[Federal Register Volume 63, Number 230 (Tuesday, December 1, 1998)]
[Notices]
[Pages 66190-66191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31920]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases;
Opportunity for a Cooperative Research and Development Agreement
(CRADA) to Develop Eosinophil-Derived Neutralizing Agent (EDNA) to
Treat Infections in Children and the Elderly Caused by Respiratory
Syncytical Virus and Parainfluenza Virus
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID) of the National Institutes of Health (NIH) is seeking
capability statements from parties interested in entering into a
Cooperative Research and Development Agreement (CRADA) to develop
eosinophil-derived neutralizing agent (EDNA) for the treatment of
infections in children and/or the elderly caused by respiratory
syncytical virus (RSV) and parainfluenza virus (PIV). RSV and PIV are
medically the most important single-stranded enveloped RNA viruses;
infections caused by these viruses hospitalize over 100,000 infants per
year in the U.S.
EDNA is the major eosinophil ribonuclease. Recombinant human EDNA
is envisioned as an agent for direct inhalation therapy in patients
with established RSV or PIV bronchiolitis, in those with a high index
of suspicion, and as prophylactic therapy in children with predisposing
conditions (prematurity, bronchopulmonary, dysplasia, congenital heart
disease, and immunodeficiency).
Recombinant human EDNA has been produced in bacterial and
baculovirus expression systems and is not toxic to respiratory
epithelial cells. ENDA is a soluble and thermostable low molecular
weight protein not requiring demanding conditions for storage or
administration. In vitro experiments have shown it to have potent
antiviral activity against RSV (Domachowske, JB et al. 1998. J. Infect.
Dis. 177:1458-1464). Initial studies in the Balb/C mouse model of RSV
infection support its effectiveness against this virus. This project is
part of the study of ribonucleases and host defense in the Laboratory
of Host Defenses (LHD), Division of Intramural Research, NIAID.
DATES: Only written capability statements received by the NIAID on or
before March 1, 1999 will be considered.
ADDRESSES: Capability statements should be submitted to Dr. Michael R.
Mowatt, Office of Technology Development, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, 31 Center Drive
MSC 2137, Building 31, Room 3B62, Bethesda, MD 20892-2137; Tel: 301/
496-2644, Fax: 301/402-7132; Electronic mail: mmowattanih.gov.
SUPPLEMENTARY INFORMATION:
Under the CRADA the production of biologically active recombinant human
EDNA will be optimized and the agent evaluated in a series of
preclinical studies in animals as well as initial safety testing in
humans. Positive outcomes of these studies will indicate continued
clinical development aimed at supporting regulatory approval of a
product to be labeled for use in children and/or the elderly. The
Public Health Service (PHS) has filed patent applications both in the
U.S. and internationally related to this technology. Notice of the
availability of the patent application for licensing was first
published in the Federal Register (Vol. 62, No. 219, page 60909) on
November 13, 1997.
NIAID's principal investigator has extensive experience with
recombinant technology as applied to ribonucleases, their purification
and testing. The Collaborator in this endeavor is expected to assist
NIAID in evaluating its current system for producing recombinant EDNA
and to develop and optimize an alternative expression system, if
necessary, to manufacture sufficient quantities of the product for
preclinical testing in animals and initial safety studies in humans.
The Collaborator must have experience in the manufacture of recombinant
protein products according to applicable FDA guidelines and Points to
Consider documents to include Good Manufacturing Procedures (GMP). In
addition, it is expected that the Collaborator would provide funds to
supplement the LHD's research budget for the project and to support the
preclinical and initial human testing.
The capability statement should include detailed descriptions of:
(1) Collaborator's expertise in the expression of recombinant proteins,
(2) Collaborator's ability to manufacture sufficient quantities of the
product according to FDA guidelines and Points to Consider documents,
(3) the technical expertise of the Collaborator's principal
investigator and laboratory group in preclinical safety testing (e.g.,
expertise in in vitro and in vivo toxicity and
[[Page 66191]]
pharmacology studies) and initial human safety studies, and (4)
Collaborator's ability to provide adequate funding to support
preclinical and initial human safety studies required for marketing
approval.
Dated: November 17, 1998.
Mark Rohrbaugh,
Director, Office of Technology Development, NIAID.
[FR Doc. 98-31920 Filed 11-30-98; 8:45 am]
BILLING CODE 4140-01-M