[Federal Register Volume 75, Number 143 (Tuesday, July 27, 2010)]
[Notices]
[Pages 43992-43993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of Federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Therapeutics for the Treatment and Prevention of Atherosclerosis and 
Cardiovascular Disease

    Description of Invention: This technology consists of peptides and 
peptide-analogues that enhance clearance of excess cholesterol in cells 
and do not exhibit the cytotoxicity that has hampered development of 
similar potential therapeutics.
    Briefly, apolipoprotein A-1 (ApoA-1) promotes cholesterol efflux 
from cells and its concentration is inversely correlated with 
atherosclerotic events. The isolated peptidic component of ApoA-1 that 
acts within the cholesterol secretion pathway is therapeutic towards 
atherosclerosis but exhibits cytotoxic effects. In contrast, our 
inventors have derivatized that ApoA-1 peptide which is both less 
cytotoxic and more active than the underivatized component in initial 
studies. This potential therapeutic is similar to high density 
lipoprotein (HDL) therapy and may complement statin-mediated reduction 
of pro-atherogenic lipoproteins.

Potential Applications

     Treatment and prevention of atherosclerosis.
     Treatment and prevention of cardiovascular disease, 
coronary artery disease, heart attack, stroke and inflammation.
     Therapeutic or preventative coating for a heart or 
vascular implant.
     Alternative to HDL therapy.

Potential Advantages

     Enhanced cytotoxicity profile.
     Enhanced hydrophilicity profile.
     Complements statin-based therapies.
     Oral delivery approaches in development.
    Development Status: Early stage with in vitro proof of concept 
data.
    Market: The CDC indicates that heart attacks account for 26% of 
deaths in the United States of which atherosclerosis is a significant 
contributing factor or cause. Global sales for cardiovascular 
therapeutics are expected to exceed $50b in 2010.
    Inventors: Amar A. Sethi (NHLBI) et al.
    Patent Status: U.S. Provisional Application No. 61/265,291 filed 30 
Nov 2009 (HHS Reference No. E-047-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid. M.H.P.M.; 301-435-4521;
    [email protected].

Use of Immunosuppressive Agents for Treatment of Age-related Macular 
Degeneration (AMD) and Diabetic Retinopathy

    Description of Invention: AMD belongs to a group of disorders in 
which the immune system may play an important role. This invention 
discloses that patients with AMD gain additional therapeutic benefit 
from combination treatment of immunosuppressive agents and standard-of-
care in comparison to standard-of-care alone. This invention slows the 
progression of choroidal neovascularization (CNV) and may have 
implications for related pathologies, including diabetic retinopathy. 
Clinical data from a small, randomized pilot clinical trial are 
available.

Applications

     A method of treatment for AMD.
     A method of treatment for diabetic retinopathy.
     A method of treatment for diseases associated with CNV.

Advantages

     Likely to be synergistic with existing therapeutics.
     May enable repurposing of some exiting immunosuppressive 
agents.

[[Page 43993]]

    Development Status: In clinical trials.
    Market: An estimated three million individuals in the United States 
will have an advanced form of AMD by 2020 (Klein R et al. The 
epidemiology of age-related macular degeneration. Am J Ophthalmol. 
2004;137(3):486-95).
    Inventors: Robert B. Nussenblatt and Frederick L. Ferris (NEI).
    Publication: In preparation.
    Patent Status: U.S. Provisional Application No. 61/254,439 filed 23 
Oct 2009 (HHS Reference No. E-198-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Norbert Pontzer, J.D., PhD; 301-435-5502; 
[email protected].
    Collaborative Research Opportunity: The National Eye Institute, 
Laboratory of Immunology, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the use of immunosuppressive agents 
in the treatment of age related macular degeneration. This is in light 
of new findings that immune mechanisms appear to be central to the 
expression of the clinical disease we know as AMD. Please contact Alan 
Hubbs, PhD at 301-594-4263 or [email protected] for more information.

    Dated: July 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-17446 Filed 7-26-10; 8:45 am]
BILLING CODE 4140-01-M