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Government-Owned Inventions; Availability for Licensing

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National Institutes of Health, Public Health Service, HHS.




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.


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.

New Method for Quantification of Allele-Specific RNA Expression, That Can Be Used for Detection of Various Genetic Disorders

Drs. Marjan Huizing, Enriko Klootwijk, Paul Savelkoul, Carla Ciccone, William Gahl (NHGRI)

U.S. Provisional Application No. 60/718,321 filed 20 Sep 2005 (HHS Reference No. E-146-2005/0-US-01)

Licensing Contact: Cristina Thalhammer-Reyero; 301/435-4507;

Available for licensing and commercial development is a new method for quantification of allele-specific RNA expression. This invention describes methods for simultaneously detecting the levels of expression of a plurality of different RNA transcripts expressed from a gene of interest in a subject or a cell. This is a simple assay to validate and quantify allele-specific silencing, by applying a combination of a fluorescent primer/probe set that specifically recognizes the targeted allele where the probe is labeled with one fluorophore, and a primer/probe set that specifically recognizes the normal allele, where the probe is labeled with another fluorophore in the same reaction tube. Furthermore, this method can be run on most real time PCR machines and requires very small amounts of RNA, less than 100 ng. This novel method, by comparing alleles within the same gene, expands on current real time PCR methods which compare one gene with another gene.

The invention also describes methods for validating the effectiveness and specificity of allele-specific siRNAs, kits for performing such assays, as well as methods for diagnosis of autosomal-dominant disorders, in which mutations in one allele result in a disease phenotype, such as Hutchinson-Gilford progeria, incontinentia pigmenti, neurofibromatosis, myotonic dystrophy, sialuria, Machado-Joseph disease, spinocerebellar ataxia, frontotemporal dementia, amyotrophic lateral sclerosis, slow channel congenital myasthenic syndrome, spinobulbar muscular dystrophy, as well as compound heterozygous autosomal recessive disorders. Other diseases that can be diagnosed include diabetes, cystic fibrosis, homocystenuria, Hermansky-Pudlak syndrome, cystinosis, Zellweger syndrome, beta-thalassemia, alkaptonuria, and cancer.

A variety of diseases appear to be mediated or accompanied by aberrant expression of one allele, often a mutant of a gene. Such differences in allelic expression can serve as the basis for diagnostic test for such conditions, and the ability to specifically silence the expression of detrimental alleles could be a therapeutic method for treating the disease, hence this novel method has very wide applications.

Development of Gene Chip Technology for Vascular Risk Assessment

Alison E. Baird (NINDS) et al.

U.S. Provisional Application No. 60/687,515 filed 03 Jun 2005 (HHS Reference No. E-030-2005/0-US-01)

U.S. Provisional Application No. 60/691,730 filed 17 Jun 2005 (HHS Reference No. E-030-2005/1-US-01)

Licensing Contact: Fatima Sayyid; 301/435-4521;

Prevention of cardiovascular disorders such as myocardial infarction and stroke is an area of major public health importance. Currently, several risk factors for future cardiovascular disorders have been described and are in wide clinical use in the detection of individuals at high risk. However a large number of cardiovascular disorders occur in individuals with apparently low to moderate risk profiles, thereby limiting the ability to identify such patients. Moreover, many of the risk factors require accurate gathering of clinical information. An objective panel of biological markers which allow one to predict an individual's risk of vascular disease is therefore needed.

The present provisional patent application is directed to utilizing blood mononuclear cells to evaluate vascular disease risk and determine a preventive regimen for reduction or minimization of such risk. The method includes screening for differential expression of vascular risk-related molecules, such as DNA binding/transcription factor proteins, lysosomal or protein degradation enzymes, adhesion molecules, metabolism molecules, intracellular signaling molecules, immune response molecules and apoptosis. The technology is available to a collaborator for monitoring stroke treatment protocols, for definition of clinical trial protocol candidates, or for developing an “assessment chip” that could be used to predict an individual's risk of developing a stroke in the future. Start Printed Page 26978

The NINDS Stroke Neuroscience Unit is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a vascular risk genetic chip technology. We seek a collaborative partner in the development of a chip that could be used to predict an individual's risk of developing a stroke in the future and to monitor the effectiveness of preventive measures once they have been instituted. Please contact Heather Gunas at for more information.

Method of Inducing Memory B Cell Development and Terminal Differentiation

Peter E. Lipsky (NIAMS) et al.

U.S. Patent Application No. 11/197,221 filed 03 Aug 2005 (HHS Reference No. E-120-2003/2-US-01)

Licensing Contact: Thomas Clouse; 301/435-4076;

Cytokines exert their respective biochemical and physiological effects by binding to specific receptor molecules, which then stimulate signal transduction pathways. Interleukin-21 (1L-21) is a type I cytokine whose receptor is expressed on T, B, and NK cells.

This invention specifically relates to the use of IL-21 to induce differentiation of immature B cells into memory B cells and plasma cells. This invention includes claims of methods for inducing differentiation of a B cell progenitor into memory B cells and/or plasma cells. It also includes claims for enhancing an immune response, treating subjects that lack memory B cells and plasma cells and methods for increasing or decreasing the number of B cells. This invention could conceivably be used in treating or preventing inflammatory disorders, autoimmune diseases, allergies, transplant rejection, cancer, and other immune system disorders.

Immunogenic Epitopes for Fibroblast Growth Factor-5 (FGF-5) Presented by HLA-A3 and HLA-A2

James C. Yang et al. (NCI)

U.S. Patent Application No. 11/134,703 filed 19 May 2005 (HHS Reference No. E-031-2003/1-US-01)

Licensing Contact: Michelle Booden; 301/451-7337;

Approximately 30,000 patients are diagnosed with renal cell carcinoma (RCC) each year in the United States, and an estimated 12,000 patients die of this disease. Most patients are diagnosed with advanced local disease or metastatic disease. Current therapies include removal of the kidney (nephrectomy) or high dose immunotherapy with IL-2, which has been able to achieve success in only part (15-20%) of the patient population. Even with a successful nephrectomy, it is likely that patients with advanced local diseases will develop metastases. Therefore, new methods are needed to improve on IL-2 therapy and expand the curative potential of therapies for patients with RCC.

The present invention discloses peptides for use in immunotherapy of tumors. The peptides, both an HLA-A2 and an HLA-A3 epitope, are derived from the amino acid sequence of an RCC-associated antigen, fibroblast growth factor-5 (FGF-5). Plans are underway to investigate both peptides in clinical trials of peptide vaccination in patients with advanced renal cancer. In addition, FGF-5 also appears to be over-expressed in other common adenocarcinomas such as breast, prostate and bladder cancer and very few antigens suitable for vaccine therapies exist for those cancers.

In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors.

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Dated: May 2, 2005.

David R. Sadowski,

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

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[FR Doc. E6-6987 Filed 5-8-06; 8:45 am]