[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Pages 58404-58405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Use of Adenosine Agonists To Prevent Arterial Vascular Calcification 
Disorder

    Description of Invention: Scientists at the National Human Genome 
Research Institute (NHGRI) and the National Heart Lung and Blood 
Institute (NHLBI) at the National Institutes of Health (NIH) have 
discovered a genetic defect in the Ecto-5'-nucleotidase (NT5E) gene 
which results in Cluster of Differentiation 73 (CD73) deficiency that 
leads to a decrease in adenosine, and ultimately, an increase in 
vascular calcification. NT5E encodes CD73, an enzyme that converts 
adenosine monophosphate (AMP) to adenosine in the extracellular region 
of the vascular endothelium. Normally, extracellular adenosine binds to 
one of the several receptors on the surface decreasing the production 
of cyclic AMP (cAMP) resulting in an inhibition of vascular 
calcification.
    The discovery of this genetic mutation leading to a decrease in 
adenosine provides a method of treating or preventing the disorder by 
using adenosine receptor agonists as therapeutic agents. Adenosine 
receptor agonists can be used to treat or prevent disorders associated 
with vascular and/or joint capsule calcification, including for example 
atherosclerosis, Monkeberg's medial sclerosis, CD74 deficiency, Ehlers 
Danlos syndrome (EDS), Marfan/Loewe Dietz syndrome, fibromuscular 
dysplasia, Kawasaki syndrome, pseudoxanthoma elasticum, and premature 
placental calcification.
    Applications: Treatment for vascular calcification disorder by 
using adenosine receptor agonist agents.
    Development Status: Early-stage.
    Inventors: William A. Gahl (NHGRI), Thomas C. Markello (NHGRI), 
Shira G. Ziegler (NHGRI), Manfred Boehm (NHLBI), Cynthia Hillaire 
(NHLBI).
    Publication: C St. Hilaire, et al. NT5E Mutations are Associated 
with Arterial Calcifications. New Engl J Med., Submitted 2010.
    Patent Status: U.S. Provisional Application No. 61/319,336 filed 31 
Mar 2010 (HHS Reference No. E-094-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Steve Standley, 301-435-4074, [email protected].
    Collaborative Research Opportunity: The NHGRI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize adenosine 
receptor agonist compounds for therapeutic use including as a treatment 
of certain common as well as rare vascular calcification-related 
disorders (see above Description of Invention). Please contact NHGRI 
Technology Development Coordinator Claire T. Driscoll at 
[email protected] for more information.

Small Molecule Neuropeptide S Receptor (NPSR) Antagonists for the 
Treatment of Addictive Disorders, Mood, Anxiety and Sleep Disorders

    Description of Invention: The inventors, who work for the National 
Human Genome Research Institute (NHGRI) and the National Institute on 
Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of 
Health (NIH), have developed NPSR antagonists that hold the potential 
for being clinically useful treatments for alcohol and drug addiction. 
Neuropsychiatric disorders including, for example, mood, anxiety, 
eating, and sleep related disorders, as well as alcoholism and drug 
addiction, are major causes of mortality and morbidity. Patient relapse 
into drug seeking and use, after an interval of sobriety, is a key 
component of the addictive syndrome, with approximately two-thirds of 
patients relapsing within three months of initiating abstinence. 
Therefore, relapse prevention is a major treatment objective.
    Neuropeptide S (NPS), an endogenous ligand for the Neuropeptide S 
receptor (NPSR) has recently been shown to play a key role in relapse-
like behavior. In addition, because mood, anxiety, eating, and sleep 
related behaviors are often closely linked with the addictive process, 
and are also affected by the NPS system, it is believed that the NPSR 
antagonist will also be promising as a useful therapeutic target in 
these clinical areas as well.
    Applications: Development of a NPSR antagonist for the therapies of 
alcohol and drug addiction.
    Development Status: Early-stage.
    Market: More than 700,000 Americans receive alcoholism treatment on 
any

[[Page 58405]]

given day by using the traditional alcoholism therapy based on clinical 
experience and intuition, with little rigorous validation of their 
effectiveness (http://health.nih.gov/topic/Alcoholism/SubstanceAbuse). 
About 18% of American adults have anxiety disorders (www.nimh.nih.gov). 
More than 40 million Americans suffer from chronic, long-term sleep 
disorders, and an additional 20 million report sleeping problems 
occasionally (http://www.adaa.org).
    Inventors: Juan J. Marugan, Ke Liu, Samarjit Patnaik, Noel T. 
Southall, Wei Zheng (all with NHGRI); Markus Heilig (NIAAA).
    Related Publication: N Cannella et al. Persistent increase of 
alcohol-seeking evoked by neuropeptide S: An effect mediated by the 
hypothalamic hypocretin system. Neuropsychopharmacology. 2009 Aug; 
34(9): 2125-2134. [PubMed: 19322167].
    Patent Status: U.S. Provisional Application No. 61/328,900 filed 28 
Apr 2010 (HHS Reference No. E-041-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Steve Standley, PhD; 301-435-4074; 
[email protected].
    Collaborative Research Opportunity: The NIH Chemical Genomics 
Center (NCGC), NHGRI, NIH is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize these NPSR antagonist small 
molecule compounds for various therapeutic uses including treatment of 
neuropsychiatric disorders and alcohol and drug addiction. Please 
contact Dr. Juan J. Marugan at [email protected] for more 
information.

A Rapid, Peripheral Blood Gene Expression Biomarker Panel for Diagnosis 
of Acute Ischemic Stroke

    Description of Invention: There are presently no rapid, accurate 
diagnostic procedures or methods that can be used to determine whether 
a patient has suffered an acute ischemic stroke (AIS). Current 
technologies for diagnosis of AIS are limited by speed and resources as 
well as inaccuracy and generally require a high level of training to 
interpret the results for medical technicians. In contrast, this 
invention may lead to the development of a rapid and accurate clinical 
diagnostic kit that would require very little training for proper use 
and could be used in the field or the emergency room setting.
    Scientists at the National Institutes of Health have discovered 
that expression levels of a set of nine genes may be used as biomarkers 
for diagnosis of AIS as well as outcome prediction. These biomarkers 
may be rapidly identified using peripheral whole blood and may form the 
basis of a rapid and accurate clinical point of care diagnostic kit.
    Further, if validation is positive, this technology may enable 
rapid differential diagnosis between acute ischemic stroke and 
hemorrhagic stroke, transient ischemic attack, or any pathology 
mimicking a stroke. Not only can this be used to identify stroke 
earlier in the course of treatment, this panel may also help to better 
characterize stroke subtype, and identify new pathways for stroke 
treatment. This is important as the only FDA approved treatment for 
acute ischemic stroke is tissue plasminogen activator (tPA) and tPA 
must not be given to hemorrhagic stroke patients since it could 
increase intracranial bleeding. To effectively treat AIS, tPA must be 
administered intravenously within 3-4 hours of known stroke onset. 
Because the differential diagnosis of AIS versus hemorrhagic stroke is 
difficult without specialized imaging equipment such as a CT scan with 
contrast or an MRI image, only a small percentage of stroke patients 
(3-5%) are ever given tPA. So, a rapid and accurate clinical diagnostic 
kit based on this invention would have a profound public health benefit 
and likely a large commercial potential.
    Applications:
     A rapid and accurate clinical diagnostic kit for acute 
ischemic stroke.
     Differentiation between acute ischemic stroke and a 
hemorrhagic stroke, transient ischemic attack, or any pathology 
mimicking a stroke.
     Aid in the prediction of outcome and identify new pathways 
for ischemic stroke treatment.
    Advantages: Faster, more accurate, and requires less training than 
currently available diagnostic procedures.
    Development Status: Clinical Validation Pilot Study: Whole blood 
was collected in a clinical setting and gene expressions were 
subsequently profiled.
    Market: Every year, about 795,000 people in the United States have 
a stroke, and about 675,000 of those strokes are ischemic. In 2006, 
137,000 people in the United States died of stroke (http://www.cdc.gov/stroke/).
    Inventors: Taura L. Barr (NINR), Maria Del Mar Matarin Jimenez 
(NIA), Steven J. Warach (NINDS), Andrew B. Singleton (NIA), Jinhui Ding 
(NIA), Allissa A. Dillman (NIA), Mark P. Cookson (NIA), Yvette Conley 
(University of Pittsburgh).
    Publication: Barr, T.L.; Conley, Y.; Ding, J.; Dillman, A.; Warach, 
S.; Singleton, A.; Matarin, M. Genomic biomarkers and cellular pathways 
of ischemic stroke by RNA gene expression profiling; Neurology, Volume 
75(11), 14 September 2010, pp 1009-1014.
    Patent Status: U.S. Provisional Application No. 61/307,233 filed 23 
Feb 2010 (HHS Reference No. E-023-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey Clark Klein, PhD; 301-594-4697; 
[email protected].
    Collaborative Research Opportunity: The NINR is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a point of care 
test for ischemic stroke diagnostics and outcome prediction. Please 
contact Dr. Taura Barr at 304-293-0503 or [email protected] for more 
information.

    Dated: September 20, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-23957 Filed 9-23-10; 8:45 am]
BILLING CODE 4140-01-P