[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