[Federal Register Volume 66, Number 229 (Wednesday, November 28, 2001)]
[Notices]
[Pages 59440-59441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: PEGylation of Cyanovirin-N for Use in 
Treating Infectious Diseases

AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice of opportunities for cooperative research and 
development.

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SUMMARY: An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
National Cancer Institute (NCI), Center for Cancer Research (CCR), 
Molecular Targets Drug Discovery Program (MTDDP), on further research 
and development of the use of poly[ethylene glycol] (PEG) conjugates of 
the antiviral protein, cyanovirin-N (CV-N) and antiviral homologs 
thereof. Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710, as amended; and Executive Order 12591 of April 10, 
1987), the National Cancer Institute (NCI) of the National Institutes

[[Page 59441]]

of Health (NIH) of the Public Health Service (PHS) of the Department of 
Health and Human Services (DHHS) seeks a Cooperative Research and 
Development Agreement (CRADA) with a pharmaceutical or biotechnology 
company for collaborative creation, research and development of 
poly[ethylene glycol] (PEG) conjugates of the antiviral protein, 
cyanovirin-N (CV-N) and antiviral homologs thereof. More specifically, 
a commercial partner is sought for collaborative R&D of PEG-CV-N 
conjugates for non-retroviral fields of use. Examples of non-
retroviruses of interest include influenza viruses A&B, measles virus, 
human herpesvirus 6 (HHV-6) and related viruses. Any CRADA for the 
biomedical use of this technology will be considered. The CRADA would 
have an expected duration of one (1) to five (5) years. The goals of 
the CRADA include the rapid publication of research results and timely 
commercialization of products, diagnostics and treatments that result 
from the research. The CRADA Collaborator will have an option to elect 
a non-exclusive or exclusive commercialization license to subject 
inventions arising under the CRADA and which are subject of the CRADA 
Research Plan.

DATES: Inquiries regarding CRADA proposals and scientific matters may 
be forwarded at any time. Confidential CRADA proposals, preferably two 
pages or less, must be submitted to the NCI within 30 days from date of 
this publication. 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.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Transfer Branch, 
National Cancer Institute-Frederick, Fairview Center, Room 502, 
Frederick, MD 21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries should be directed to: Michael Boyd, M.D./ 
Ph.D., Chief, Molecular Targets Drug Discovery Program, Bldg 1052, 
National Cancer Institute, Frederick, MD 21702 (phone 301-846-5391; FAX 
301-846-6919; e-mail: [email protected]).

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists within the MTDDP have extensive experience with the 
chemistry and biology of CV-N and related antiviral proteins. More 
specifically, MTDDP has expertise and technology for protein chemistry, 
protein mutagenesis and bioengineering and antiviral evaluations 
pertinent to this proposed collaboration. Whereas MTDDP is currently 
engaged in a CRADA collaboration on HIV fields of use of PEG-CV-N's, 
the new collaboration proposed herein will focus on non-retroviruses, 
including but not limited to influenza viruses types A&B, measles 
virus, human herpesvirus 6 (HHV-6), and related viruses.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements for the 
construction and antiviral research and development of PEG-CV-N 
conjugates against non-retroviruses. The successful Collaborator should 
possess experience in the following areas at a minimum: pegylation 
(PEG) chemistry, biology and pharmacology of PEG-protein conjugates, 
preclinical and clinical development expertise for pegylated proteins 
as therapeutic and/or preventative agents, preferably against viral 
diseases. For collaborations with the commercial sector, a Cooperative 
Research and Development Agreement (CRADA) will be established to 
provide equitable distribution of intellectual property rights 
developed under the CRADA. CRADA aims will include rapid publication of 
research results as well as development of the technology toward 
commercialization. The role of the National Cancer Institute-Molecular 
Targets Drug Discovery Program (MTDDB) in this CRADA will include, but 
not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with pertinent available reagents for 
investigation/evaluation.
    3. Planning research studies and interpreting research results.
    4. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Planning research studies and interpreting research results.
    3. Providing technical expertise and/or financial support (e.g. 
facilities, personnel and expertise) for CRADA-related research as 
outlined in the CRADA Research Plan.
    4. Accomplishing objectives according to an appropriate timetable 
to be outlined in the CRADA Collaborator's proposal.
    5. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    6. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    7. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    8. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    9. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern patent rights to CRADA inventions.

    Dated: November 7, 2001.
Kathleen Sybert,
Chief, Technology Transfer Branch, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 01-29545 Filed 11-27-01; 8:45 am]
BILLING CODE 4140-01-P