[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Pages 58857-58858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20483]


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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.

Novel Roles of a DNA Repair Protein, DNA-PKcs, in Obesity, Neurological 
Function, and Aging

    Description of Technology: The catalytic subunit of the DNA-
dependent protein kinase complex (DNA-PKcs) has been shown to be 
important in DNA repair and VDJ recombination in lymphocytes. The 
inventors have discovered that DNA-PKcs also plays novel, important 
roles in energy regulation and neurological function. The inventors 
observed that mature DNA-PKcs-deficient mice (also known as SCID mice) 
have a lower proportion of fat, resist obesity, and have significantly 
greater physical endurance than wild-type control mice, particularly 
with increasing age. The inventors also observed that DNA-PKcs-
deficient mice have better memory and less anxiety. One potential 
explanation for this is that they express higher levels of brain-
derived neurotrophic factor (BDNF), which is associated with 
neurogenesis, memory formation and suppression of anxiety and 
depression. Moreover, DNA-PKcs-deficient cells produce less oxidative 
stress. Thus, inhibition of DNA-PKcs may have unexpected utility in the 
treatment of a wide range of diseases and conditions.
    The invention discloses methods of inhibiting DNA-PKcs activity to 
decrease adiposity, improve physical endurance and increase insulin 
sensitivity and the number of mitochondria. Also claimed are methods 
directed to improved neurological function, such as methods for 
protection from neurodegenerative disease, improving memory and 
learning ability, and for reducing depression and anxiety. 
Additionally, the invention discloses methods for reducing inflammation 
and for treating heart disease.
    Applications:
    Development of therapeutics targeting obesity, insulin-resistant 
diabetes, and age-related loss of physical endurance.
    Development of therapeutics to treat neurological disorders such as 
depression and memory loss.
    Market:
    Obesity is a large and growing therapeutic market; over thirty 
percent of Americans are obese, and over sixty percent are overweight.
    Similarly, the market for therapeutics directed to insulin-
resistant, or Type 2, diabetes is rapidly expanding; the market for 
such drugs is expected to top $12 billion in 2012.
    Loss of endurance and muscle mass is common in the elderly; the 
average

[[Page 58858]]

adult loses thirty percent of his muscle mass between the ages of 20 
and 70.
    Development Status: Early stage.
    Inventors: Jay H. Chung et al. (NHLBI).
    Publication: In preparation.
    Patent Status: U.S. Provisional Application No. 60/958,714 filed 06 
July 2007 (HHS Reference No. E-068-2007/0-US-01).
    Licensing Status: This technology is available for exclusive, co-
exclusive, or nonexclusive licensing.
    Licensing Contact: Tara L. Kirby, Ph.D.; 301/435-4426; 
[email protected].
    Collaborative Research Opportunity: The National Heart Lung and 
Blood Institute, Laboratory of Biochemical Genetics, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
DNA-PKcs inhibitors for treatment or prevention of metabolic and 
degenerative diseases. Please contact Jay Chung ([email protected]) 
for more information.

Predictive Diagnostic Test for Anti-Depressant Related Suicide Risk

    Description of Technology: A number of studies have reported a 
potential link between antidepressant treatment and suicides. Although 
the scientific basis for this phenomenon is not known, the Food and 
Drug Administration (FDA) required a black box warning of worsening 
depression and/or emergence of suicidality (i.e., development of 
suicidal thoughts or behavior) in both adult and pediatric patients 
taking several antidepressants. While use of antidepressants fell 
subsequent to the black box warning, recent studies suggest that 
pediatric suicides may actually be rising. This has led to concerns 
that untreated depression due to the black box warning could 
potentially result in an overall increase in suicides.
    To determine whether a genetic basis for suicidal risk exists for a 
sub-group of depressed patients, NIH researchers genetically screened 
patients with major depression treated with the serotonin selective 
reuptake inhibitor (SSRI) citalopram (Celexa) in the NIMH-funded 
Sequenced Treatment Alternatives for Depression (STAR*D) trial. 
Versions of two genes coding for components of the brain's glutamate 
chemical messenger system were linked to suicidal thinking associated 
with antidepressant use. Having both implicated versions increased risk 
of such thoughts more than 14-fold. By identifying those patients who 
need close monitoring, alternative treatments and/or specialty care, 
these genetic tests should prevent the under prescribing of anti-
depressant drugs and the resulting possibility of suicide due to sub-
optimal treatment.
    Applications: Diagnostic tests predicting the likelihood of suicide 
during anti-depressant treatment.
    Market: Depression ranks among the ten leading causes of disability 
and will become the second-largest cause of the global health burden by 
2020. An estimated 121 million people worldwide suffer from a 
depressive disorder for which they require treatment. It is estimated 
that 5.8% of all men and 9.5% of all women will suffer from a 
depressive disorder in any given year and that 17% of all men and women 
will suffer from a depressive disorder at some point in their lives.
    Development Status: Clinical data.
    Inventors: Francis J. McMahon et al. (NIMH).
    Patent Status: U.S. Provisional Application No. 60/854,978 Filed 27 
Oct 2006 (HHS Reference No. E-157-2006/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Norbert Pontzer, Ph.D., J.D.; 301/435-5502; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Mental Health Mood and Anxiety Disorders Program Genetics Unit is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
the Predictive Diagnostic Test for Anti-Depressant Related Suicide. 
Please contact Dr. Francis McMahon at [email protected] for more 
information.

    Dated: October 11, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-20483 Filed 10-16-07; 8:45 am]
BILLING CODE 4140-01-P