81_FR_88176 81 FR 87942 - Government-Owned Invention; Availability for Licensing

81 FR 87942 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 234 (December 6, 2016)

Page Range87942-87943
FR Document2016-29151

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.

Federal Register, Volume 81 Issue 234 (Tuesday, December 6, 2016) 
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87942-87943]
From the Federal Register Online  [www.thefederalregister.org]
[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Disclosure Agreement may be required to receive any unpublished 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

87942 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices Scientific Review, OD, Eunice Kennedy Disorders Research, National Institutes of atherosclerosis, carotid atherosclerosis, Shriver National Institute of Child Health Health, HHS) congestive heart failure, cerebral stroke, and Human Development, NIH, DHHS, Dated: November 28, 2016. coronary artery disease, inflammation of 6710B Rockledge Drive, Bethesda, MD the cardiovascular system, intermittent 20892–7501, 301–435–6878, wedeenc@ Natasha M. Copeland, mail.nih.gov. Program Analyst, Office of Federal Advisory claudication, myocardial infarction, Committee Policy. peripheral vascular disease, post- (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; [FR Doc. 2016–29142 Filed 12–5–16; 8:45 am] ischemic reperfusion, renal artery 93.865, Research for Mothers and Children; BILLING CODE 4140–01–P stenosis, reperfusion myocardial injury, 93.929, Center for Medical Rehabilitation restenosis, and thrombotic stroke. Research; 93.209, Contraception and Potential Commercial Applications: Infertility Loan Repayment Program, National DEPARTMENT OF HEALTH AND • Treatment and prevention of many Institutes of Health, HHS) HUMAN SERVICES hereditary, chronic and acute Dated: November 29, 2016. dyslipidemic and vascular disorders, National Institutes of Health where other treatments are not effective Michelle Trout, or too invasive, such as statins, partial Program Analyst, Office of Federal Advisory Government-Owned Invention; ileal bypass surgery, portacaval shunt, Committee Policy. Availability for Licensing liver transplantation, and removal of [FR Doc. 2016–29141 Filed 12–5–16; 8:45 am] atherogenic lipoproteins by one of BILLING CODE 4140–01–P AGENCY: National Institutes of Health, several apheresis procedures. HHS. • Also applicable to the treatment of ACTION: Notice. inflammation, asthma, colitis, DEPARTMENT OF HEALTH AND inflammatory bowel disease (IBD), HUMAN SERVICES SUMMARY: The invention listed below is owned by an agency of the U.S. chronic kidney disease (CKD). Government and is available for Development Stage: Early-stage; In National Institutes of Health licensing in the U.S. to achieve vitro data available; In vivo data National Institute of Dental & expeditious commercialization of available (animal) Craniofacial Research; Notice of Inventors: Alan T. Remaley, Stephen results of federally-funded research and Closed Meeting J. Demosky, John A. Stonik, Marcelo J.A. development. Amar, Edward B. Neufeld, Fairwell FOR FURTHER INFORMATION CONTACT: Thomas, H. Bryan Brewer (all of NHLBI) Pursuant to section 10(d) of the Federal Advisory Committee Act, as Licensing information may be obtained by emailing the indicated licensing Publications: amended (5 U.S.C. App.), notice is hereby given of the following meeting. contact at the National Heart, Lung, and 1. Jin X, et al. ABCA1 (ATP-Binding Cassette Blood, Office of Technology Transfer Transporter A1) Mediates ApoA-I The meeting will be closed to the and Development Office of Technology (Apolipoprotein A-I) and ApoA-I public in accordance with the Transfer, 31 Center Drive Room 4A29, Mimetic Peptide Mobilization of provisions set forth in sections MSC 2479, Bethesda, MD 20892–2479; Extracellular Cholesterol Microdomains 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., telephone: 301–402–5579. A signed Deposited by Macrophages. Arterioscler as amended. The grant applications and Confidential Disclosure Agreement may Thromb Vasc Biol. 2016 the discussions could disclose Dec;36(12):2283–2291. [PMID 27758769] be required to receive any unpublished 2. Nowacki TM, et al. The 5A apolipoprotein confidential trade secrets or commercial information. property such as patentable material, A–I (apoA-I) mimetic peptide SUPPLEMENTARY INFORMATION: Notice of ameliorates experimental colitis by and personal information concerning Licensing of Government-Owned regulating monocyte infiltration. Br J individuals associated with the grant Pharmacol. 2016 Sep;173(18):2780–92. applications, the disclosure of which Inventions in accordance with 35 U.S.C. 209 and 37 CFR part 404. Technology [PMID 27425846] would constitute a clearly unwarranted 3. Yao X, et al. The A’s Have It: Developing invasion of personal privacy. description follows. Apolipoprotein A-I Mimetic Peptides Name of Committee: National Institute of ApoA-1 Mimetic Peptides Promoting Into a Novel Treatment for Asthma. Dental and Craniofacial Research Special Lipid Efflux From Cells for Treatment Chest. 2016 Aug;150(2):283–8. [PMID of Vascular Disorders 27327118] Emphasis Panel. 4. Souza AC, et al. Antagonism of scavenger Date: December 12, 2016. Description of Technology: This receptor CD36 by 5A peptide prevents Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant invention involves ApoA-1 mimetic chronic kidney disease progression in peptides with multiple amphipathic mice independent of blood pressure applications. alpha-helical domains that promote regulation. Kidney Int. 2016 Place: National Institutes of Health, Two lipid efflux from cells and are useful in Apr;89(4):809–22. [PMID 26994575] Democracy Plaza, 6707 Democracy 5. Schwendeman A, et al. The effect of Boulevard, Bethesda, MD 20892 (Telephone the treatment and prevention of phospholipid composition of Conference Call). dyslipidemic, inflammatory and reconstituted HDL on its cholesterol Contact Person: Guo He Zhang, MPH, vascular disorders. IND-enabling studies efflux and anti-inflammatory properties. Ph.D., Scientific Review Officer, Scientific for one of the peptides, named Fx–5A, J Lipid Res. 2015 Sep;56(9):1727–37. Review Branch, National Institute of Dental are completed in preparation for an IND [PMID 26117661] and Craniofacial Research, National Institutes 6. Sviridov DO, et al. Hydrophobic amino of Health, 6701 Democracy Boulevard, Suite filing at the FDA, to be followed by a Phase I clinical trial planned for 2017. acids in the hinge region of the 5A mstockstill on DSK3G9T082PROD with NOTICES 672, Bethesda, MD 20892, zhanggu@ apolipoprotein mimetic peptide are mail.nih.gov. Disorders amenable to treatment with essential for promoting cholesterol efflux This notice is being published less than 15 the peptides include hyperlipidemia, by the ABCA1 transporter. J Pharmacol days prior to the meeting due to the timing hyperlipoproteinemia, Exp Ther. 2013 Jan;344(1):50–8. [PMID limitations imposed by the review and hypercholesterolemia, HDL deficiency, 23042953] funding cycle. hypertriglyceridemia, apoA-I deficiency, 7. Dai C, et al. Apolipoprotein A-I attenuates (Catalogue of Federal Domestic Assistance acute coronary syndrome, angina ovalbumin-induced neutrophilic airway Program Nos. 93.121, Oral Diseases and pectoris, aortic valve stenosis, inflammation via a granulocyte colony- VerDate Sep<11>2014 17:39 Dec 05, 2016 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1

Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices 87943 stimulating factor-dependent DEPARTMENT OF HEALTH AND Dated: November 29, 2016. mechanism. Am J Respir Cell Mol Biol. HUMAN SERVICES Michelle Trout, 2012 Aug;47(2):186–95. [PMID Program Analyst, Office of Federal Advisory 22427535] National Institutes of Health Committee Policy. 8. Yao X, et al. 5A, an apolipoprotein A-I mimetic peptide, attenuates the [FR Doc. 2016–29140 Filed 12–5–16; 8:45 am] Eunice Kennedy Shriver National induction of house dust mite-induced BILLING CODE 4140–01–P asthma. J Immunol. 2011 Jan Institute of Child Health & Human 1;186(1):576–83. [PMID 21115733] Development; Notice of Closed 9. Osei-Hwedieh DO, et al. Apolipoprotein Meetings DEPARTMENT OF HOMELAND mimetic peptides: Mechanisms of action SECURITY as anti-atherogenic agents. Pharmacol Pursuant to section 10(d) of the Ther. 2011 Apr;130(1):83–91. [PMID Federal Advisory Committee Act, as U.S. Customs and Border Protection 21172387] amended (5 U.S.C. App.), notice is 10. D’Souza W, et al. Structure/function hereby given of the following meetings. Accreditation and Approval of Camin relationships of apolipoprotein a-I mimetic peptides: implications for The meetings will be closed to the Cargo Control, Inc., as a Commercial antiatherogenic activities of high-density public in accordance with the Gauger and Laboratory lipoprotein. Circ Res. 2010 Jul provisions set forth in sections AGENCY: U.S. Customs and Border 23;107(2):217–27. [PMID 20508181] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Protection, Department of Homeland 11. Amar MJ, et al. 5A apolipoprotein as amended. The grant applications and mimetic peptide promotes cholesterol Security. the discussions could disclose efflux and reduces atherosclerosis in ACTION: Notice of accreditation and confidential trade secrets or commercial approval of Camin Cargo Control, Inc., mice. J Pharmacol Exp Ther. 2010 property such as patentable material, as a commercial gauger and laboratory. Aug;334(2):634–41. [PMID 20484557] 12. Tabet F, et al. The 5A apolipoprotein A- and personal information concerning I mimetic peptide displays individuals associated with the grant SUMMARY: Notice is hereby given, antiinflammatory and antioxidant applications, the disclosure of which pursuant to CBP regulations, that Camin properties in vivo and in vitro. would constitute a clearly unwarranted Cargo Control, Inc., has been approved Arterioscler Thromb Vasc Biol. 2010 invasion of personal privacy. to gauge and accredited to test Feb;30(2):246–52. [PMID 19965776] petroleum and certain petroleum Name of Committee: National Institute of 13. Sethi AA, et al. Asymmetry in the lipid products for customs purposes for the Child Health and Human Development affinity of bihelical amphipathic next three years as of June 7, 2016. Special Emphasis Panel; NICHD T35 peptides. A structural determinant for Teleconference Review. DATES: Effective Dates: The the specificity of ABCA1–dependent Date: February 6, 2017. accreditation and approval of Camin cholesterol efflux by peptides. J Biol Time: 2:00 p.m. to 3:00 p.m. Cargo Control, Inc., as commercial Chem. 2008 Nov 21;283(47):32273–82. Agenda: To review and evaluate grant [PMID 18805791] gauger and laboratory became effective applications. Intellectual Property: NIH Reference Place: National Institutes of Health, on June 7, 2016. The next triennial No. E–114–2004/0—Issued Patents: Rockledge 6710B, 6701B Rockledge Drive, inspection date will be scheduled for Bethesda, MD 20817 (Telephone Conference June 2019. • US 7,572,771 issued 2009–11–08; • US 8,071,746 issued 2011–12–06; Call). FOR FURTHER INFORMATION CONTACT: • US 8,148,323 issued 2012–04–03; Contact Person: Sherry L. Dupere, Ph.D., Approved Gauger and Accredited • US 8,835,378 issued 2014–09–16; Chief, Scientific Review Branch, Scientific Laboratories Manager, Laboratories and • AU 2005295640 issued 2011–11–10; Review Branch, Eunice Kennedy Shriver Scientific Services Directorate, U.S. National Institute of Child Health and • CA 2584048 issued 2016–08–09; Customs and Border Protection, 1300 Human Development, NIH, 6710B Bethesda • EP 1812474 issued 2010–05–26, Pennsylvania Avenue NW., Suite Drive, 2221A, Bethesda, MD 20892, 301– validated in CH, DE, ES, FR, GB and 451–3415, duperes@mail.nih.gov. 1500N, Washington, DC 20229, tel. 202– IT; and 344–1060. Name of Committee: National Institute of • JP 5,091,679 issued 2012–09–21. Child Health and Human Development SUPPLEMENTARY INFORMATION: Notice is Licensing Contact: Cristina Special Emphasis Panel; NICHD Consortium hereby given pursuant to 19 CFR 151.12 Thalhammer-Reyero, Ph.D., M.B.A.; for Research on Pediatric Trauma and Injury and 19 CFR 151.13, that Camin Cargo 301–435–4507; thalhamc@mail.nih.gov. Prevention (R24). Control, Inc., 3001 SW. 3rd Ave., Suite Collaborative Research Opportunity: Date: April 10, 2017. #8, Fort Lauderdale, FL 33315, has been The National Heart, Lung, and Blood Time: 8:00 a.m. to 5:00 p.m. approved to gauge and accredited to test Institute is seeking statements of Agenda: To review and evaluate grant applications. petroleum and certain petroleum capability or interest from parties Place: Embassy Suites at the Chevy Chase products for customs purposes, in interested in collaborative research to Pavilion, 4300 Military Road NW., accordance with the provisions of 19 further develop, evaluate or Washington, DC 20015. CFR 151.12 and 19 CFR 151.13. Camin commercialize ApoA–1 mimetic Contact Person: Joanna Kubler-Kielb, Cargo Control, Inc., is approved for the peptides. For collaboration Scientific Review Officer, Scientific Review following gauging procedures for opportunities, please contact Denise Branch, Eunice Kennedy Shriver National petroleum and certain petroleum Crooks, Ph.D. at 301–435–0103 or Institute of Child Health and Human products set forth by the American crooksd@nhlbi.nih.gov. Development, 6710B Bethesda Drive, Petroleum Institute (API): Dated: November 30, 2016. Bethesda, MD 20892, 301–435–6916, kielbj@ mstockstill on DSK3G9T082PROD with NOTICES mail.nih.gov. Cristina Thalhammer-Reyero, API chapters Title (Catalogue of Federal Domestic Assistance Senior Licensing and Patenting Manager, Program Nos. 93.864, Population Research; 3 ................... Tank gauging. Office of Technology Transfer and 7 ................... Temperature Determination. 93.865, Research for Mothers and Children; Development, National Heart, Lung, and 8 ................... Sampling. 93.929, Center for Medical Rehabilitation Blood Institute. 9 ................... Density Determination. Research; 93.209, Contraception and [FR Doc. 2016–29151 Filed 12–5–16; 8:45 am] 12 ................. Calculations. Infertility Loan Repayment Program, National 17 ................. Maritime Measurements. BILLING CODE 4140–01–P Institutes of Health, HHS) VerDate Sep<11>2014 17:39 Dec 05, 2016 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1


Document Created: 2016-12-06 02:18:53
Document Modified: 2016-12-06 02:18:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLicensing 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.
FR Citation81 FR 87942 
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