[Federal Register Volume 75, Number 158 (Tuesday, August 17, 2010)]
[Notices]
[Pages 50767-50768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20277]


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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.

Glioblastoma Diagnostics and Therapeutics

    Description of Invention: Investigators at the NIH have discovered 
an Anti-TNF Induced Apoptosis (ATIA) protein, which protects cells 
against apoptosis. ATIA is highly expressed in glioblastoma and 
astrocytomas and its inhibition results in increased cell sensitivity 
to TNF-related apoptosis-inducing ligand induced cell death. Hence, 
ATIA assays may enable clinicians to effectively stratify patients for 
appropriate treatment. ATIA exists in a soluble form that can be 
detected in culture medium of ATIA expressing cells indicating it could 
be used to develop a non-invasive, blood based diagnostic test such as 
an ELISA. Glioblastomas and astrocytomas can be diagnosed via MRI and 
CT scans; however, these scans cannot detect tumor type, i.e. 
glioblastoma vs. medulloblastoma. The investigators found that ATIA is 
induced in cells under hypoxia conditions. More importantly, knockdown 
of ATIA in human glioblastoma cells renders cells to apoptosis under 
hypoxia conditions. Therefore, ATIA is a potential novel therapeutic 
target for treating human glioblastoma.
    Glioblastoma arise from astrocytes, cells that provide neurons 
structural and metabolic support. Glioblastomas

[[Page 50768]]

account for twenty percent of primary brain tumors and fifty percent of 
astrocytomas. These indications are designated as rare diseases as 
there is an annual 2-3 newly diagnosed cases of glioblastoma per 
100,000 people in the United States whereas the astrocytoma incidence 
rate is 1.22 cases per 100,000 for individuals aged 0-19 years in the 
United States.
    Applications:
     Blood based diagnostic assays.
     Assay for clinicians to choose effective treatments.
     Therapy to treat human glioblastoma.
    Advantages:
     Non-invasive diagnostics.
     Easy, ready to use assays.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market: Brain cancer market was worth an estimated $1,094 million 
in 2009 and expected to reach $1.3 billion by 2016.
    Inventor: Zheng-gang Liu (NCI).
    Patent Status: PCT Patent Application No. PCT/US2010/36394 filed 27 
May 2010 (HHS Reference No. E-178-2009/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Cell and Cancer Biology Branch, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology. Please contact 
John Hewes, Ph.D. at 301-435-3131 or [email protected] for more 
information.

Inflammatory Genes and MicroRNA-21 as Biomarkers for Colon Cancer 
Prognosis

    Description of Invention: Colon adenocarcinoma is the leading cause 
of cancer mortality world-wide and accounts for approximately 50,000 
deaths annually in the United States. Adjuvant therapies improve 
survival for stage III colon cancer patients; however, it remains 
controversial if stage II patients should be given these therapies. 
Some stage II patients will benefit from therapy (such as patients with 
undetectable micro-metastases where surgery will not be curative); but 
therapy for others will harm quality of life with little therapeutic 
benefit (such as patients where surgery removed all cancerous tissue 
and therefore do not need additional therapy). Thus, there is a need to 
for biomarkers capable of accurately identifying high risk, stage II 
patients that are suitable for therapeutic intervention.
    The investigators have identified an inflammatory gene and microRNA 
biomarker portfolio that can predict aggressive colon cancer, colon 
cancer patient survival, and patients that are candidates for adjuvant 
therapy. These biomarkers provide clinicians with a powerful tool to 
diagnose colon cancer patients and chose effective treatment methods.
    Applications:
     Method to predict aggressive form of colon cancer, 
especially in stage II cancer patients.
     Method to determine appropriate colon cancer patients for 
adjuvant therapy.
     Diagnostic arrays.
    Advantages:
     Rapid, easy to use arrays to accurately predict colon 
cancer and patients suitable for adjuvant therapy.
     Method to stratify colon cancer patients for adjuvant 
therapy to minimize negative side effects.
     Method to identify stage II patients that are likely to 
have undetectable micro-metastases.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     Global cancer market is worth more than eight percent of 
total global pharmaceutical sales.
     Cancer industry is predicted to expand to $85.3 billion by 
2010.
    Inventors: Curtis C. Harris and Aaron J. Schetter (NCI).
    Relevant Publication: AJ Schetter et al. MicroRNA expression 
profiles associated with prognosis and therapeutic outcome in colon 
adenocarcinoma. JAMA. 2008 Jan 30;299(4):425-436. [PubMed: 18230780].
    Patent Status: PCT Application No. PCT/US09/058425 filed 25 Sep 
2009, which published as WO/2010/036924 on 01 Apr 2010 (HHS Reference 
No. E-314-2008/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The NCI Laboratory of Human. 
Carcinogenesis is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize cancer biomarkers and therapeutic targets. 
Please contact [email protected] for more information.

    Dated: August 11, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-20277 Filed 8-16-10; 8:45 am]
BILLING CODE 4140-01-P