemiplegia, sensory deficit, post-traumatic stress disorder and pain. 9. The method of claim 1, wherein said human is placed in a Trendelenburg position after administering etanercept. 10. The method of claim 1, wherein etanercept is administered epidurally. 11. The method of claim 1, wherein the brain injury was a stroke. 12. The method of claim 1, wherein the chronic brain injury resulted from an acute brain injury. 13. The method of claim 1, wherein an initial dose is followed by one subsequent dose. 14. The method of claim 1, wherein an initial dose is followed by two subsequent doses. 15. The method of claim 1, wherein the etanercept isa dimeric fusion protein consisting of two soluble TNF receptors fused to a Fc portion of an immunoglobulin molecule.

Details for Patent 8,900,583

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2030-11-01
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2030-11-01
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2030-11-01
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2030-11-01