[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Pages 33102-33103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases: Licensing 
Opportunity and/or Cooperative Research and Development Agreement 
(``CRADA'') Opportunity; Drug and Method for the Therapeutic Treatment 
of Respiratory Syncytial Virus and Parainfluenza Virus in Children

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 NIH is seeking Licensees and/or capability statements 
from parties to further develop, evaluate, and commercialize 
eosinophil-derived neutralizing agent (EDNA) for the treatment of 
infections in children and/or the elderly caused by Respiratory 
Syncytial Virus (RSV) and parainfluenza virus (PIV). RSV and PIV are 
medically the most important single-stranded RNA viruses; infections 
caused by these viruses hospitalize over 100,000 infants per year in 
the U.S.
    The methods and compositions of this invention provide a means for 
prevention and treatment of infection by enveloped RNA viruses by 
eoxinophil derived neutralizing agent (EDNA), a ribonuclease. EDNA is a 
relatively soluble and thermostable protein, active at low 
concentrations, with no direct toxicity to bronchial epithelial cells, 
making it suitable for inhalation therapy. Parenteral administration is 
also contemplated by this invention.
    EDNA, particularly recombinant EDNA, may be used as an agent for 
direct inhalation therapy in children with established RSV 
bronchiolitis (associated with the development of future respiratory 
disorders such as asthma), in children for which there is a high index 
of suspicion, and as prophylactic therapy in children with predisposing 
conditions such as prematurity, bronchiole pulmonary displasia, 
congential heart disease and immunodeficiency. Similar criteria may be 
applied to the susceptible elderly population.
    Recombinant human EDNA has been produced in bacterial and 
baculovirus expression systems. Furthermore, 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 a part of the study of ribonucleases and 
host defenses in the Laboratory of Host Defenses (LHD), Division of 
Intramural Research, NIAID.
    The invention claimed in DHHS Reference No. E-161-97/1, ``Methods 
for Inactivating Enveloped RNA Virus Particles and Compositions for Use 
Therewith'' (HF Rosenberg, JB Domachowske), PCT/US98/13852 filed July 
2, 1998, is available for exclusive or non-exclusive licensing in 
accordance with 35 U.S.C. 207 and 37 CFR part 404 and/or further 
development under one or more CRADAs in the clinically important 
applications described below in the Supplementary Information section.

ADDRESSES: Questions about licensing opportunities should be addressed 
to Peter Soukas, J.D., Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Telephone: (301) 
496-7056 ext. 268; Facsimile: (301) 402-0220; E-mail: [email protected]. 
Information about Patent Applications and pertinent information not yet 
publicly described can be obtained under the terms of a

[[Page 33103]]

Confidential Disclosure Agreement. Respondents interested in licensing 
the invention will be required to submit an ``Application for License 
to Public Health Service Inventions.''
    Depending upon the mutual interests of the Licensee(s) and the 
NIAID, a CRADA to collaborate to develop EDNA as an anti-RSV 
therapeutic may also be negotiated. Proposals and questions about this 
CRADA opportunity should be addressed to Dr. Michael R. Mowatt, 
Technology Development Manager, Office of Technology Development, 
NIAID, Building 31, Room 3B62, 31 Center Drive, Bethesda, MD 20892-
2137, Telephone: (301) 435-8618; E-mail: [email protected]. Respondents 
interested in submitting a CRADA Proposal should be aware that it may 
be necessary to secure a license to the above-mentioned patent rights 
in order to commercialize products arising from a CRADA.

EFFECTIVE DATE: Respondents interested in licensing the invention will 
be required to submit an ``Application for License to Public Health 
Service Inventions'' on or before September 20, 1999, for priority 
consideration.
    Interested CRADA collaborators must submit a confidential proposal 
summary to the NIAID [attention Dr. Michael Mowatt at the 
aforementioned address' on or before September 20, 1999, for 
consideration. Guidelines for preparing full CRADA proposals will be 
communicated shortly thereafter to all respondents with whom initial 
confidential discussions will have established sufficient mutual 
interest. CRADA and PHS License Applications submitted thereafter may 
be considered if a suitable CRADA collaborator of Licensee(s) has not 
been selected.

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 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: May 24, 1999.
Mark Rohrbaugh,
Director, Office of Technology Development, National Institute of 
Allergy and Infectious Diseases.

    Dated: June 10, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-15638 Filed 6-18-99; 8:45 am]
BILLING CODE 4140-01-M