```

[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Notices]
[Pages 14569-14570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7213]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

Vaccine for Shigella sonnei

    Description of Technology: Shigellosis, an inflammatory enteric 
infection is on the World Health Organization's priority list of 
disease to be prevented. It can be prevented by O-specific 
polysaccharide (O-SP)-protein conjugate vaccines in adults. But the 
highest incidence and severity of S. sonnei shigellosis is in young 
children and the O-SP-protein conjugate that was effective in adults 
cannot overcome the age-related immunogenicity of vaccines in this age 
group. Thus, a better immunogen is needed.
    The immunogen claimed in this application uses O-SP formed by 
isolation of low molecular mass of O-SP-core fragments from the native 
product that allows a conjugate to be formed with a ``sun'' 
configuration as opposed to ``lattice'' type conjugates made 
previously, based on a synthetic saccharide conjugate of S. dysenteriae 
type 1 that induced significantly higher antibody levels than the 
``lattice'' type conjugate. IgG antibody levels induced in young 
outbred mice with the ``sun'' configuration S. sonnei conjugate were 
higher than conjugates made with the full length O-SP.
    This application claims the vaccine compositions described above, 
methods of making the vaccine compositions of the technology, and 
methods of preventing and/or treating Shigellosis.
    Application: Development of Shigella sonnei vaccines and 
diagnostics.
    Advantages: Known regulatory path for conjugate vaccines, potential 
reduction in number of doses of vaccine, pediatric vaccine.
    Development Status: Vaccine candidates have been synthesized and 
preclinical studies have been performed.
    Inventors: John B. Robbins (NICHD), Rachel Schneerson (NICHD), 
Joanna Kubler-Kielb (NICHD), Christopher P. Mocca (NICHD), et al.
    Publications:
    1. J Kubler-Kielb et al. The elucidation of the structure of the 
core part of the LPS from Plesiomonas shigelloides serotype O17 
expressing O-polysaccharide chain identical to the Shigella sonnei O-
chain. Carbohydr Res. 2008 Dec 8;343(18):3123-3127.
    2. JB Robbins et al. Shigella sonnei O-specific oligosaccharide-
core-protein conjugates: synthesis, characterization and immunogenicity 
in mice. Proc Natl Acad Sci. 2009; doi 10.1073/pnas.0900891106.
    Patent Status: U.S. Provisional Application No. 61/089,394 filed 15 
Aug 2008 (HHS Reference No. E-308-2008/0-US-01)

[[Page 14570]]

    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected]

Radiotracers for Imaging P-glycoprotein Transporter Function

    Description of Technology: This invention offers technology to help 
treat certain brain diseases, such as Alzheimer's disease and 
Parkinson's, and may lead to more effective and personalized 
treatments. P-glycoprotein transporter (P-gp) acts as a pump at the 
blood-brain barrier to exclude a wide range of xenobiotics (e.g., 
toxins, drugs, etc.) from the brain and is also expressed in a tumor in 
response to exposure to established/prospective chemotherapeutics (a 
phenomenon known as multidrug resistance; MDR). The instant invention 
relates to compounds that are avid substrates for P-gp, and their 
preparation and use as radiotracers for imaging P-gp function in vitro 
and in vivo.
    Applications: These radiotracers have potential application for 
investigating the function of P-gp at the blood-brain barrier for human 
subjects and patients in relation to neuropsychiatric disorders and in 
cancer. Their application may lead to a better general understanding of 
the role of P-gp in the unfolding of certain brain diseases (e.g., 
Alzheimer's disease, Parkinson's disease), and ultimately to more 
effective and personalized treatment. Likewise, these radiotracers may 
be applied in oncology to help understand MDR and its clinical 
manifestation, and to help seek out cancer therapies that avoid MDR.
    Advantages: This class of radiotracer, typified by the described 
[\11\ C]dLop, is designed to restrict the formation of radiometabolites 
that would obstruct the measurement of P-gp function at the blood-brain 
barrier or at tumors. In this sense these radiotracers are vastly 
superior to progenitors (e.g., [\11\ C]verapamil, [\11\ C]loperamide), 
which can only give qualitative not quantitative information.
    Development Status: Radiotracer studies in human subjects are in 
progress. Longer-lived versions of the radiotracers are in development.
    Market: These radiotracers may be of interest to those wishing to 
market and/or apply such radiotracers in the medical imaging field.
    Inventors: Victor W. Pike, Robert B. Innis, Sami S. Zoghbi, and 
Neva Lazarova (NIMH).
    Publications:
    1. SS Zoghbi, JS Liow, F Yasuno, J Hong, E Tuan, N Lazarova, RL 
Gladding, VW Pike, RB Innis. \11\ C-Loperamide and its N-desmethyl 
radiometabolite are avid substrates for brain P-glycoprotein efflux. J 
Nucl Med. 2008 Apr;49(4):649-656.
    2. N Lazarova, SS Zoghbi, J Hong, N Seneca, E Tuan; RL Gladding, JS 
Liow, A Taku, RB Innis, VW Pike. Synthesis and evaluation of [N-methyl-
\11\ C]N-desmethyl-loperamide as a new and improved PET radiotracer for 
imaging P-gp function. J Med Chem. 2008 Oct 9;51(19):6034-6043.
    3. JS Liow, W Kreisl, SS Zoghbi, N Lazarova, N Seneca, RL Gladding, 
A Taku, P Herscovitch, VW Pike, RB Innis. P-glycoprotein function at 
the blood-brain barrier imaged using \11\ C-N-desmethyl-loperamide in 
monkeys. J Nucl Med. 2009 Jan;50(1):108-115.
    Patent Status: U.S. Patent Application No. 12/112,994 filed 30 Apr 
2008 (HHS Reference No. E-318-2007/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Mental Health Molecular Imaging Branch is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize radiotracers 
for imaging P-gp function. Please contact Victor Pike at 
[email protected] for more information.

    Dated: March 24, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-7213 Filed 3-30-09; 8:45 am]
BILLING CODE 4140-01-P
```