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Notice

Prospective Grant of Exclusive License: Method of Treating Cancer in Humans Using IL-21

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Information about this document as published in the Federal Register.

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patent Application 60/368,438 (re-filed), PCT Patent Application No. PCT/US03/09707, filed March 27, 2003 (DHHS ref. E-137-2002/0-PCT-02), entitled “Method of Treating Cancer in Humans,” to Actis Biologics, Inc., which is located in Livermore, California. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide and the field of use may be limited to human therapeutics for the treatment of cancer via use of IL-21 with the company's proprietary Viral Vector delivery system.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before March 16, 2004, will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: George G. Pipia, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; telephone: (301) 435-5560; facsimile: (301) 402-0220; e-mail: pipiag@mail.nih.gov.

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SUPPLEMENTARY INFORMATION:

The primary technology describes the use of IL-21 for cancer therapy and/or cancer prevention. When compared to similar cytokines, IL-21 has shown substantial anticancer activity and reduced toxicity in murine models.

IL-21 belongs to the class I family of cytokines and is closely related to IL-2 and IL-15. Some cancer patients have shown significant response to administration of IL-2. However, IL-2 has also been associated with severe toxicity leading to a variety of undesirable side effects. This invention attempts to resolve the toxicity concerns and presents a new therapy for cancer prevention and treatment.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

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Dated: January 12, 2004.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 04-1021 Filed 1-15-04; 8:45 am]

BILLING CODE 4140-01-P