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###### Department of Health and Human Services

###### National Institutes of Health 

# AGENCY:

National Institutes of Health, Public Health Service, HHS. 

# ACTION:

Notice. 

# 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: Fatima.Sayyid@nih.hhs.gov.*

# 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,                           ( print 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