[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24832-24833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Peptides Useful in the 
Treatment of Dyslipidemic and Vascular Disorders

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

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, is contemplating the grant of 
an exclusive license worldwide to practice the invention embodied in 
Provisional Patent Application Serial No. 60/619,392 filed 10/15/2004, 
titled ``Multi Domain Amphipathic Helical Peptides and Methods of Their 
Use'' referenced at DHHS as E-114-2004/0-US-01, to Lipid Sciences, 
Inc., having a place of business in the state of California. The field 
of use may be limited to the therapeutic 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 first notice to grant an exclusive license to this 
technology.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before July 11, 
2005 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, Technology Licensing Specialist, 
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 provisional patent application is directed to the 
composition of peptides or peptide analogs with multiple amphipathic 
alpha-helical domains that promote lipid efflux from cells. It further 
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

[[Page 24833]]

disorders. Dyslipidemic and vascular disorders amenable to treatment 
with the isolated multi-domain peptides include, but are not limited 
to, hyperlipidemia, hyperlipoproteinemia, 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: May 4, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-9394 Filed 5-10-05; 8:45 am]
BILLING CODE 4140-01-P