Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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.

Strand-Specific Amplification

Vinay K. Pathak, David C. Thomas (NCI)

DHHS Reference No. E-018-2004/0-US-01 filed 04 Dec 2003

Licensing Contact: Michael Ambrose; 301/594-6565; ambrosem@mail.nih.gov.

Replication of genetic material for all organisms involves synthesis of different strands of nucleic acid. In addition, replication of these strands requires the coordinated effort of several proteins and as such, are potential targets for drug therapy. In HIV infection, the potential for drug therapy targeted to specific steps in viral replication is advantageous as it might enable the therapeutic intervention to be more efficient and specific to the viral replication.

This technology enables the researcher to evaluate the effects novel therapies and therapeutic protocols have on viral replication by assessing the impact of therapy on specific steps in viral replication. The technology involves using padlock probes that attached at the 5' and 3' ends and ligate together forming a circle. The circle is then amplified using the rolling amplification technique. The amplified circles can be detected and quantitated using real-time PCR for assessment.

The technology can be used in the development of test kits for prognostics and therapeutic evaluation as well as assessing the effects and efficacy of new and novel therapeutics for HIV infection.

A Novel Approach to Genome-Wide Identification of Gene Regulatory Sequences

Gregory E. Crawford (NHGRI).

U.S. Provisional Application 60/511,905 filed 15 Oct 2003 (DHHS Reference No. E-286-2003/0-US-01)

Licensing Contact: Fatima Sayyid; (301) 435-4521; sayyidf@mail.nih.gov

Sequence analysis of the human genome has identified approximately 30,000 protein-coding genes, but little is known about how most of these genes are regulated. A major goal of current genome research is to identify the location of all cis-acting gene regulatory elements for all genes. This will be necessary if we are to understand global gene regulation in different tissues as well as identify regulatory variants that make individuals more susceptible to common diseases.

The present invention relates to methods of studying gene regulatory elements on a genome-wide scale. Particularly, it relates to methods of generating libraries of DNAse hypersensitive genomic sequences, which are believed to correlate well with the locations of gene regulatory elements. These methods involve obtaining nuclei from the cell sample, subjecting the nuclei to DNAse I digestion, and embedding the DNAsed sample in low melt agarose to substantially prevent non-specific shearing of the genomic DNA. The DNAsed fragments are then blunted and further processed, to permit isolation and analysis of the putative regulatory elements.

Retrovirus-Like Particles and Retroviral Vaccines

David E. Ott (NCI)

PCT Application filed 27 Oct 2003 (DHHS Reference No. E-236-2003/0-PCT-01)

Licensing Contact: Susan Ano; (301) 435-5515; anos@mail.nih.gov

This technology describes retrovirus-like particles and their production from retroviral constructs in which the gene encoding all but seven amino acids of the nucleocapsid (NC) protein was deleted. This deletion functionally eliminates packaging of the genomic RNA, thus resulting in non-infectious retrovirus-like particles. These particles can be used in vaccines or immunogenic compositions. Specific examples using HIV-1 constructs are given. Furthermore, efficient formation of these particles requires inhibition of the protease enzymatic activity, either by mutation to the protease gene in the construct or by protease inhibitor thereby ensuring the production of non-infectious retrovirus-like particles. This technology is further described in Ott et al., Journal of Virology, 2003, 77(5), 5547.

Aerosolized Capreomycin for Inhibition of Pulmonary Tuberculosis

Carl N. Kraus, Clifton E. Barry III, Bernard Doan (NIAID)

U.S. Provisional Application No. 60/500,001 filed 11 Sep 2002 (DHHS Reference No. E-286-2002/0-US-01).

Licensing Contact: Michael Ambrose; (301) 594-6565; ambrosem@mail.nih.gov.

This technology involves the methods of reformulation of Capreomycin for the aerosol treatment of pulmonary tuberculosis.

Tuberculosis is a devastating lung disease that is highly infectious and easily transmitted, especially in areas of overcrowding such as prisons. Furthermore, underdeveloped countries with large populations living in close quarters maintain an endemic disease reservoir limiting the health and economic viability of the population. The WHO estimates that as many as 1/3 of the population may be infected. Current treatment requires the patient to take medication over an extended period of time, up to 12 months or more in some cases. This leads to clinical failure and the potential development of multi-drug resistant strains. Resistant strains of tuberculosis further tax the health care delivery as second line anti-tubercular therapies are more likely to have side effects yet still require long-term adherence to therapy regimens.

The disclosed technology provides for the delivery of Capreomycin in an aerosol formulation. This provides for ease of delivery in both first and second line tuberculosis regimens. Furthermore, the aerosol formulation does not require extensive training of health-care workers to administer the therapy, minimizing the need for added personnel in underdeveloped countries. This, along with the increased product stability will enhance patient adherence to therapy and the potential reduction of disease burden, both for the patient and the population.