[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

[[Page 1124]]

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