97-335. National Center for Research Resources: Licensing Opportunity and/or Opportunity for a Cooperative Research and Development Agreement (CRADA) for the Development of Technologies and Applications for Spatial and Temporal Control of Gene ...  

  • [Federal Register Volume 62, Number 5 (Wednesday, January 8, 1997)]
    [Notices]
    [Pages 1123-1124]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-335]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    National Institutes of Health
    
    
    National Center for Research Resources: Licensing Opportunity 
    and/or Opportunity for a Cooperative Research and Development Agreement 
    (CRADA) for the Development of Technologies and Applications for 
    Spatial and Temporal Control of Gene Expression Using a Heat Shock 
    Protein Promoter in Combination With Local Heat
    
    AGENCY: National Institutes of Health, PHS, HHS.
    
    ACTION: Notice.
    
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    SUMMARY: The National Center for Research Resources (NCRR) and 
    collaborating institutes of the NIH are seeking CRADA partners and/or 
    licensees for the development of different technologies and 
    applications to provide a safe and efficient introduction of exogenous 
    genes under the control of a heat-sensitive promoter and to assess the 
    efficacy of spatial and temporal control of gene expression using MRI 
    guided FUS. This project is with the In Vivo NMR Research Center, NCRR, 
    in a collaborative study with the National Institute on Aging, the 
    National Heart Lung and Blood Institute, and the National Institute of 
    Dental Research of the National Institutes of Health, Bethesda, 
    Maryland
        The NCRR has applied for patents claiming this core technology. 
    Non-exclusive and/or exclusive licenses for these patents covering core 
    aspects of this project are available (in accordance with 35 U.S.C. 207 
    and 37 CFR Part 404) to interested parties.
    
    DATES: There is no deadline by which license applications or CRADA 
    proposals must be received.
    
    ADDRESSES: CRADA capability statements/proposals and questions about 
    this opportunity should be addressed to Mr. Tom Ingalls, Technology 
    Transfer Specialist, NCRR, Bldg. 12A/Room 4057, Bethesda, Maryland 
    20892-2490; Phone: 301/496-6235.
        Licensing applications and licensing inquiries regarding this 
    technology should be addressed to Mr. Larry Tiffany, Office of 
    Technology Transfer, 6011 Executive Boulevard, Suite 325, Rockville, 
    Maryland 20852-3804; Phone: 301/496-7735, ext. 206; Fax: 301/402-0220.
        Information on the patent and patent applications and pertinent 
    information not yet publicly described can be obtained under a 
    Confidential Disclosure Agreement. Respondees interested in licensing 
    the invention(s) will be required to submit an Application for License 
    to Public Health Service Inventions. Respondees interested in 
    submitting a CRADA proposal should be aware that it may be necessary to 
    secure a license to the above patent rights in order to commercialize 
    products arising from a CRADA agreement.
    
    SUPPLEMENTARY INFORMATION: In many instances, it is desirable to 
    express exogenous genes only in certain tissues, and/or at will at 
    certain times, and/or only to a certain degree. However, current gene 
    transfer and exogenous gene expression protocols do not provide 
    adequate means of simultaneously controlling which cells in a 
    heterogeneous population are transformed and when, where, and to what 
    degree the transferred genes are expressed. Here, we seek to accomplish 
    the spatial and local control of expression of exogenous genes using a 
    heat-inducible promoter (such as the inducible hsp70 promoter) in 
    combination with local heat, preferably provided by Magnetic Resonance 
    Imaging (MRI) guided Focused Ultrasound (FUS).
    
        The goals of this project are to use the respective strengths of 
    both parties to achieve one or more of the following:
        1. Evaluate the feasibility and safety of gene therapy utilizing a 
    range of suitable vectors as a treatment approach to carry out a 
    systemic gene transfer in which the therapeutic gene is under the 
    control of a heat-sensitive promoter showing negligible constitutive 
    expression at normal body temperature.
        2. Evaluate the feasibility of controlling the local and temporal 
    induction of gene expression (pharmacokinetics) using local heat 
    provided by Magnetic Resonance Imaging guided Focused Ultrasound.
        3. Develop and evaluate gene therapy products for use in 
    experimental animal models and for human use based on the above control 
    of expression.
        It is anticipated that the commercial collaborator(s) will 
    participate in ongoing studies on one or more of the research projects 
    involving:
        1. The transfer of genes for various lymphokines into experimental 
    animal
    
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    models based on an adenovirus vector or other vectors. It is highly 
    desirable that the collaborator have the resources to provide new 
    effective vectors for gene transfer.
        2. The modulation of the inducibility of the heat-sensitive 
    promoter using appropriate modifications of the promoter and by using 
    anti-inflammatory or other drugs.
        3. Dosage and toxicity of local production of lymphokines applied 
    to cancer and other diseases.
        4. Initial applications in the field of anticancer therapy, 
    immunomodulatory gene products and angiogenesis.
        The collaborator may also be expected to contribute financial 
    support under this CRADA for supplies and personnel to support these 
    projects.
    
        Dated: December 19, 1996.
    Barbara M. McGarey,
    Deputy Director, Office of Technology Transfer.
    [FR Doc. 97-335 Filed 1-7-97; 8:45 am]
    BILLING CODE 4140-01-M
    
    
    

Document Information

Published:
01/08/1997
Department:
National Institutes of Health
Entry Type:
Notice
Action:
Notice.
Document Number:
97-335
Dates:
There is no deadline by which license applications or CRADA proposals must be received.
Pages:
1123-1124 (2 pages)
PDF File:
97-335.pdf