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Government-Owned Inventions; Availability for Licensing

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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.

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 Start Printed Page 50768account 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; wongje@mail.nih.gov.

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 hewesj@mail.nih.gov 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; wongje@mail.nih.gov.

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 Curtis_Harris@nih.gov for more information.

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Dated: August 11, 2010.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 2010-20277 Filed 8-16-10; 8:45 am]

BILLING CODE 4140-01-P