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.

Therapeutic Targeting of CSN5, a Negative Regulator of p53 and p27, in Human Hepatocellular Carcinoma

Description of Technology: Hepatocellular carcinoma (HCC) represents an extremely poor prognostic cancer that remains one of the most common and aggressive malignancies worldwide. Elevated expression of COP9 complex homolog subunit 5 (CSN5) in early HCC indicates that CSN5 is one of the early markers of malignant conversion. COP9 complex homolog subunit 5 (CSN5) is a multifunctional protein that interacts with a variety of proteins and targets p53 for cell degradation.

Available for licensing are CSN5 siRNAs and nucleic acid-lipid siRNA particles as cancer therapies. HCC cells treated with CSN5 siRNAs inhibited HCC progression and increased apoptosis in vitro and in vivo suggesting that CSN5 is an effective target for the development of cancer treatments.

Applications:

• siRNA cancer therapeutics.
• Nucleic acid-lipid siRNA particles for targeted drug delivery.
• Method to treat cancer.

Development Status: Early stage of development.

Market:

• HCC is the most frequent primary malignant tumor of the liver with a world incidence of 1 million new cases per year.
• The global cancer therapeutic market is expected to grow from $23.1 billion in 2004 to $60.6 billion in 2011. The targeted therapy segment is providing the growth of the entire market with an expected compound annual growth rate of 24.1 percent for 2004-2011.

Inventors: Snorri Thorgeirsson (NCI), Yun-Han Lee (NCI), et al.

Patent Status: U.S. Provisional Application No. 61/045,251 filed 15 Apr 2008 (HHS Reference No. E-174-2008/0-US-01).

Publication: JS Lee et al. Classification and prediction of survival in hepatocellular carcinoma by gene expression profiling. Hepatology 2004 Sept;40(3):667-676.

Licensing Status: Available for non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; wongje@mail.nih.gov.

Computer Aided Scoring and Analysis (CASA) for Rapid and Robust Detection of Biological Molecules in Tissue Microarrays

Description of Technology: Tissue Microarray (TMA) technology is a technique that allows tissue samples to be miniaturized and biologically characterized. The results can be stored digitally and analyzed manually for the expression of biological molecules which can permit the diagnosis or prognosis of disease. Despite its practical use, the current method of manually analyzing TMA samples is subjective and lacks the standardization and concordance needed to support consistent interpretation of the results. This leads to a low correlation in the results obtained amongst different laboratories and detection agents.

The current invention, Computer Aided Scoring and Analysis (CASA), provides a means of rapidly and consistently analyzing the expression patterns of biological molecules in large quantities of tissue samples. This software uses novel algorithms which normalize the pixel data obtained from digital images of the samples, statistically determines which biological molecules are diagnostic markers for the disease, and compares these data to normal, as well as diseased or abnormal tissue samples, to diagnose or predict susceptibility to the disease. In some applications, two or more biological molecules can be simultaneously screened or identified using two or more detection agents making the CASA system amenable to methods such as cluster analysis. This type of analysis can not only identify groups of antigens that are associated with a disease, but can also combine this information with characteristics of the patient population, such as age, gender or ethnicity to achieve a predictive output. The CASA system can analyze data from a broad range of detection agents such as antibodies, radionuclides, dyes and quantum dots making it a very attractive tool for high throughput TMA analysis.

The system has already been used successfully for the diagnosis and prognosis of non-small cell lung cancer in tissue samples and can be adapted for use in many diseases where changes in the expression of one or more biological molecules will to be detected.

Applications:

• Large scale diagnosis of tissue expression patterns of biological molecules.
• Rapid, robust tissue diagnosis or prognosis of disease.
• Compatible with wide range of detection agents.

Development Status: Early Stage.

Inventors: Abbas Shakoori and Jin Jen (NCI).

Patent Status: U.S. Provisional Application No. 61/034,868 filed 07 Mar 2008 (HHS Reference No. E-126-2008/0-US-01).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jeffrey A. James, PhD; 301-435-5474; jeffreyja@mail.nih.gov.

Predictive Test for Age-Related Macular Degeneration in Asymptomatic Individuals

Description of Technology: Age-related macular degeneration (ARMD) is the leading cause of severe, irreversible vision loss for those over the age of fifty in the United States and in other developed countries. Thirteen million Americans over the age of forty have ARMD. ARMD is caused by the deterioration of the central area of the retina, or macula, resulting in a loss of central vision. This disease is believed to be a multigenic disorder, and is triggered by environmental factors such as smoking, age or diet in genetically susceptible individuals.

The present invention describes a highly predictive genetic test for universal practical clinical use to identify individuals at increased risk for ARMD. It comprises a rapid, accurate and affordable genetic screen, utilizing DNA microarray technology on a single chip. Sixteen genes are screened for 90 mutations/polymorphisms associated with ARMD, with a high predictive power (up to 92.7%) to identify asymptomatic carriers at risk. Accurate prediction of genetic susceptibility to this disorder will allow interventions to protect at-risk individuals.

Applications:

• Method to diagnose ARMD.
• Diagnostic kit to identify asymptomatic individuals at risk for ARMD.
• Method to identify genetic factors in an affected individual, aiding in the development of a tailored therapeutic plan.
• Provide genetic epidemiologic data to elucidate the role of genetic factors in the progression of the disease.

Advantage: Easy, rapid high-throughput method to diagnose ARMD.

Development Status: This technology requires analytic validation before commercialization.

Market: There are an estimated 15 million cases of age-related macular degeneration in the United States, and 50 million cases worldwide.

Inventors: Cigdem F. Dogulu, Owen M. Rennert, Wai-Yee Chan (NICHD)

Patent Status:

• U.S. Patent Application No. 12/089,694 filed 09 Apr 2008 (HHS Reference No. E-023-2006/0-US-07).
• Australian Patent Application No. 2006311966 filed 02 Nov 2006 (HHS Reference No. E-023-2006/0-AU-03).
• Canadian Patent Application No. 2,627,686 filed 02 Nov 2006 (HHS Reference No. E-023-2006/0-CA-04).
• European Patent Application No. 06836855.4 filed 02 Nov 2006 (HHS Reference No. E-023-2006/0-CA-04).
• Japanese Patent Application No. 2008-539046 filed 01 May 2008 (HHS Reference No. E-023-2006/0-JP-06).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Jennifer Wong; 301-435-4633; wongje@mail.nih.gov.

Collaborative Research Opportunity: The NICHD Section on Clinical Genomics is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Method Evolved for Recognition and Testing of Age-Related Macular Degeneration (MERT-ARMD). Please contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.