Healthpartners Research Foundation

Healthpartners Research & Education

Chiron Corporation

Leland Stanford Junior University

Trigemina, Inc.

The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc.

Baxalta Gmbh

Healthpartners Institute

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University of Minnesota

University of California

Sri International

Takeda Pharmaceutical Company Limited

Geron Corporation

Biopharm Gesellschaft Zur Biotechnologischen Entwicklung Von Pharmaka Mbh

William Howard Frey, Ii

Leah Ranae Bresin Hanson

Samuel Scott Panter

John Randall Fawcett

Daniel Jacobs

David C Yeomans

Martin S Angst

Kimberly Byrnes

Fiona Brabazon

Sharon Pokropinski

Francisco M Rausa

R Scott McIvor

Christoph Gleiter

Lusine Danielyan

Annina Roeytenberg

Daniel A Wolf

Leah R Hanson

Shyeilla V Dhuria

Sergei M Gryaznov

Jens Pohl

John D Hoekman

Richard M Bergenstal

Leah R Hansom

Neil J Johnson

Dennis F Deen

Mary Ann Katherine Greco

Jacqueline DeRose

Rachel Beth Matthews

Samual Scott Panter

Robert Gary Thorne

Anders L Carlson

Francisco M Iii Rausa

The present invention provides, among other aspects, methods and compositions for treating a central nervous system (CNS) disorder by delivering a therapeutically effective amount of a composition of pooled human immunoglobulin G (IgG) to the brain via intranasal administration of the composition directly to the olfactory epithelium of the nasal cavity. In particular, methods and compositions for treating Alzheimer's disease are provided.

Treatment of central nervous system disorders by intranasal administration of immunoglobulin g

The present system is directed in several embodiments to a method of administration of a therapeutic composition for protection of the brain of a subject at risk of injury leading to traumatic brain injury (TBI) and/or treatment of injury to the brain resulting from TBI. The method includes administering one or more therapeutic compositions comprising an effective amount of insulin directly to the subject patient's CNS, with no to minimal systemic exposure. Preferably, this method comprises administration of an effective amount of insulin to the upper third of a patient's nasal cavity, thereby bypassing the patient's blood-brain barrier and delivering the therapeutic composition directly to the patient's central nervous system.

Methods for protecting and treating traumatic brain injury, concussion and brain inflammation with intranasal insulin

The present system is directed in one embodiment to a method of administration of a therapeutic composition for treatment, prevention and/or mitigation of the frequency and/or severity of impaired awareness of hypoglycemia (IAH). The method includes administering one or more therapeutic agent(s) or composition(s) comprising insulin to the upper third of a patient's nasal cavity, thereby delivering the therapeutic composition directly to the patient's central nervous system for treatment, prevention and/or mitigation of the frequency and/or severity of IAH. In still another embodiment, the therapeutic composition comprises a non-zinc containing form of insulin.

Methods for treating patients with impaired awareness of hypoglycemia

Methods for delivering an effective amount of insulin to the central nervous system to treat Social Communication Disorder while minimizing systemic exposure to the administered insulin. The present invention provides these advantages by administering at least an effective amount of insulin and/or pharmaceutical composition(s) thereof, to the upper third of the nasal cavity, thereby bypassing the blood-brain barrier and delivering an effective amount of insulin and/or pharmaceutical compound(s) thereof directly to the CNS. Further methods comprise administering an at least an effective amount of therapeutic agents to the amniotic fluid surrounding a fetus with a treatable neurologic agent or a preventable neurologic condition. For example, administering the at least effective amount of insulin to the amniotic fluid of a fetus with a mother diagnosed with gestational diabetes may prevent the fetus from developing Social Communication Disorder or autism.

Methods of treating and preventing social communication disorder in patients by intranasal administration of insulin

Treatment of central nervous system disorders by intranasal administration of immunoglobulin G

Pharmaceutical compositions and methods for enhancing targeting of therapeutic compounds to, inter alia, the CNS applied via intranasal administration while reducing non-target exposure are provided. In certain embodiments, at least one vasoconstrictor is provided intranasally prior to intranasal administration of at least one therapeutic compound. In other embodiments, the vasoconstrictor(s) and therapeutic compound(s) are combined in a pharmaceutical composition and delivered intranasally. The present invention substantially increases targeting of the therapeutic compound(s) to, inter alia, the CNS while substantially reducing unwanted and potentially harmful systemic exposure. The preferred administration of the invention applies the vasoconstrictor(s) and/or therapeutic compound(s) to the upper third of the nasal cavity, though application to the lower two-thirds of the nasal cavity is also within the scope of the invention.

Pharmaceutical compositions and methods for enhancing targeting of therapeutic compounds to the central nervous system

The present system is directed in several embodiments to a method of administration of a therapeutic composition for treatment of Anorexia Nervosa, safely and without significantly affecting the blood glucose or blood insulin levels of the patient. The method includes administering one or more therapeutic compositions comprising an effective amount of insulin directly to the subject patient's CNS, with no to minimal systemic exposure. Preferably, this method comprises administration of an effective amount of insulin to the upper third of a patient's nasal cavity, thereby bypassing the patient's blood-brain barrier and delivering the therapeutic composition directly to the patient's central nervous system.

Methods of treating anorexia nervosa by intranasal administration of insulin

The present invention is directed to methods for reducing systemic absorption of therapeutic compounds or agents while enhancing efficiency of delivery and targeting of intranasal administration of such compounds or agents to the central nervous system. More specifically, use of ultrasound technology in conjunction with intranasal delivery of a therapeutic compound, or pharmaceutical composition, wherein the intranasal delivery is preferably to the upper one third of a patient's nasal cavity, thereby reducing therapeutic compound or agent absorption into the blood. At the same time, the present invention results in reducing the delivery of therapeutic compounds and/or agents to the peripheral tissues, increases therapeutic delivery of the compounds and/or agents to the central nervous system generally, and increases targeting of the therapeutics and/or agents to specific target regions within the central nervous system.

Methods for using ultrasound for enhancing efficiency and targeting of intranasal administration of therapeutic compounds to the central nervous system

Methods for preconditioning and/or providing neuroprotection to the animal central nervous system against the effects of stoke, including associated cognitive, behavioral and physical impairments. Initially, a patient at risk for stroke is identified. Effective amounts of therapeutic agents are administered to the upper third of the at-risk patient's nasal cavity to bypass the blood-brain barrier and access the central nervous system directly to avoid unwanted and potentially lethal side effects. Therapeutic agents include those substances that interact with iron and/or copper such as iron chelators, copper chelators, and antioxidants. A particular example of a therapeutic agent is the iron chelator deferoxamine (DFO).

Method of pre-treating patients for stroke comprising administering metal chelators to the upper one-third of the nasal cavity

Methods for preconditioning and/or providing neuroprotection to the animal central nervous system against the effects of cerebral hemorrhage and subarachnoid hemorrhage. Therapeutic agents are administered to the upper third of the nasal cavity to bypass the blood-brain barrier and access the central nervous system directly to avoid unwanted and potentially lethal side effects. Therapeutic agents include those substances that interact with iron and/or copper such as iron chelators, copper chelators, and antioxidants. A particular example of such therapeutic agents is the iron chelator deferoxamine (DFO). An effective amount of DFO may be administered to the upper third of the nasal cavity of a patient at risk for, or diagnosed with, cerebral hemorrhage and subarachnoid hemorrhage. The effective amount of DFO is delivered directly to the patient's central nervous system for preconditioning, preventing and/or treating the cerebral hemorrhage and subarachnoid hemorrhage.

Method of treating cerebral hemorrhage and subarachnoid hemorrhage comprising administering metal chelators to the upper one-third of the nasal cavity

Methods for preventing and/or treating symptoms of Post-Traumatic Stress Disorder (PTSD) are provided. The preferred method comprises administration of an effective amount of insulin to the upper one-third of a mammal's, preferably a human, nasal cavity, thereby enabling the administered at least one effective amount of insulin to bypass the patient's blood-brain barrier and be directly delivered to the patient's CNS. Another embodiment comprises utilizing vasoconstrictors to enhance targeting of an effective amount of insulin to the CNS while reducing non-target exposure.

Methods for preventing and treating post-traumatic stress disorder (PTSD)

Growing community of inventors

White Bear Lake, MN, United States of America

William Howard Frey, Ii