[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Notices]
[Page 43002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21093]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: New Brefeldin a 
Derivatives

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i) that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive world-wide license to practice the inventions embodied in 
U.S. Patent Application Serial Number 08/267,525, entitled ``New 
Brefeldin A Derivatives And Their Utility In The Treatment Of Cancer,'' 
and corresponding U.S. and foreign patent applications to Allelix 
Biopharmaceuticals, Inc. of Mississauga, Ontario, Canada. The patent 
rights of the NIH inventors in these inventions have been assigned to 
the United States of America.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before October 10, 1997, will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Raphe Kantor, Ph.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804; Telephone: (301) 496-7056 ext. 247; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications.

SUPPLEMENTARY INFORMATION: This invention relates to a new class of 
compounds which can be characterized as breveldin A derivatives, e.g., 
4-O-(N,N-dimethylglycyl) breveldin A; 7-O-(N-N-dimethylglycyl) 
breveldin A. These breveldin A analogs are more water soluble than the 
parent compound. These analogs appear to have reduced toxicities which 
limited the clinical utility of the parent compound. These compounds 
exhibit activity against a wide variety of cancers, including colon 
cancer, melanoma, leukemia, ovarian, prostate, breast and renal tumors. 
However, recently performed toxicity studies on one breveldin A analog 
(breflate) found that it still retained an unacceptable toxicity 
profile.
    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 404.7. 
The prospective exclusive license may be granted unless within sixty 
(60) days from the date of this published notice, 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 404.7.
    Applications for a license filed in response to this notice will be 
treated as objections to the grant of the contemplated licenses. 
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.

    Dated: August 1, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-21093 Filed 8-8-97; 8:45 am]
BILLING CODE 4140-01-P