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Use of E-Selectin Tolerization as Treatment for Immunological and Vascular-Related Disorders

Posted May 14 2012 8:00pm

Description of Invention:
This technology relates to the mucosal delivery (e.g. intranasal) of an E-selectin fragment as a tolerization agent for the prevention and treatment of immunological and vascular-related disorders, including stroke and multiple sclerosis (MS) as well as rare or orphan diseases involving vascular modulated disorders.

E-selectin is an adhesion molecule that is expressed on endothelial cells lining blood vessels in response to certain localized cytokines, making the endothelial surface pro-coagulant, pro-inflammatory and/or immunoreactive. Such changes on the endothelial surface have been linked to the development of vascular-related disorders like stroke, as well as immune regulated diseases such as MS.

Intranasal administration of E-selectin, using a tolerizing dosing schedule, induces an immunological tolerance to E-selectin. T regulatory cells become targeted to activating blood vessel segments, where they release immunomodulatory cytokines such as IL-10. This release of cytokines suppresses local pro-coagulant, pro-inflammatory and immunoreactive effects. Thus, administration of E-selectin as a tolerizing agent will provide a targeted therapeutic approach, impacting only affected sites in the endothelium.

Treatment of diseases biologically based on vascular initiated immune regulation. Such disorders include prevention of secondary stroke, MS, Alzheimer’s, Parkinson’s, rheumatoid arthritis, type 1 diabetes, and psoriasis.

  • Low doses utilized thus minimizing potential side effects.
  • Animal data are available, with further studies currently on-going.
  • Administration through the intranasal route represents a less invasive mode of delivery.
  • FDA pre-IND meetings have been held and FDA communications are ongoing.

Development Status:
  • Pre-clinical
  • In vitro data available
  • In vivo data available (animal)

John M Hallenbeck (NINDS)
Maria Spatz (NINDS)
Hidetaka Takeda (NINDS)
Hideaki Wakita (NINDS)

Patent Status:
HHS, Reference No. E-237-1999/0
US, , Patent No. 7,261,896, Issued 28 Aug 2007
US, Application No. 11/820,326 filed 19 Jun 2007
US, , Patent No. 7,897,575, Issued 01 Mar 2011
US, Application No. 12/859,048 filed 18 Aug 2010

and Foreign counterparts in Australia, Canada, Europe, and Japan

Relevant Publication:
  1. Li X, et al. [ PMID 21701687 ]
  2. Hallenbeck J. [ PMID 20955418 ]
  3. Ishibashi S, et al. [ PMID 19107136 ]
  4. Wakita H, et al. [ PMID 17637705 ]
  5. Nakayama T, et al. [ PMID 17188657 ]
  6. Illoh K, et al. [ PMID 16596122 ]
  7. Chen Y, et al. [ PMID 14645708 ]
  8. Takeda H, et al. [ PMID 12215580 ]

Collaborative Research Opportunity:
The Stroke Branch, NINDS/NIH, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize the applications of E-selectin tolerization in treatment of neurological based disease. For collaboration opportunities, please contact Laurie Arrants, NINDS at .

For Licensing Information Please Contact:
Tara Kirby Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Phone: 301-435-4426
Fax: 301-402-0220

Ref No: 440

Updated: 05/2012

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