[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Pages 16690-16692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06070]



National Institutes of Health

Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.


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.

[[Page 16691]]

FOR FURTHER INFORMATION CONTACT: 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.

Ketone Bodies To Protect Tissues From Damage by Ionizing Radiation

    Description of Technology: The invention relates to methods of 
using ketogenic compounds to protect against the adverse effects of 
radiation exposure, including ionizing radiation tissue damage. NIH 
inventors have discovered that ketone esters can be used to reduce 
tissue damage if administered before or after exposure to radiation. 
Specifically, the invention relates to esters and oligomers of (R)-3-
hydroxybutyrate that are capable of elevating blood levels of (R)-3-
hydroxybutyrate and acetoacetate to sufficient levels to reduce cell 
death caused by radiation-induced damage of DNA and RNA. The 
development of effective radioprotectant molecules such as these is of 
great importance in reducing tissue damage following intentional or 
accidental radiation exposure. This discovery can also increase the 
therapeutic efficacy of radiation therapies by protecting non-target 
tissues from incidental radiation damage.
    Potential Commercial Applications:
     Effective therapeutic agent for reducing tissue damage 
following radiation exposure
     Protects populations subjected to accidental, incidental, 
or military exposure to radiation
     Protects non-target tissue during radiation therapy
    Competitive Advantages:
     Can be administered before or after radiation damage
     Stable at room temperature, allowing easy storage
    Development Stage: In vitro data available.
    Inventor: Richard L. Veech (NIAAA).
    Intellectual Property: HHS Reference No. E-258-2012/0--US 
Application No. 61/722,630 filed 05 Nov 2012.
    Licensing Contact: Charlene Sydnor, Ph.D.; 301-435-4689; 
[email protected].
    Collaborative Research Opportunity: The NIAAA is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize Ketone Bodies to 
Protect Tissues from Damage by Ionizing Radiation. For collaboration 
opportunities, please contact Peter B. Silverman, Ph.D., J.D. at 
[email protected] or 301-402-6966.

mTOR Inhibition for the Prevention of Epithelial Stem Cell Loss and 

    Description of Technology: The integrity of the epidermis and 
mucosal epithelia is highly dependent on self-renewing stem cells and, 
therefore, is vulnerable to physical and chemical damage from common 
cancer treatments, such as radiation or chemotherapy. Consequently, 
many cancer patients undergoing these treatments develop mucositis, a 
debilitating condition involving painful and deep mucosal ulcerations. 
Since current prevention and treatment options for mucositis are 
limited, providing only minor relief and no protection to stem cells, 
novel therapies are needed.
    The NIH inventors have recently discovered that the mammalian 
target of rapamycin (mTOR) mediates stem cells exhaustion in the skin 
and leads to progressive hair loss. More importantly, they have shown 
that mTOR inhibition reduces oxidative stress in the epithelial stem 
cells and mTOR inhibitors can be used to increase the re-populative 
capacity of tissue resident stem cells to maintain tissue homeostasis 
after injury or stress. Therefore, this technology could be used to 
prevent epithelial stem cell loss and provide relief from radiation-
induced mucositis. Likewise, it could be used to prevent mucositis and 
hair loss in patients undergoing chemotherapy and stem cell 
transplantation. For optimal delivery and effectiveness, rapamycin or 
other mTOR inhibitor could be administered in the form of a mouthwash 
or gel product to patients prior to receiving radiation (or other) 
    Potential Commercial Applications: Prevention and treatment of 
epithelial stem cell loss and mucositis.
    Competitive Advantages:
     Reduces the oxidative stress in epithelial stem cells and 
can increase their repopulative capacity.
     Preserves the integrity of the oral mucosa and protects 
from radiation-induced stem cell loss and mucositis.
    Development Stage:
     In vitro data available
     In vivo data available (animal)
    Inventors: Silvio Gutkind (NIDCR), Ramiro Iglesias-Bartolome 
(NIDCR), Vyomesh Patel (NIDCR), Ana Cotrim (NIDCR), Alfredo Molinolo 
(NIDCR), James Mitchell (NCI).
    Publication: Iglesias-Bartolome R, et al. mTOR inhibition prevents 
epithelial stem cell senescence and protects from radiation-induced 
mucositis. Cell Stem Cell. 2012 Sep 7;11(3):401-14. [PMID 22958932].
    Intellectual Property: HHS Reference No. E-257-2012/0--U.S. 
Provisional Application No. 61/696,681 filed 05 Sep 2012.
    Related Technology: HHS Reference No. E-300-2008--U.S. Patent 
Application No. 13/376,984 filed 08 Dec 2011.
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected].

Combination Chemotherapeutics for the Treatment of Chordoma

    Description of Technology: Utilizing high-throughput screening 
methodology, NIH scientists have identified two classes of clinically-
available drugs, proteasome inhibitors and topoisomerase inhibitors, 
that synergize to promote chordoma cell death. Moreover, use of the 
two-part chemotherapeutic regimen in animal models effectively 
suppressed the growth of chordoma cells and resulted in significant 
tumor regression. Currently, no chemotherapeutic agents have been 
approved for the treatment of chordoma. Using FDA approved drugs in a 
combination therapeutic regimen will help expedite the availability of 
a therapeutic for chordoma.
    Chordoma is a rare form of bone cancer that arises within the 
skull, sacrum or bony spine. Surgical resection and radiation therapy 
are the current standards-of-care; however, post-treatment 
complications remain significant and neither modality is effective for 
the control of metastatic tumors.
    Potential Commercial Applications:
     Chemotherapeutic regimen for the treatment of inoperable 
     Therapy for the treatment of recurrent or metastatic 
     Therapeutic kit combining an FDA-approved proteasome 
inhibitor with a topoisomerase inhibitor.
    Competitive Advantages:
     Therapy utilizes FDA-approved drugs with known 
pharmacokinetics and safety profiles.
     Reduced drug dosing from combination therapy may result in 
fewer patient side effects.
     Combination therapy inhibits multiple molecular targets, 
enhancing disease response.
    Development Stage:
     In vitro data available

[[Page 16692]]

     In vivo data available (animal)
    Inventors: Menghang Xia, Ruili Huang, Christopher P. Austin (all of 
    Intellectual Property: HHS Reference No. E-156-2012/0--US 
Application No. 61/692,560 filed 23 Aug 2012.
    Licensing Contact: Sabarni Chatterjee, Ph.D., MBA; 301-435-5587; 
[email protected].
    Collaborative Research Opportunity: The National Center for 
Advancing Translational Sciences, Division of Pre-Clinical Innovation, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
Combination Chemotherapeutics for the Treatment of Chordoma. For 
collaboration opportunities, please contact Lili M. Portilla, MPA at 
[email protected].

     Dated: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-06070 Filed 3-15-13; 8:45 am]