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Notice

National Cancer Institute: Development of Inhibitors of the Hypoxia Inducible Factor (HIF-1) Transcriptional Activation Pathway

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An opportunity is available for a Cooperative Research and Development Agreement (CRADA) for the purpose of collaborating with the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Developmental Therapeutics Program (DTP), Screening Technologies Branch (STB), on further research and development of small molecule inhibitors of the Hypoxia Inducible Factor 1 (HIF-1) transcriptional activation pathway.

AGENCY:

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

ACTION:

Notice of opportunities for cooperative research and development.

SUMMARY:

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 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 to develop novel small molecule inhibitors of the Hypoxia Inducible Factor 1 (HIF-1) transcriptional activation pathway. 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 Start Printed Page 47233Collaborator 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.

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: Giovanni Melillo, M.D., DTP-Tumor Hypoxia Laboratory, Bldg 432, Rm 218, National Cancer Institute, Frederick, MD 21702 (phone 301-846-5050; FAX 301-846-6081; e-mail: melillo@dtpax2.ncifcrf.gov) or Robert H. Shoemaker, Ph.D., Screening Technologies Branch, Bldg 440, National Cancer Institute, Frederick, MD 21702.

EFFECTIVE DATE:

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 on or before October 11, 2001. 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.

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SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists within the DTP-STB Tumor Hypoxia Laboratory have developed a number of human tumor cell lines engineered to express the luciferase reporter gene in an HIF-1 dependent fashion. These engineered cell lines express high levels of luciferase when cultured under hypoxic conditions and can be used as a tool for discovering small molecules that inhibit HIF-1 transcriptional activity.

Technology Sought

Accordingly, DHHS now seeks collaborative arrangements for the joint elucidation, evaluation and development of small molecules that inhibit the HIF-1 pathway. The successful Collaborator should possess experience in the following areas at a minimum: preclinical research and drug development of HIF-1 inhibitors, performance of in vitro assays targeting HIF-1 transcriptional activity, development of in vitro and in vivo models targeting hypoxia induced angiogenesis. 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-Screening Technologies Branch (STB) 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.

8. The willingness to cooperate with the National Cancer Institute in the timely publication of research results.

9. 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.

10. 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.

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Dated: August 24, 2001.

Kathleen Sybert,

Chief, Technology Transfer Branch, National Cancer Institute, National Institutes of Health.

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[FR Doc. 01-22793 Filed 9-10-01; 8:45 am]

BILLING CODE 4140-01-P