[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12007-12008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04069]


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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, 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 to achieve expeditious 
commercialization of results of federally-funded research and 
development.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
patent applications may be obtained by emailing Brian W. Bailey, Ph.D., 
[email protected], the indicated licensing contact at the National 
Heart, Lung, and Blood, Office of Technology Transfer and Development 
Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, 
Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: 
    Technology description follows.

Use of Statins To Treat or Prevent Drug-Induced Hearing Loss

Description of Technology

    Available for licensing and commercial development are patent 
rights covering methods of using atorvastatin and related statin 
compounds and derivatives to reduce or prevent drug-induced hearing 
loss that is caused as a side effect by ototoxic drugs such as 
cisplatin, which is commonly used in cancer therapies. At present, 
permanent hearing loss occurs in approximately half of all patients 
treated with cisplatin; consequently, every year many thousands of 
individuals experience partial loss of hearing and associated quality 
of life issues as a result of medically necessary chemoradiation 
therapies to treat their cancers. This technology addresses a large 
unmet need to eliminate or reduce hearing loss in patients that must 
undergo therapies involving ototoxic drugs.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Repurposing existing statins, including atorvastatin, to 
treat or protect against permanent hearing loss arising from 
chemoradiation therapy involving ototoxic drugs.
     Development of statin analogues or derivatives with 
enhanced abilities to treat or protect against hearing loss resulting 
from therapies involving cisplatin or other ototoxic drugs.

[[Page 12008]]

Competitive Advantages

     This invention addresses an urgent need to protect against 
permanent hearing loss resulting from therapies with commonly used but 
ototoxic drugs, including cisplatin.
     Statins are already extensively used therapeutically to 
lower blood cholesterol and have well understood drug profiles, making 
them ideal candidates for repurposing.
    Development Stage: An observational clinical trial (NCT03225157) in 
patients with head and neck cancers has been completed.
    Inventors: Lisa Lynn Cunningham (NIDCD), Nicole C. Schmitt (NIDCD), 
and Katharine Ann Fernandez (NIDCD).
    Publications: J Clin Invest. 2021;131(1):e142616.
    Intellectual Property: HHS Reference No. E-029-2020--PCT/US21/14918 
filed January 25, 2021; U.S. Patent Application No. 62/966,794 filed 
January 28, 2020.
    Licensing Contact: Brian W. Bailey, Ph.D.; 301-594-4094; 
[email protected].

Bruce D. Goldstein,
Director, National Heart, Lung, and Blood Institute, Office of 
Technology Transfer and Development, National Institutes of Health.
[FR Doc. 2021-04069 Filed 2-26-21; 8:45 am]
BILLING CODE 4140-01-P