[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87942-87943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; 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 in the U.S. to achieve 
expeditious commercialization of results of federally-funded research 
and development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing 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, MSC 2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Notice of Licensing of Government-Owned 
Inventions in accordance with 35 U.S.C. 209 and 37 CFR part 404. 
Technology description follows.

ApoA-1 Mimetic Peptides Promoting Lipid Efflux From Cells for Treatment 
of Vascular Disorders

    Description of Technology: This invention involves ApoA-1 mimetic 
peptides with multiple amphipathic alpha-helical domains that promote 
lipid efflux from cells and are useful in the treatment and prevention 
of dyslipidemic, inflammatory and vascular disorders. IND-enabling 
studies for one of the peptides, named Fx-5A, are completed in 
preparation for an IND filing at the FDA, to be followed by a Phase I 
clinical trial planned for 2017. Disorders amenable to treatment with 
the peptides include hyperlipidemia, hyperlipoproteinemia, 
hypercholesterolemia, HDL deficiency, hypertriglyceridemia, apoA-I 
deficiency, acute coronary syndrome, angina pectoris, aortic valve 
stenosis, atherosclerosis, carotid atherosclerosis, congestive heart 
failure, cerebral stroke, coronary artery disease, inflammation of the 
cardiovascular system, intermittent claudication, myocardial 
infarction, peripheral vascular disease, post-ischemic reperfusion, 
renal artery stenosis, reperfusion myocardial injury, restenosis, and 
thrombotic stroke.
    Potential Commercial Applications:
     Treatment and prevention of many hereditary, chronic and 
acute dyslipidemic and vascular disorders, where other treatments are 
not effective or too invasive, such as statins, partial ileal bypass 
surgery, portacaval shunt, liver transplantation, and removal of 
atherogenic lipoproteins by one of several apheresis procedures.
     Also applicable to the treatment of inflammation, asthma, 
colitis, inflammatory bowel disease (IBD), chronic kidney disease 
(CKD).
    Development Stage: Early-stage; In vitro data available; In vivo 
data available (animal)
    Inventors: Alan T. Remaley, Stephen J. Demosky, John A. Stonik, 
Marcelo J.A. Amar, Edward B. Neufeld, Fairwell Thomas, H. Bryan Brewer 
(all of NHLBI)

Publications:

1. Jin X, et al. ABCA1 (ATP-Binding Cassette Transporter A1) 
Mediates ApoA-I (Apolipoprotein A-I) and ApoA-I Mimetic Peptide 
Mobilization of Extracellular Cholesterol Microdomains Deposited by 
Macrophages. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2283-
2291. [PMID 27758769]
2. Nowacki TM, et al. The 5A apolipoprotein A-I (apoA-I) mimetic 
peptide ameliorates experimental colitis by regulating monocyte 
infiltration. Br J Pharmacol. 2016 Sep;173(18):2780-92. [PMID 
27425846]
3. Yao X, et al. The A's Have It: Developing Apolipoprotein A-I 
Mimetic Peptides Into a Novel Treatment for Asthma. Chest. 2016 
Aug;150(2):283-8. [PMID 27327118]
4. Souza AC, et al. Antagonism of scavenger receptor CD36 by 5A 
peptide prevents chronic kidney disease progression in mice 
independent of blood pressure regulation. Kidney Int. 2016 
Apr;89(4):809-22. [PMID 26994575]
5. Schwendeman A, et al. The effect of phospholipid composition of 
reconstituted HDL on its cholesterol efflux and anti-inflammatory 
properties. J Lipid Res. 2015 Sep;56(9):1727-37. [PMID 26117661]
6. Sviridov DO, et al. Hydrophobic amino acids in the hinge region 
of the 5A apolipoprotein mimetic peptide are essential for promoting 
cholesterol efflux by the ABCA1 transporter. J Pharmacol Exp Ther. 
2013 Jan;344(1):50-8. [PMID 23042953]
7. Dai C, et al. Apolipoprotein A-I attenuates ovalbumin-induced 
neutrophilic airway inflammation via a granulocyte colony-

[[Page 87943]]

stimulating factor-dependent mechanism. Am J Respir Cell Mol Biol. 
2012 Aug;47(2):186-95. [PMID 22427535]
8. Yao X, et al. 5A, an apolipoprotein A-I mimetic peptide, 
attenuates the induction of house dust mite-induced asthma. J 
Immunol. 2011 Jan 1;186(1):576-83. [PMID 21115733]
9. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: 
Mechanisms of action as anti-atherogenic agents. Pharmacol Ther. 
2011 Apr;130(1):83-91. [PMID 21172387]
10. D'Souza W, et al. Structure/function relationships of 
apolipoprotein a-I mimetic peptides: implications for 
antiatherogenic activities of high-density lipoprotein. Circ Res. 
2010 Jul 23;107(2):217-27. [PMID 20508181]
11. Amar MJ, et al. 5A apolipoprotein mimetic peptide promotes 
cholesterol efflux and reduces atherosclerosis in mice. J Pharmacol 
Exp Ther. 2010 Aug;334(2):634-41. [PMID 20484557]
12. Tabet F, et al. The 5A apolipoprotein A-I mimetic peptide 
displays antiinflammatory and antioxidant properties in vivo and in 
vitro. Arterioscler Thromb Vasc Biol. 2010 Feb;30(2):246-52. [PMID 
19965776]
13. Sethi AA, et al. Asymmetry in the lipid affinity of bihelical 
amphipathic peptides. A structural determinant for the specificity 
of ABCA1-dependent cholesterol efflux by peptides. J Biol Chem. 2008 
Nov 21;283(47):32273-82. [PMID 18805791]

    Intellectual Property: NIH Reference No. E-114-2004/0--Issued 
Patents:

 US 7,572,771 issued 2009-11-08;
 US 8,071,746 issued 2011-12-06;
 US 8,148,323 issued 2012-04-03;
 US 8,835,378 issued 2014-09-16;
 AU 2005295640 issued 2011-11-10;
 CA 2584048 issued 2016-08-09;
 EP 1812474 issued 2010-05-26, validated in CH, DE, ES, FR, GB 
and IT; and
 JP 5,091,679 issued 2012-09-21.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; [email protected].
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize ApoA-1 mimetic peptides. For collaboration 
opportunities, please contact Denise Crooks, Ph.D. at 301-435-0103 or 
[email protected].

    Dated: November 30, 2016.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-29151 Filed 12-5-16; 8:45 am]
 BILLING CODE 4140-01-P