94-11904. National Heart, Lung and Blood Institute; Opportunity for a Cooperative Research and Development Agreement (CRADA) for the Development of Adenoviral-Mediated Gene Therapy for the Treatment of Cardiovascular Conditions  

  • [Federal Register Volume 59, Number 94 (Tuesday, May 17, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-11904]
    
    
    [[Page Unknown]]
    
    [Federal Register: May 17, 1994]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    National Institutes of Health
    
     
    
    National Heart, Lung and Blood Institute; Opportunity for a 
    Cooperative Research and Development Agreement (CRADA) for the 
    Development of Adenoviral-Mediated Gene Therapy for the Treatment of 
    Cardiovascular Conditions
    
    AGENCY: National Institutes of Health, PHS, HHS.
    
    ACTION: Notice.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The National Heart, Lung and Blood Institute (NHLBI) of the 
    National Institutes of Health is seeking capability statements from 
    parties interested in entering into a Cooperative Research and 
    Development Agreement (CRADA) on a project to develop adenoviral-
    mediated gene therapy approaches to treating cardiovascular conditions. 
    This project is with the Cardiology Branch, Bethesda, MD. The goal is 
    to use the respective strength of both partners in developing new 
    approaches to two major cardiovascular conditions: (1) Restenosis after 
    angioplasty and (2) stimulation of collateral formation in the 
    myocardium.
        It is estimated that several hundred thousand U.S. patients will 
    undergo angioplasty this year alone and a similar number will have 
    coronary bypass surgery. To date, the major limitation of angioplasty 
    is a narrowing of the blood vessel at the site of balloon dilation. 
    This process, termed restenosis, occurs in one-third to one-half of 
    patients undergoing angioplasty. There appears at present no effective 
    way of determining which patients will suffer from restenosis, nor is 
    there an effective treatment for the condition. NHLBI has demonstrated 
    that adenoviral-mediated gene transfer can efficiently target areas of 
    vascular injury and is interested in pursuing a strategy where 
    potentially therapeutic genes can be delivered via adenoviral vectors 
    to angioplasty lesions.
        NHLBI has also demonstrated that the administration of peptide 
    growth factors can accelerate myocardial angiogenesis and that 
    adenoviral vectors can efficiently transduce the myocardium. In a 
    second area of collaboration, NHLBI wishes to extend these studies to 
    deliver genes encoding known angiogenic factors to the myocardium using 
    adenoviral vectors.
        It is anticipated that the commercial collaborator will be able to 
    provide a knowledge of recombinant adenoviral vector construction. In 
    addition, the collaborator will be expected to have the capacity to 
    produce recombinant adenoviral stocks in sufficient quantity so as to 
    allow for the testing of these concepts on small and/or large animal 
    models. Such studies might ultimately lead to Phase I or II trials of 
    exceptional candidates which the company could handle in possible 
    conjunction with NHLBI. Collaborator will also be expected to 
    contribute funding for supplies and personnel to support this project.
        Capability statements should be submitted to Ms. Mary Jude Jacobs, 
    National Institutes of Health, National Heart, Lung and Blood 
    Institute, 9000 Rockville Pike, Bldg. 31, rm. 5A48, Bethesda, MD 20892.
    
    Dates: Capability statements must be received by NIH on or before June 
    16, 1994.
    
        Dated: April 25, 1994.
    Barbara M. McGarey,
    Deputy Director, Office of Technology Transfer.
    [FR Doc. 94-11904 Filed 5-16-94; 8:45 am]
    BILLING CODE 4140-01-M
    
    
    

Document Information

Published:
05/17/1994
Department:
National Institutes of Health
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-11904
Dates:
Capability statements must be received by NIH on or before June 16, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: May 17, 1994