[Federal Register Volume 74, Number 16 (Tuesday, January 27, 2009)]
[Notices]
[Pages 4756-4757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Multi-Domain Amphipathic 
Helical Peptides for the Treatment of Cardiovascular Diseases

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

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of an exclusive license worldwide to practice the invention 
embodied in: United States Provisional Patent Application No. 60/
619,392, filed October 15, 2004, entitled ``Multi-Domain Amphipathic 
Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-
US-01), United States Patent Application Serial No. 11/577,259, filed 
April 13, 2007, entitled ``Multi-Domain Amphipathic Helical Peptides 
and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-US-07); 
Australian Patent Application Serial No. 2005295640, filed October 14, 
2005, entitled ``Multi-Domain Amphipathic Helical Peptides and Methods 
of Their Use'' (HHS Ref. No. E-114-2004/0-AU-03); Canadian Patent 
Application Serial No. 2584048, filed October 14, 2005, entitled 
``Multi-Domain Amphipathic Helical Peptides and Methods of Their Use'' 
(HHS Ref. No. E-114-2004/0-CA-04); European Patent Application Serial 
No. 05815961.7, filed October 14, 2005, entitled ``Multi-Domain 
Amphipathic Helical Peptides and Methods of Their Use'' (HHS Ref. No. 
E-114-2004/0-EP-05); Japanese Patent Application Serial No. 2007-
536912, filed October 14, 2005, entitled ``Multi-Domain Amphipathic 
Helical Peptides and Methods of Their Use'' (HHS Ref. No. E-114-2004/0-
JP-06) to KineMed, Inc., having a place of business in the State of 
California. The field of use may be limited to FDA or foreign 
regulatory body approved 5a peptide therapeutic for the prevention and 
treatment of cardiovascular diseases. The United States of America is 
the assignee of the patent rights in this invention. The territory may 
be worldwide. This announcement is the second notice to grant an 
exclusive license to this technology and supersedes any previous 
announcements including the Notice published in the Federal Register on 
Wednesday, May 11, 2005 (70 FR 24832).

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
March 30, 2009 will be considered.

ADDRESSES: Requests for a copy of the patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Fatima Sayyid, M.H.P.M., Senior Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4521; Facsimile: (301) 402-0220; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Clearance of excess cholesterol from cells 
by high density lipoproteins (HDL) is facilitated by the interaction of 
HDL apolipoprotein with cell surface binding sites or receptors such as 
ABCA1. ABCA1 is a member of the ATP binding cassette transporter family 
and is expressed by many cell types. Mutations in the ABCA1 transporter 
lead to diseases characterized by the accumulation of excess cellular 
cholesterol, low levels of HDL and an increased risk for cardiovascular 
disease. Research has demonstrated an inverse correlation between the 
occurrence of atherosclerotic events and levels of HDL and its most 
abundant protein constituent, apolipoprotein A-1 (apoA-1). ApoA-1 has 
been shown to promote lipid efflux from ABCA1 transfected cells. 
However, the nature of the interaction between apoA-1 and ABCA1 is not 
fully understood. Several other exchangeable type apolipoproteins have 
been shown to efflux lipid from ABCA1 transfected cells. Although the 
exchangeable type apolipoproteins do not share a similar primary amino 
acid sequence, they all contain amphipathic helices, a structural motif 
known to facilitate the interaction of proteins with lipids. Recently, 
it has been shown in both animal models and humans that intravenous 
administration of apoA-1 can reduce the size of atherosclerotic 
plaques. It has also been observed that synthetic peptide mimics of 
apoA-1 can promote efflux of excess cholesterol from cells. Therefore, 
synthetic mimics of apoA-1 can potentially also be used as therapeutic 
compounds in the prevention and treatment of atherosclerosis.
    Currently, there are a wide variety of treatments for dyslipidemia, 
which include, but are not limited to, pharmacologic regimens (mostly 
statins), partial ileal bypass surgery, portacaval shunt, liver 
transplantation, and removal of atherogenic lipoproteins by one of 
several apheresis procedures.
    The subject technology is related to peptides and peptide analogs 
with multiple amphipathic alpha-helical domains that promote lipid 
efflux from cells and it relates to methods for identifying non-
cytotoxic peptides that promote lipid efflux from cells that are useful 
in the treatment and prevention of dyslipidemic and vascular disorders. 
Dyslipidemic and vascular disorders amenable to treatment with the 
isolated multi-domain peptides include, but are not limited to, 
hyperlipidemia, hyperlipoproteinemia,

[[Page 4757]]

hypercholesterolemia, hypertriglyceridemia, HDL deficiency, apoA-I 
deficiency, coronary artery disease, atherosclerosis, thrombotic 
stroke, peripheral vascular disease, restenosis, acute coronary 
syndrome, and reperfusion myocardial injury.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, NIH receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection, and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: January 21, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E9-1754 Filed 1-26-09; 8:45 am]
BILLING CODE 4140-01-P