[Federal Register: May 9, 2006 (Volume 71, Number 89)]
[Notices]
[Page 26977-26978]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my06-103]
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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.
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;
thalhamc@mail.nih.gov.
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; sayyidf@mail.nih.gov.
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.
[[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 gunash@mail.nih.gov 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; clousetp@mail.nih.gov.
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; boodenm@mail.nih.gov.
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.
Dated: May 2, 2005.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-6987 Filed 5-8-06; 8:45 am]
BILLING CODE 4167-01-P