[Federal Register Volume 75, Number 90 (Tuesday, May 11, 2010)]
[Notices]
[Pages 26258-26260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11173]


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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.

Erythroid Progenitor Cell Line for Hematological Disease Applications

    Description of Invention: Plasmodium vivax (malaria) is a 
significant health concern in many parts of Asia, Latin America, North 
Africa, and the Middle East. There is a lack of continuous culture 
systems for this pathogen. The subject technology is an erythroid 
progenitor continuous cell line (termed CD36E) identified by erythroid 
markers CD36, CD33, CD44, CD71, CD235, and globoside. These CD36E cells 
are heterozygous for Fya and Fyb (Duffy antigen). Due to recent 
evidence that Plasmodium vivax (P. vivax) can infect erythroid 
progenitor cells (reference: YX Ru et al. and T Panichakul et al.), 
these cells can be potentially used for culturing P. vivax and other 
species of malaria. This in turn could aid development of malaria 
related treatments and/or products. In addition, the cell line can also 
be used for other hematological disease applications that involve red 
blood cells or red blood cell precursors. The CD36E cells also produce 
alpha, beta, and chi hemoglobin and therefore may be used for research 
involving hemoglobin.
    Applications:
    <bullet> Culture system for Plasmodium species (malaria)
    <bullet> Hematological diseases
    Advantages: Immortalized erythroid progenitor cell line.
    Development Status: In vitro data can be provided upon request.
    Market:
    <bullet> Malaria
    <bullet> Anti-malaria drug screening
    <bullet> Hematological diseases
    <bullet> Hemoglobin
    Inventors: Susan Wong, Neal S. Young, Ning Zhi (NHLBI).
    Relevant Publications:
    1. YX Ru et al. Invasion of erythroblasts by Pasmodium vivax: A new 
mechanism contributing to malarial anemia. Ultrastruct Pathol. 2009 
Oct;33(5):236-242. [PubMed: 19895296].
    2. T Panichakul et al. Production of erythropoietic cells in vitro 
for continuous culture of Plasmodium vivax. Int J Parasitol. 2007 
Dec;37(14):1551-1557. [PubMed: 17610880].
    Patent Status: HHS Reference No. E-151-2010/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for biological materials licensing.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
<a href="/cdn-cgi/l/email-protection#4c2f242d222b27290c212d252062222524622b233a"><span class="__cf_email__" data-cfemail="65060d040b020e002508040c094b0b0c0d4b020a13">[email protected]</span></a>.
    Collaborative Research Opportunity: The National Heart Lung and 
Blood Institute, Hematology Branch, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize the CD36E cell line. Please 
contact Cecilia Pazman, Ph.D., at <a href="/cdn-cgi/l/email-protection#a2d2c3d8cfc3ccc1c7e2cfc3cbce8ccccbca8cc5cdd4"><span class="__cf_email__" data-cfemail="5424352e39353a37311439353d387a3a3d3c7a333b22">[email protected]</span></a> for more 
information.

Parvovirus B19 Codon Optimized Structural Proteins for Vaccine and 
Diagnostic Applications

    Description of Invention: Parvovirus B19 (B19V) is the only known 
pathogenic human parvovirus. Infection by this viral pathogen can cause 
transient aplastic crisis in individuals with high red cell turnover, 
pure red cell aplasia in immunosuppressed patients, and hydrops fetalis 
during

[[Page 26259]]

pregnancy. In children, B19V most commonly causes erythema infectiosum, 
or fifth's disease. Infection can also cause arthropathy and 
arthralgia. The virus is very erythrotropic, targeting human erythroid 
(red blood) progenitors found in the blood, bone marrow, and fetal 
liver. Currently, there are no approved vaccines or antiviral drugs for 
the treatment or prevention of B19V infection.
    The subject technology is a series of plasmid constructs with codon 
optimized B19 viral capsid genes (VP1 and VP2) that can be expressed in 
mammalian cells. Transfection of vectors encoding these optimized VP1 
and VP2 genes into different mammalian cell lines, including 293, Cos7, 
and Hela cells produce virus-like particles (VLPs). The vectors include 
bicistronic plasmids expressing the VP1 and VP2 proteins at different 
ratios to produce B19V VLPs with optimal antigenicity for vaccine 
applications. This technology can also be used for diagnostic 
applications and development of a viral packaging system for producing 
infectious B19V virus.
    Applications:
    <bullet> VLPs based vaccines for the prevention and/or treatment of 
B19V infection
    <bullet> DNA based vaccines for the prevention and/or treatment of 
B19V infection
    <bullet> B19V diagnostics
    <bullet> Viral packaging system
    Advantages:
    <bullet> Codon optimized VP1 and VP2 genes for better expression in 
mammalian cell lines
    <bullet> Expression of B19V VLPs from ``nonpermissive'' cell lines
    Development Status: In vitro data can be provided upon request.
    Market:
    <bullet> B19V vaccines (VLPs and DNA)
    <bullet> B19V diagnostics
    Inventors: Ning Zhi, Sachiko Kajigaya, and Neal S. Young (NHLBI).
    Patent Status: U.S. Provisional Application No. 61/337,983 filed 12 
Feb 2010 (HHS Reference No. E-011-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
<a href="/cdn-cgi/l/email-protection#bbd8d3dad5dcd0defbd6dad2d795d5d2d395dcd4cd"><span class="__cf_email__" data-cfemail="a9cac1c8c7cec2cce9c4c8c0c587c7c0c187cec6df">[email protected]</span></a>.
    Collaborative Research Opportunity: The National Heart Lung and 
Blood Institute, Hematology Branch, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize the subject technology. 
Please contact Cecilia Pazman, Ph.D., at <a href="/cdn-cgi/l/email-protection#d4a4b5aeb9b5bab7b194b9b5bdb8fababdbcfab3bba2"><span class="__cf_email__" data-cfemail="d7a7b6adbab6b9b4b297bab6bebbf9b9bebff9b0b8a1">[email protected]</span></a> for more 
information.

Optimized Expression of IL-12 Cytokine Family

    Description of Invention: The IL-12 family of cytokines (IL-12, IL-
23, and IL-27) has an important role in inflammation and autoimmune 
diseases. IL-12 is produced by macrophages and dendritic cells in 
response to certain bacterial and parasitic infections and is a 
powerful inducer of IFN-gamma production. IL-23 is proposed to 
stimulate a subset of T cells to produce IL-17, which in turn induce 
the production of proinflammatory cytokines that lead to a protective 
response during infection. IL-27 appears to have duel functions as an 
initiator of TH1-type (cellular immunity) immune responses and as an 
attenuator of immune/inflammatory responses.
    The present inventions provide methods for improved expression of 
multimeric proteins by engineering different ratios of the subunit 
expression units in a cell or upon expression from a multi-promoter 
plasmid having different strength promoters. The inventors have 
improved the levels and efficiency of expression of the IL-12 family of 
cytokines, which includes IL-12, IL-23, and IL-27, by adjusting the 
transcription and translation of the alpha and beta subunits that 
comprise the heterodimeric proteins. Optimal ratios of expression for 
the two (2) subunits were determined for IL-12, IL-23, and IL-27.
    Applications:
    <bullet> Tumor treatment
    <bullet> Anti-viral therapy
    <bullet> Anti-inflammatory therapy
    Advantages: Increased expression and stability of in vitro 
expressed IL-12, IL-23 and IL-27 cytokines
    Development Status: In vitro data and data in animal models can be 
provided upon request
    Market:
    <bullet> Infectious Diseases
    <bullet> Cancer
    <bullet> Inflammatory Diseases
    Inventors: George N. Pavlakis and Barbara K. Felber (NCI)
    Patent Status: International PCT Patent Application No. PCT/US09/
043481 filed 11 May 2009, which published as WO 2009/140206 on 19 Nov 
2009 (HHS Reference No. E-192-2008/1-PCT-02)
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
<a href="/cdn-cgi/l/email-protection#503338313e373b35103d31393c7e3e39387e373f26"><span class="__cf_email__" data-cfemail="e98a8188878e828ca984888085c7878081c78e869f">[email protected]</span></a>.
    Collaborative Research Opportunity: The Center for Cancer Research, 
Human Retrovirus Section, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize delivery of cytokines of the IL-12 
family in cancer and other indications. Please contact John D. Hewes, 
Ph.D. at 301-435-3121 or <a href="/cdn-cgi/l/email-protection#7c14190b190f163c111d151052121514521b130a"><span class="__cf_email__" data-cfemail="85ede0f2e0f6efc5e8e4ece9abebecedabe2eaf3">[email protected]</span></a> for more information.

Radiotracers for Imaging Cannabinoid Sub-Type 1 (CB<INF>1</INF>) 
Receptor

    Description of Invention: The present invention relates to novel 
radiolabeled compounds for imaging cannabinoid sub-type 1 
(CB<INF>1</INF>) receptors in brains of mammals, particularly humans, 
using positron emission tomography (PET) or single photon emission 
computed tomography (SPECT). These radioligands can be used in clinical 
research, diagnostics, or drug discovery and development, in that, they 
permit understanding of the role of CB<INF>1</INF> receptors in 
neuropsychiatric disorders such as Parkinson's disease, Huntington's 
disease, Alzheimer's disease, multiple sclerosis, depression, mood 
disorder, anxiety, schizophrenia, drug addiction, alcohol disorder, 
obesity and anorexia.
    Applications:
    <bullet> In vivo imaging of CB<INF>1</INF> receptor in mammals, 
particularly humans
    <bullet> Diagnostic imaging of CB<INF>1</INF> receptors in subjects 
having a neurological, neuropsychiatric, neurodegenerative or other 
condition and treatment
    <bullet> Pharmaceutical composition
    <bullet> Diagnostic kits
    Advantages: The principal radioligand under the claim is effective 
for imaging CB<INF>1</INF> receptors in vivo with PET.
    Development Status: Primary radioligand has been evaluated in non-
human primates with PET.
    Market: Radioligands may be useful for performing drug occupancy 
studies of CB<INF>1</INF> receptors, and for neuropsychiatric studies 
and investigations with imaging techniques (e.g., PET or SPECT).
    Inventors: Victor W. Pike (NIMH), Sean R. Donohue (NIMH), et al.
    Relevant Publications:
    1. SR Donohue, C Halldin, VW Pike. Synthesis and structure-activity 
relationships (SARs) of 1,5-diarylpyrazole cannabinoid type-1 
(CB<INF>1</INF>) receptor ligands for potential use in molecular 
imaging. Bioorg Med Chem. 2006 Jun 1;14(11):3712-3720. [PubMed: 
16466922].
    2. SR Donohue, VW Pike, SJ Finnema, P Truong, J Andersson, B 
Guly[aacute]s, C Halldin. Discovery and labeling of high affinity 3,4-
diarylpyrazolines as

[[Page 26260]]

candidate radioligands for in vivo imaging of cannabinoid subtype-1 
(CB<INF>1</INF>) receptors. J Med Chem. 2008 Sep 25;51(18):5608-5616. 
[PubMed: 18754613].
    Licensing Status: Available for licensing.
    Licensing Contact: Susan Ano, PhD; 301-435-5515; <a href="/cdn-cgi/l/email-protection#25444b4a566548444c490b4b4c4d0b424a53"><span class="__cf_email__" data-cfemail="385956574b785559515416565150165f574e">[email protected]</span></a>.

    Dated: May 5, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-11173 Filed 5-10-10; 8:45 am]
BILLING CODE 4140-01-P


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