E6-6986. Prospective Grant of Exclusive License: The Development of C-6 and C-8 Modified cAMP-Derivatives for the Treatment of Cancer

AGENCY:

National Institutes of Health, Public Health Service, HHS.

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 (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 07/198,489 filed May 23, 1988, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-01], PCT Application filed May 19, 1989 [HHS Reference No. E-132-1988/0-PCT-02], U.S. Patent Application No. 07/896,452 filed June 4, 1992, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-04], U.S. Patent 5,792,752 filed October 27, 1994 and issued August 11, 1998, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-05], U.S. Patent 5,902,794 filed September 22, 1997 and issued May 11, 1999, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-US-06] and Canadian Patent Application No. 133572 filed May 19, 1989, entitled “Use of 8-Cl-cAMP as Anticancer Drug” [HHS Reference No. E-132-1988/0-CA-03], to Kuhnil Pharm. Co. Ltd., which has offices in Seoul, Republic of Korea. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of cancer with 8-Cl-cAMP.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 10, 2006 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: David A. Lambertson, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Cyclic AMP (cAMP) is a natural biological product with a number of regulatory functions at physiological levels. At higher than physiological concentrations, cAMP has the ability to inhibit the aberrant growth of malignant cells. Because cAMP is a natural product involved in normal biological function, this inhibition occurs without causing significant toxicity. However, this is not a feasible method for treating cancer in vivo because of potential interference with the physiological role of cAMP.

C-6 and C-8 modified cAMP derivatives also inhibit the growth of malignant cells. One such derivative, 8-Cl-cAMP, has effectively decreased tumor growth in vitro and in vivo. Specifically, 8-Cl-cAMP showed the ability to decrease tumor growth in leukemia mouse models and xenografts of human tumors. Because of the low toxicity associated with 8-Cl-cAMP, this compound has promise as an anti-cancer agent, particularly with regard to hematological malignancies.

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 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.

Dated: May 2, 2006.

David R. Sadowski,

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