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Notice

National Heart, Lung, and Blood Institute (NHLBI); Opportunity for a Cooperative Research and Development Agreement (CRADA) to Identify and Explore Epigenetic Regulatory Elements for Diagnostic and Therapeutics Purposes

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The National Heart, Lung, and Blood Institute (NHLBI) is seeking Cooperative Research and Development Agreement (CRADA) collaborator(s) to work with investigators in the Laboratory of Molecular Immunology (LMI) to identify epigenetic regulatory elements that may be involved in the disease development of T and/or B cell leukemia/lymphoma and other cancers via genome-wide analysis of acetylation islands using the Genome-Wide Mapping Technique (GMAT). Representative disease-specific acetylation islands will be explored for diagnostic and therapeutic purposes.

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SUPPLEMENTARY INFORMATION:

Epigenetics play a critical role in cellular development and cellular transformation in many pathogenic processes. For example, many cancers are correlated with changes of their chromatin structure and are sensitive to drugs that modulate the levels of histone acetylation. Epigenetic regulation refers to the modification of chromatin including posttranslational modification of histones, which does not involve change of DNA sequences of target genes. MHLBI investigators have mapped the genome-wide distribution of histone H3 acetylation in human T cells and discovered over 40,000 acetylation islands using a technique called GMAT. This tool combines Chromatin immunoprecipitation (Chip) of hyper-acetylated histones, with Serial Analysis of Gene Expression (SAGE). The acetylation islands are epigenetic markers for transcriptional regulatory elements and chromatin controlling elements. Changes of the acetylation islands may be correlated with early development of T cell lymphoma or leukemia. Therefore, this discovery may be applied to early diagnosis and/or treatment of these diseases.

The NHLBI is seeking capability statements from parties interested in entering into a CRADA to identify, explore and further develop epigenetic regulatory elements/acetylation islands for diagnostic and therapeutic purposes. The role of the CRADA collaborator(s) will include, but not be limited to, the following:

1. The ability to collaborate with NHLBI on further research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to on-going research and development.

2. To assist with obtaining specimen/tissues (patient and normal controls) for the Genome-Wide analysis as diagnostic and therapeutic markers.

3. To assist to further developing the epigenetic regulatory elements markers/acetylation islands as new targets for novel drug-development strategies.

The collaborator may also be expected to contribute financial support under this CRADA for personnel, supplies, travel, and equipment to support these projects. The collaborator is also expected to cooperate with the NHLBI in the timely publication of research results and to accept the legal provisions and language of the CRADA with only minor modifcations, if any.

DATES:

CRADA capability statements should be submitted to Vincent Kolesnitchenko, Ph.D., Technology Transfer Specialist, National Heart, Lung, and Blood Institute (NHLBI), Office of Technology Transfer and Development, National Institutes of Health, 6705 Rockledge Drive, Suite 6018, MSC 7992, Bethesda, MD 20892-7992; Phone: (301) 594-4115; Fax: (301) 594-3080; E-mail: vk5q@nih.gov. Capability statements must be received on or before March 28, 2005.

The NHLBI has applied for patents claiming the core of the technology. Non-exclusive and/or exclusive licenses for these patents covering core aspects of this project are available to interested parties.

Licensing inquiries regarding this technology should be addressed to John Stansberry, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, Phone: (301) 435-5236; Fax: (301) 402-0220; E-mail: stansbej@od.nih.gov. Information about Patent Applications and pertinent information not yet publicly described an be obtained under the terms of a Confidential Disclosure Agreement.

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.

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Dated: January 14, 2005.

Dr. Carl Roth,

Associate Director for Scientific Program Operations, National Heart, Lung, and Blood Institute.

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[FR Doc. 05-1412 Filed 1-25-05; 8:45 am]

BILLING CODE 4140-01-M