[Federal Register Volume 72, Number 150 (Monday, August 6, 2007)]
[Notices]
[Pages 43645-43647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15168]


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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

[[Page 43646]]

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.

Methods for Determining Hepatocellular Carcinoma Subtype and Detecting 
Hepatic Cancer Stem Cells

    Description of Technology: Hepatocellular carcinoma (HCC) is the 
third leading cause of cancer death worldwide, and it is very 
heterogeneous in terms of its clinical presentation as well as genomic 
and transcriptomic patterns. HCC can originate from both adult 
hepatocytes and hepatic progenitor cells. The extent of progenitor cell 
activation and the direction of differentiation are correlated with the 
severity of the disease. HCC patient variability indicates that HCC 
comprises several biologically distinct subtypes. This heterogeneity 
and the lack of appropriate biomarkers have hampered patient prognosis 
and treatment stratification.
    Available for licensing are microRNA biomarkers that are associated 
with four HCC subtypes: hepatic stem cell-like, bile duct epithelium-
like, hepatocytic progenitor-like, and mature hepatocyte-like. One 
unique profile is associated with HCC with features of liver stem cells 
and poor patient prognosis. It has both diagnostic and therapeutic 
value in the management of HCC patients.
    Applications: A diagnostic assay where HCC treatment can be 
individualized according to patient HCC subtype; An assay for HCC to 
prognose patient survival; Therapeutic compositions that target subtype 
specific HCC.
    Market: HCC is the third leading cause of cancer death worldwide; 
HCC is the fifth most common cancer in the world; Post-operative five 
year survival rate of HCC patients is 30-40%.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Xin Wei Wang (NCI) et al.
    Publications:
    1. Presented at Keystone Symposia on MicroRNA and Cancer in June 
2007.
    2. R Garzon et al. MicroRNA expression and function in cancer. 
Trends Mol Med. 2006 Dec;12(12):580-587.
    Patent Status: U.S. Provisional Application No. 60/942,833 filed 08 
Jun 2007 (HHS Reference No. E-215-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Human Carcinogenesis, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize this technology. Please 
contact John D. Hewes, Ph.D. at 301-435-3121 or [email protected] for 
more information.

Isolation, Cloning, and Characterization of Novel Adeno-Associated 
Virus Serotypes

    Description of Technology: Adeno-associated viruses (AAV) are used 
in gene delivery, but with limited success due to toxicity. The novel 
AAVs described in this technology may be more effective and useful in 
gene therapy applications.
    This invention relates to new adeno-associated viruses (AAV), 
vectors and particles derived therefrom and also provides methods for 
delivering specific nucleic acids to cells using the AAV vectors and 
particles. The inventors cloned and sequenced the genomes of AAVs found 
in twelve (12) simian adenovirus isolates and determined that the AAVs 
were novel. Ten (10) of these isolates had high similarity to AAV1 and 
AAV6 (>98%). Despite the high homology to AAV6, these novel AAVs 
demonstrated distinct cell tropisms and reactivity towards a panel of 
lectins, suggesting that they may use a distinct entry pathway.
    Applications: AAVs can be used as delivery systems in gene therapy; 
AAV's also have gene transfer applications.
    Advantages: Vectors based on these new AAV serotypes may have a 
different host range and different immunological properties, thus 
allowing for more efficient transduction in certain cell types than 
previously used AAV.
    Benefits: Gene therapy has tremenous potential in treating several 
life threatening diseases, and this technology has the potential to 
benefit millions of patients that could benefit from the proper use of 
gene therapy treatments. Additionally, the gene therapy market is now a 
multi-million dollar industry can substantially benefit from the use of 
this technology.
    A range of licensing opportunities exist, including material 
licenses, commercial licenses, nonexclusive and exclusive licenses, as 
well as fields of use directed towards clinical applications. Please 
see the Office of Technology Transfer website for more information 
(http://www.ott.nih.gov).
    Inventors: Michael Schmidt (NIDCR), John A. Chiorini (NIDCR), et 
al.
    U.S. Patent Status: Pending PCT Application PCT/US2006/017157, 
published as WO 2006/119432 (HHS Reference No. E-179-2005/0-PCT-02).
    Licensing Contact: David A. Lambertson, Ph.D.; Phone: (301) 435-
4632; Fax: (301) 402-0220; E-mail: [email protected].
    Collaborative Research Opportunity: The National Institute of 
Dental and Craniofacial Research, Gene Therapy and Therapeutics Branch, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize adeno-associated viruses. Please contact David W. 
Bradley, Ph.D. at [email protected] for more information.

Serum Autoantibody for Cancer Diagnostics

    Description of Technology: The invention demonstrates that the 
approach of autoantibody analysis provides a valuable approach for 
cancer diagnosis. Detecting serum autoantibodies against extracellular 
form of protein kinase A (ECPKA) can effectively diagnose cancer.
    The technology describes compositions and methods for detecting 
autoantibodies against an ECPKA for the diagnosis of cancer. Because 
ECPKA is secreted from cancer cells at higher rate than normal cells, 
the formation of serum autoantibodies to ECPKA in cancer patients is 
greater. A highly sensitive enzyme immunoassay that measures the 
presence of anti-ECPKA autoantibody in serum of cancer patients can 
therefore be used for cancer diagnosis.
    Application: ECPKA-autoantibody-based immunoassay method provides 
an important diagnostic procedure applicable for the detection of 
various cancers.
    Advantages: Highly sensitive and specific immunoassay developed for 
anti-ECPKA antibody is more sensitive and specific than results from 
other current assays that detect only antigen activity; high 
statistical correlation betweeen the presence of serum-autoantibody 
directed against ECPKA and presence of cancer.
    Benefits: Early detection of cancer and this technology can 
contribute

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significantly to improving the clinical management of cancer and thus 
the quality of life for people suffering from the disease. Furthermore, 
the cancer diagnostic market is estimated to grow to almost $10 billion 
dollars in the next 5 years, providing a significant financial 
opportunity.
    Inventors: Yoon S. Cho-Chung (NCI).
    U.S. Patent Status: U.S. Patent Application No. 10/592,040 (HHS 
Reference No. E-081-2004/2-US-02); Foreign Rights are also available.
    Licensing Contact: David A. Lambertson, Ph.D.; Phone: (301) 435-
4632; Fax: (301) 402-0220; E-mail: [email protected].

A New Series of Thalidomide Analogs That Have Potent Anti-Angiogenic 
Properties

    Description of Technology: This technology describes synthesis of 
several novel tetrahalogenated thalidomide derivatives that are 
potentially more anti-angiogenic than thalidomide. More specifically, 
two series of analogs based on two major common pharmacophores have 
been synthesized. One series preserves the thalidomide common 
structure, while the other series contains a different common structure 
(tetrafluorobenzamides). Several analogs from both series have shown 
significant anti-angiogenic properties, in vitro.
    Applications: The novel thalidomide derivatives have therapeutic 
potential for a broad spectrum of cancer related diseases alone, or in 
combination with existing therapies. The compounds can also be useful 
for the treatment of autoimmune diseases.
    Advantages: Superior anti-angiogenic and anti-cancer activity when 
compared with thalidomide; In vitro data supports use in multiple 
cancer types.
    Benefits: Cancer is the second leading cause of death in the United 
States and it is estimated that there will be approximately 600,000 
deaths caused by cancer in 2007. Improving the quality of life and 
duration of life of cancer patients will depend a lot on chemotherapies 
with reduced toxicity and this technology can contribute significantly 
to that social cause. Furthermore, the technology involving novel anti-
angiogenic small molecule cancer therapy technology has a potential 
market of more than $2 billion.
    Inventors: William D. Figg (NCI) et al.
    U.S. Patent Status: Pending PCT Application PCT/US2007/008849 (HHS 
Reference No. E-080-2006/0-PCT-02).
    Licensing Contact: David A. Lambertson, Ph.D.; Phone: (301) 435-
4632; Fax: (301) 402-0220; E-mail: [email protected].

    Dated: July 30, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-15168 Filed 8-3-07; 8:45 am]
BILLING CODE 4140-01-P