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Opportunity for Licensing: Adenovirus Mediated Transfer of Genes

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

The National Institutes of Health (NIH), Public Health Service (PHS), Department of Health and Human Services (DHHS), seeks a licensee(s) to develop gene therapy-based therapeutics that would be effective in the treatment of a variety of disease states, particularly via transfer of specific genes to the lung. The inventors have developed adenoviral Start Printed Page 17515vectors and pharmaceutical compositions comprising (a) a replication defective adenovirus comprising a deletion in the E1A, E1B and E3 regions and further comprising a DNA segment encoding a specific protein of interest operatively linked to a promoter and (b) a pharmaceutically acceptable carrier for said vector. Examples of proteins of interest would include, but not be necessarily limited to, CFTR and α1-antitrypsin.

The NIH seeks licensee(s) who, in accordance with requirements and regulations governing the licensing of government-owned inventions (37 CFR 404), has the most meritorious plan for the development of a therapeutic agent(s) to meet the needs of the public and with the best terms for the government. NIH intends to grant the selected licensee(s) a world-wide royalty-bearing license(s) to practice the inventions embodied in U.S. Patent 6,013,638 entitled “Adenovirus Comprising Deletions on the E1A, E1B and E3 Regions for Transfer of Genes to the Lung” U.S. Patent Application S/N 09/364,839 entitled “Adenovirus-Mediated Transfer of Genes to the Lung”; U.S. Patent Application S/N 09/307,141 entitled “Adenovirus-Mediated Transfer of Genes to the Lung” and U.S. Patent Application S/N 08/442,262 entitled “Replication Deficient Recombinant Adenovirus Vector”. The United States of America is an assignee for the patent rights in these inventions.

ADDRESSES:

Licensing information, a copy of the U.S. patent or applications referenced to above or a copy of the NIH License Application may be obtained by contacting Richard U. Rodriguez, M.B.A., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804 (telephone 301/496-7056 ext 287; fax 301/402-0220; and E-mail rr154z@nih.gov). A signed Confidential Disclosure Agreement is required to receive a copy of any patent application.

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SUPPLEMENTARY INFORMATION:

One of the hurdles to overcome in most forms of somatic gene therapy is the specific delivery of a therapeutic gene, encoding a therapeutic protein, to the organ manifesting the disease. In the case of the lung, a functional gene can be delivered directly to the respiratory epithelium by means of tracheal installation. One serious disadvantage with this approach is encountered with the use of vectors (such as retroviruses) that require proliferation of the target cells for expression of the newly transferred gene because only a small proportion of alveolar and airway epithelial cells go through the proliferative cycle in one day and because a large proportion of these cells are terminally differentiated. Use of the claimed recombinant adenoviral vector to transfer a gene to the respiratory epithelium in vivo circumvents the problem of slow target-cell proliferation. Other advantages would include: rare recombination events; no known associations of human malignancies with adenoviral infections despite common human infection with adenoviruses; the adenovirus genome can be manipulated to accommodate foreign genes expressing proteins ranging in size from small peptides up to a peptide of 7.0 to 7.5 kB in length; and live adenovirus has been safely used as a human vaccine.

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Dated: March 24, 2000.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.

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[FR Doc. 00-8107 Filed 3-31-00; 8:45 am]

BILLING CODE 4140-01-P