Justia Regulation Tracker

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[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]               
[Page 56649-56650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no09-63]                         

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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

[[Page 56650]]

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.

Novel Inhibitors of Interleukin-6 for Kaposi Sarcoma Therapy

    Description of Invention: The cancer therapy market is forecast to 
reach $40.9 billion by 2012. With immunosuppressant drugs set for 
phenomenal growth over the next six years, revenues could reach $26.2 
billion by 2014. One market for which there is a significant need for 
new therapies is cancers induced by Kaposi Sarcoma-associated 
Herpesvirus (KSHV).
    Researchers at the National Cancer Institute have identified novel 
nucleic acid sequences that act through a unique mechanism to inhibit 
the expression of interleukin-6 that occurs in cancerous cells 
transformed by KSHV infection and which promotes cancer cell 
proliferation. The researchers have also identified a key protein 
involved in the mechanism which could be inhibited using antibodies.
    These inhibitors are likely to be accepted in the marketplace 
because their unique specificity in mechanism of action gives them a 
distinct advantage over the mechanisms of other existing therapies.
    Applications:
     Therapies for KSHV-induced cancers (Kaposi sarcoma (KS), 
primary effusion lymphoma (PEL)) and multicentric Castleman disease 
(MCD).
     Therapies for KSHV infection.
     Therapies for interleukin-6 associated inflammatory 
diseases.
     Immunosuppression of interleukin-6.
    Advantages:
     Utilizes available small-molecule and antibody 
technologies.
     Targets a key pathway in interleukin-6 production.
     Specificity of mechanism of action may reduce/limit 
potential side-effects.
    Development Status: Pre-clinical.
    Inventors: Zhi-Ming Zheng and Jeong-Gu Kang (NCI).
    Relevant Publication: JG Kang et al. KSHV infection induces IL6 
expression by interrupting microRNA-mediated translational repression. 
Submitted.
    Patent Status: U.S. Provisional Application No. 61/241,678 filed 11 
Sep 2009 (HHS Reference No. E-296-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.
    Collaborative Research Opportunity: The NCI Center for Cancer 
Research, HIV and AIDS Malignancy Branch, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

Prediction of Immune Response Outcomes to Keyhole Limpet Hemocyanin 
(KLH) Treatment

    Description of Invention: Keyhole limpet hemocyanin (KLH) is a 
large, heterogeneous glycosylated protein that is being tested as an 
immunotherapeutic agent to treat bladder cancer. KLH is approved for 
use in parts of Europe and Asia and is in late stage clinical trials in 
the U.S. KLH immunotherapy however only produces a clinical response in 
approximately 40-50% of patients, and currently there is no good method 
to select the subset of patients that will respond best to this 
treatment. This invention revealed that levels of certain serum 
antibodies can be used as biomarkers to predict the magnitude of the 
antibody response to the glycoprotein KLH. The best correlations are 
obtained by using a combination of markers. Since the size of the 
antibody response correlates with the clinical response, the invention 
provides a method to select the subset of patients that may benefit 
most from this form of treatment.
    Applications and Market:
     It is estimated that 70,980 men and women will be 
diagnosed with and 14,330 men and women will die of cancer of the 
urinary bladder in 2009;
     Biomarkers for immune response outcomes to keyhole limpet 
hemocyanin (KLH);
     Patient selection based on prediction of response.
    Development Status: Pre-clinical stage of development.
    Inventors: Jeffrey C. Gildersleeve and Oyindasola Oyelaran (NCI).
    Publications: Manuscript accepted, Proteomics--Clinical 
Applications.
    Patent Status: U.S. Provisional Application No. 61/243,849 filed 18 
Sep 2009, (HHS Reference No. E-295-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
tongb@mail.nih.gov.
    Collaborative Research Opportunity: The NCI Center for Cancer 
Research, Laboratory of Medicinal Chemistry, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a set of serum 
antibody-based biomarkers for personalized cancer immunotherapy using 
keyhole limpet hemocyanin (KLH). Please contact John D. Hewes, Ph.D. at 
301-435-3121 or hewesj@mail.nih.gov for more information.

    Dated: October 26, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-26313 Filed 10-30-09; 8:45 am]

BILLING CODE 4140-01-P