[Federal Register Volume 72, Number 139 (Friday, July 20, 2007)]
[Notices]
[Pages 39824-39825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14031]


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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.

Photosensitization by Nuclear Receptor-Ligand Complexes and Cell 
Ablation Uses Thereof

    Description of Technology: Androgen receptors (AR) mediate the 
effects of male steroid hormones and contribute to a wide variety of 
physiological and pathophysiological conditions. Prostate cancer 
development and progression are mediated through AR, a ligand-dependent 
transcription factor, and it is present in all stages of prostate 
carcinoma. Increased levels of PSA, an AR-induced prostate tumor-
specific protein, are indicative of prostate cancer. Benign, non-
cancerous conditions are also AR-dependent and can be therapeutic 
targets as well.
    This technology is a method to cause AR-induced cell death 
(apoptosis) through photoactivation of a non-steroidal androgen 
receptor antagonist 1,2,3,4-tetrahydro-2,2-dimethyl-6-
(trifluoromethyl)-8-pyridono[5,6-g] quinoline (TDPQ). Upon TDPQ binding 
to AR, a highly potent photocytoxic reaction induced once the TDPQ-AR 
complex is exposed to visible light irradiation of a specific 
wavelength. The inventors have cell-culture results demonstrating that 
cell death is a function of TDPQ, AR and light irradiation. This 
treatment method can potentially target AR-containing cancerous cells, 
while sparing nearby cells that lack AR.
    The process has been extended to other nuclear receptors by choice 
of other photoactivatable ligands for these receptors. Certain suitable 
ligands are marketed drugs.
    Applications: Therapeutic compounds to treat AR related conditions 
such as prostate cancer, baldness, hirsutism, and acne; Potential 
therapeutics for progesterone and glucorticoid receptor ligand related 
conditions such as breast and brain cancers, lymphoma, leukemia and 
arthritis; Method to treat androgen,

[[Page 39825]]

progesterone, and glucorticoid receptor related conditions.
    Market: Prostate cancer is the second most common type of cancer 
among men, wherein one in six men will be diagnosed with prostate 
cancer; An estimated 218,890 new cases of prostate cancer and 27,050 
deaths due to prostate cancer in the U.S. in 2007; Hirsutism affects 
approximately 5% of adult women in the United States; Hair loss and 
acne industries are worth several billions of dollars.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: William T. Schrader et al. (NIEHS).
    Publications:
    1. B Risek et al. Androgen Receptor-Mediated Apoptosis is Regulated 
by Photoactivatable AR Ligands. Abstract submitted to the Endocrine 
Society; To be presented at the Annual Meeting of the Endocrine Society 
in Toronto, Canada in June 2007.
    2. B Risek et al. Photocytotoxic Properties of the Non-Steroidal 
Androgen Receptor Antagonist TDPQ. Presented at the Annual Meeting of 
the Endocrine Society in Boston, MA in June 2006.
    Patent Status: U.S. Provisional Application No. 60/926,218 filed 24 
Apr 2007 (HHS Reference No. E-108-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

Method of Treating or Preventing Oxidative Stress-Related Diseases 
(Stroke and Neurodegenerative Diseases, Wound Healing and 
Cardiovascular Diseases)

    Description of Technology: Reactive oxygen species (ROS) and 
reactive nitrogen species (RNS) produce oxidative stress to DNA, lipids 
and proteins thus causing cellular and tissue damage. A number of 
diseases are associated with oxidative stress including Alzheimer's 
disease, ischemic stroke, heart disease, cancer, hepatitis, and 
autoimmune disease. Uric acid is a natural antioxidant effective in 
reducing ROS and research has shown that uric acid contributes 
approximately two-thirds of all free radical scavenging capacity in 
plasma. Because uric oxide is too insoluble to be used as a therapeutic 
agent, scientists at the NIH developed uric acid analogs with improved 
anti-oxidative and solubility properties for use as free radical 
scavengers or antioxidants. These analogs increased survival of PC12 
and hippocampal neurons after challenge by Fe, MPP and Glutamate. When 
administered to a mouse model of focal ischemic stroke, these compounds 
protect neuronal cells from ROS and reduce brain damage and ameliorate 
neurological deficits. Other studies show a single application of these 
analogs on skin lacerations in mice decreased the time for wound 
repair. Available for licensing are methods of treating ischemic stroke 
and wound healing, and for the prevention or treatment of other 
oxidative stress-related diseases, such as epilepsy, Parkinson's 
disease and dementia.
    Applications: Novel uric acid analogs for use as antioxidants to 
help reduce the risk of stroke, neurological diseases and assisting 
with wound repair.
    Market: Stroke is the third-leading cause of death and the leading 
cause of severe neurological disability worldwide; Americans will pay 
approximately $62.7 billion dollars in 2007 for stroke-related medical 
costs and disability.
    Development Status: Pre-clinical data.
    Inventors: Nigel H. Greig (NIA), Mark P. Mattson (NIA), et al.
    Patent Status: U.S. Provisional Application No. 60/839,800 filed 23 
Aug 2006 (HHS Reference No. E-059-2006/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Norbert Pontzer, PhD, J.D.; 301/435-5502; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Neurosciences, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize the described uric acid 
analogue technology in the treatment of neurodegenerative diseases, 
wound healing and cardiovascular disease. Please contact John D. Hewes, 
PhD at 301-435-3121 or [email protected] for more information.

Thiazepine Inhibitors of HIV-1 Integrase

    Description of Technology: The human immunodeficiency virus (HIV) 
is the causative agent of acquired immunodeficiency syndrome (AIDS). 
Drug resistance is a critical factor contributing to the gradual loss 
of clinical benefit of treatments for HIV infection. Accordingly, 
combination therapies have further evolved to address the mutating 
resistance of HIV. However, there has been great concern regarding the 
apparent growing resistance of HIV strains to current therapies.
    It has been found that a certain class of compounds including 
thiazepines and analogs and derivatives thereof are effective and 
selective anti-integrase inhibitors. These compounds have been found to 
inhibit both viral replication and the activity of purified HIV-1 
integrase. The subject invention provides for such compounds and for 
methods of inhibiting HIV integrase.
    Inventors: Yves Pommier et al. (NCI).
    Patent Status: U.S. Patent No. 7,015,212 issued 21 Mar 2006 (HHS 
Reference No. E-036-1999/0-US-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sally Hu, PhD, MBA; 301/435-5606; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Molecular 
Pharmacology of the National Cancer Institute is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize anti-integrase 
inhibitors. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

     Dated: July 13, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-14031 Filed 7-19-07; 8:45 am]
BILLING CODE 4140-01-P