[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]


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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.

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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