[Federal Register Volume 72, Number 184 (Monday, September 24, 2007)]
[Notices]
[Pages 54270-54272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18774]


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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.

Method for Predicting and Detecting Tumor Metastasis

    Description of Technology: Detecting cancer prior to metastasis 
greatly increases the efficacy of treatment and the chances of patient 
survival. Although numerous biomarkers have been reported to identify 
aggressive tumor types and predict prognosis, each biomarker is 
specific for a particular type of cancer, and no universal marker that 
can predict metastasis in a number of cancers have been identified. In 
addition, due to a lack of reliability, several markers are typically 
required to determine the prognosis and course of therapy.
    Available for licensing are carboxypeptidase E (CPE) inhibitor 
compositions and methods to prognose and treat cancer as well as 
methods to determine the stage of cancer. The inventors discovered that 
CPE expression levels increase according to the presence of cancer and 
metastasis wherein CPE is upregulated in tumors and CPE levels are 
further increased in metastatic cancer. This data has been demonstrated 
both in vitro and in vivo experiments and in liver, breast, prostate, 
colon, and head and neck cancers. Metastatic liver cells treated with 
CPE siRNA reversed the cells from being metastatic and arrested cells 
from further metastasis. Thus, CPE as a biomarker for predicting 
metastasis and its inhibitors have an enormous potential to increase 
patient survival.
    Applications: Method to prognose multiple types of cancer and 
determine likelihood of metastasis; Compositions that inhibit CPE such 
as siRNA; Method to prevent and treat cancer with CPE inhibitors.
    Market: 600,000 cancer related deaths in 2006; 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.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Y. Peng Loh (NICHD) et al.
    Publication: Manuscript in preparation.
    Patent Status: U.S. Provisional Application No. 60/885,809 filed 19 
Jan

[[Page 54271]]

2007 (HHS Reference No. E-096-2007/0-US-01); U.S. Provisional 
Application No. 60/887,061 filed 29 Jan 2007 (HHS Reference No. E-096-
2007/1-US-01); U.S. Provisional Application No. 60/895,912 filed 20 Mar 
2007 (HHS Reference No. E-096-2007/2-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Institute for 
Child Health and Human Development, Section on Cellular Neurobiology, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize CPE as a biomarker for predicting metastasis. Please 
contact John D. Hewes, Ph.D. at 301-435-3121 or [email protected] for 
more information.

Methods of Determining the Prognosis of 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. A major hallmark of 
HCC is intrahepatic metastasis and post-surgical reoccurrence. With 
current diagnostic methods, HCC patients are often diagnosed with end-
stage cancer and have poor survival. Thus, there is a need for an 
accurate method to identify HCC and its proclivity for metastases/
relapse, particularly at early stages of this disease.
    The inventors have discovered a unique set of microRNA (miRNA) 
biomarkers that are associated with HCC metastasis/recurrence. This 
miRNA signature was validated in an independent cohort of 110 HCC 
samples as an independent predictor of HCC prognosis and likelihood of 
metastasis and relapse. In particular, the inventors provide evidence 
that these miRNA markers can predict HCC metastasis in the early stages 
of cancer. This methodology may enable clinicians to effectively 
stratify patients for appropriate cancer treatment and prioritize liver 
transplantation candidates.
    Applications: Method to prognose HCC, patient survival and 
likelihood of HCC metastasis/relapse; Diagnostic tool to aid clinicians 
in determining appropriate cancer treatment; Compositions that inhibit 
miRNA HCC biomarkers such as siRNA; Method to treat HCC patients with 
inhibitory miRNA compositions.
    Market: Primary liver cancer accounts for about 2% of cancers in 
the U.S., but up to half of all cancers in some undeveloped countries; 
Post-operative five year survival rate of HCC patients is 30-40%.
    Development Status: This technology is currently in the pre-
clinical stage of development.
    Inventors: Xin Wei Wang et al. (NCI).
    Publication: Budhu et al. A Unique Metastasis-related MicroRNA 
Expression Signature Predicts Survival and Recurrence in Hepatocellular 
Carcinoma, manuscript in preparation.
    Patent Status: U.S. Provisional Application No. 60/884,052 filed 09 
Jan 2007 (HHS Reference No. E-050-2007/0-US-01).
    Licensing Availability: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

Mutant Alleles of Hsp90 That Modulates the Lifespan of Yeast

    Description of Technology: Heat shock protein 90 (Hsp90) are a 
class of chaperone proteins that are up-regulated in response to 
elevated temperature and other environmental stresses. They act as 
chaperones to other cellular proteins and facilitate their proper 
folding and repair, and aid in the refolding of misfolded client 
proteins.
    This invention identifies Hsp90 mutant residues that affect the 
chronological lifespan of yeast. These mutations in addition to a 
deletion in the sch9 allele, the yeast homolog to human kinase AKT, can 
increase yeast lifespan from 45 to 57 days, approximately 20% longer 
than the wildtype strain. These genetically engineered yeast strains 
may have the longest chronological lifespan reported to date.
    Applications: Model to study aging and longevity factors; Model to 
screen compounds that affect lifespan; A long-lived yeast strain could 
be used to ferment alcohol in a more efficient and cost effective as an 
alternative fuel source; Method to extend lifespan of transgenic farm 
animals.
    Market: Anti-aging and alternative fuel industries are worth 
billions of dollars.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Bradley T. Scroggins (NCI) et al.
    Related Publication: BT Scroggins et al. An acetylation site in the 
middle domain of Hsp90 regulates chaperone function. Mol Cell. 2007 Jan 
12;25(1):151-159.
    Patent Status: U.S. Provisional Application No. 60/848,346 filed 09 
Sep 2006 (HHS Reference No. E-319-2006/0-US-01).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Urologic Oncology Branch is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize models to study aging and longevity 
factors. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

Biomarkers for Tissue Status

    Description of Technology: Tissue regeneration and tumorigenesis 
are complex, adaptive processes controlled by cues from the tissue 
microenvironment. There are complex processes both characterized by 
cell proliferation, migration, and angiogenesis suggesting that wounds 
and cancer share a number of phenotypic similarities including cellular 
behavior, signaling molecules, and gene expression.
    Utilizing the kidneys as a model to compare renal regeneration and 
repair (RRR) from ischemically-injured tissues and renal cellular 
carcinoma (RCC), the inventors have identified biomarkers which are 
differentially expressed. The invention relates to methods of quickly 
and accurately diagnosing RCC and monitoring renal tissue health as 
well as RCC treatment.
    Applications: Method to accurately diagnose RCC; RCC biomarker 
inhibitors such siRNA; Method to treat RCC; Method to determine and 
monitor renal tissue health status; Method for improving renal ischemia 
recovery without promoting RCC; Biomarkers for immunotherapy, drug 
targeting and drug screening, for targeting tumors and not normal 
regenerating tissue; Biomarkers for immunotherapy, drug targeting and 
drug screening, for targeting ischemic tissue and not tumors.
    Market: Kidney cancer is one of the top ten most prevalent cancers 
in the U.S. and it accounts for 12,200 deaths annually; Approximately 
35,000 new cases of kidney cancer are diagnosed annually; 50% survival 
rate after five years of diagnosis; Renal cancer accounts for 3% of all 
adult male malignancies.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Joseph Riss (NCI) et al.
    Publications:

[[Page 54272]]

    1. FF Marshall. Urological Survey. Urological Oncology: Renal, 
Ureteral and Retroperitoneal Tumors. J Urol. 2007 May;177(5):1732-1734.
    2. J Riss et al. Cancers as wounds that do not heal: Differences 
and similarities between renal regeneration/repair and renal cell 
carcinoma. Cancer Res. 2006 July 15;66(14):7216-7224.
    Patent Status: U.S. Provisional Application No. 60/649,208 filed 01 
Feb 2005 (HHS Reference No. E-064-2005/0-US-01); PCT Application No. 
PCT/US2006/003611 filed 01 Feb 2006 (HHS Reference No. E-064-2005/0-
PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Laboratory of Cancer Biology and Genetics, 
Wound Healing and Oncogenesis (NCI/CCR/LCBG), is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize topics of 
invention or related to cancer biology, metastasis, wound healing, 
bioinformatics, pharmacogenomics and therapeutic. Please contact John 
D. Hewes, Ph.D. at 301-435-3121 or [email protected] for more 
information.

    Dated: September 18, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-18774 Filed 9-21-07; 8:45 am]
BILLING CODE 4140-01-P