[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53887-53888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23312]


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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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.

FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301-594-8730; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Use of Rostafuroxin To Inhibit Viral Infection

    Description of Technology: Acute respiratory infections during 
early childhood constitute a major human health burden. Human 
respiratory syncytial virus (RSV) is the most common and important 
viral cause of severe acute pediatric respiratory infections worldwide. 
Mortality due to RSV in the post-neonatal (28 days to 1 year old) 
population is second only to malaria. It is estimated that RSV causes 
34 million lower respiratory tract infections, 4 million 
hospitalizations, and 66,000-199,000 deaths every year in children less 
than 5 years of age.

[[Page 53888]]

Most mortality occurs in the developing world where clinical care is 
less accessible. Mortality is low in the developed countries, but the 
morbidity is substantial: In the United States alone, RSV is associated 
with an estimated 132,000-172,000 hospitalizations annually in children 
less than 5 years old. There is not yet available a vaccine or an 
effective antiviral drug suitable for routine use.
    This invention relates to a broadly antiviral small chemical 
molecule, Rostafuroxin, expected to be well tolerated in humans and 
available for clinical evaluation. In particular, this patent 
application relates to the novel and unexpected finding that 
Rostafuroxin substantially inhibits RSV infection.
    ATP1A1 is a host protein involved with cellular entry of RSV. RSV 
entry was found to require activation of a signaling cascade mediated 
by ATP1A1 which resembles the signaling pathway (also mediated by 
ATP1A1) triggered by cardiotonic steroids.
    Though not evaluated for RSV, ATPA1A was previously implicated as a 
pro-viral factor in the infection cycles of a number of viruses, but 
the nature of its involvement and mechanism of action were unknown.
    Rostafuroxin, a synthetic digitoxigenin derivative, is a small-
molecule that is known to specifically bind ATP1A1. It has not been 
previously known to have any antiviral activity.
    The inventors have evidence that Rostafuroxin inhibits RSV 
infection in respiratory epithelial cells. Rostafuroxin inhibits RSV 
induced ATP1A1-mediated signaling pathway required for RSV entry. This 
was demonstrated in A549 cells, a widely used human respiratory 
epithelial cell line, and in primary human airway epithelial cells 
derived from a healthy human.
    Rostafuroxin has been previously tested in clinical studies as an 
anti-hypertensive agent. It has no adverse effects in healthy humans 
and, importantly, does not lower the normal systolic blood pressure of 
healthy individuals.
    Rostafuroxin is a promising anti-viral drug candidate for RSV and 
possibly other viruses that use the same pathway for host cell entry.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:

 Viral therapeutics
 Viral diagnostics
 Vaccine research

    Competitive Advantages:

 Ease of manufacture
 Broad antiviral activity
 Favorable safety profile in clinical trials

    Development Stage:

 In vivo data assessment (animal)

    Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Peter 
Collins (NIAID).
    Intellectual Property: HHS Reference No. E-202-2018-0--U.S. 
Provisional Application No. 62/737,899, filed September 27, 2018 
(pending).
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; [email protected].

    Dated: October 15, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-23312 Filed 10-24-18; 8:45 am]
 BILLING CODE 4140-01-P