[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: ps193c@nih.gov.
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: mm25q@nih.gov. 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
