[Federal Register Volume 63, Number 235 (Tuesday, December 8, 1998)]
[Notices]
[Pages 67696-67697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32491]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Licensing Opportunity and/or Cooperative Research and Development
Agreement (CRADA) Opportunity to Develop a Hepatitis C virus (HCV)
Vaccine Based Upon the Synthesis and Purification of Non-infectious
HCV-like Particles Containing HCV Structural Proteins
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking
licensees and/or capability statements from parties interested in
entering into a Cooperative Research and Development Agreement (CRADA)
to develop a hepatitis C virus (HCV) vaccine based on in the synthesis,
large scale production and purification of non-infectious HCV-like
particles containing HCV structural proteins (Baumert, TF et al. 1998,
J. Virol. 72:3827-3836).
The invention claimed in DHHS Reference No. E-009-97/0, ``Synthesis
and Purification of Hepatitis C Virus-Like Particles In Vitro'' (TJ
Liang, TF Baumert), field 08 Nov 96, is available for 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.
DATES: Only written CRADA capability statements received by the NIDDK
on or before March 1, 1999 will be considered. There is no deadline by
which license applications must be received.
ADDRESSES: Capability statements should be submitted to Dr. Michael W.
Edwards, Office or Technology Development, National Institute Diabetes
and Digestive and Kidney Diseases, National Institutes of Health, BSA
Building, Suite 350 MSC 2690, 9190 Rockville Pike, Bethesda, MD 20814-
3800; Tel: 301/496-7778, Fax: 301/402-0535; Electronic mail:
[email protected].
Questions about the licensing opportunity, copies of the patent
application, or requests for license applications should be addressed
to Carol Salata, Ph.D., Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Rockville, MD 20852-3804; Tel: 301/496-7057 ext. 232; Fax:
301/402-0220; Electronic mail: [email protected].
SUPPLEMENTARY INFORMATION: HCV is a major causative agent of post-
transfusion and community-acquired non-A, non-B hepatitis world-wide.
About 4 million people in the U.S. and probably more than 100 million
worldwide are infected with HCV. The majority of HCV infected
individuals become persistently infected and many develop chronic
hepatitis which progresses eventually to liver cirrhosis and
hepatocellular carcinoma.
HCV is a member of the flavivirus family. The HCV viron contains a
positive-strand RNA genome of 9.5 kilobases including a highly
conserved 5' non-coding region followed by a long open reading frame of
9030 to 9099 nucleotides that is translated into a single polyprotein
about 3,010 to 3030 amino acids long. Although the viral genomic
organization has been characterized in detail, morphologic analysis of
hepatitis C virus has been hampered by low levels of HCV particles in
infected patients and the inability to propagate efficiently the virus
in cultured cells. The levels of the viral particles present in
infected patient plasma and/or liver tissues are very low, making it
difficult to visualize the virus. Studies of HCV infection in
chimpanzees, a reliable animal model for hepatitis C, have provided
evidence that HCV is inactivated by chloroform, indicating that it
contains lipids and therefore is probably enveloped. Filtration studies
have estimated the viron particle size to be about 30-60 nm in
diameter.
Under the CRADA the synthesis, large scale production, and
purification of HCV virus-like particles 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 humans.
NIDDK's principal investigator has extensive experience with
recombinant technology as applied to the synthesis, purification and
testing of HCV-like particles. The Collaborator in this endeavor is
expected to assist NIDDK in evaluating its current system for producing
HCV vaccine formulation and to develop and optimize adjuvants, if
necessary, to manufacture sufficient quantities of the product for
preclimical testing in animals and initial safety studies in humans.
The Collaborator must have experience in the manufacture of vaccine
formulations 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 NIDDK PI'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 vaccine formulation and development,
(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, efficacy 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.
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 applications for licensing was first
published in the Federal Register on January 28, 1998 (63 FR 4274).
Information about the patent applications and pertinent information not
yet publicly described may be obtained under a Confidential Disclosure
Agreement. Respondees interested in licensing the invention(s) will be
required to submit an Application for License to Public Health Service
Inventions. Respondees interested in submitting a CRADA proposal should
be aware that it may be necessary to secure a license to the above
patent rights in order to
[[Page 67697]]
commercialize products arising from a CRADA.
Dated: December 1, 1998.
Jack Spiegel,
Director, Division of Technology, Development and Transfer, Office of
Technology Transfer.
[FR Doc. 98-32491 Filed 12-7-98; 8:45 am]
BILLING CODE 4140-01-M