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59 FR (05/17/1994) » 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
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]
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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
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