Prospective Grant of Exclusive License: The Development of C-6 and C-8 Modified cAMP-Derivatives for the Treatment of Cancer, 28367-28368 [E6-7435]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Notices Date: June 22–23, 2006. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, 2430 Pennsylvania Ave., NW., Washington, DC 20037. Contact Person: Willaim C. Benzing, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 20892. (301) 435– 1254. benzingw@csr.nih.gov. Name of Committee: Renal and Urological Studies Integrated Review Group, Urologic and Kidney Development and Genitourinary Diseases Study Section. Date: June 26–27, 2006. Time: 8 a.m. to 11 a.m. Agenda: To review and evaluate grant applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Aftab A. Ansari, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892. 301–594– 6376. ansaria@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Digestive Sciences. Date: June 26, 2006. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Mushtaq A. Khan, DVM, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2176, MSC 7818, Bethesda, MD 20892. 301–435–1778. khanm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, SBMI— Small Business Medical Imaging. Date: June 26–27, 2006. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavillion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Xiang-Ning Li, PhD., MD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892. 301–435– 1744. lixang@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Archiving for Surveys of the Elderly—SBIR/STTR. Date: June 26, 2006. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Alfonso R. Latoni, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3022C, MSC 7770, Bethesda, MD 20892. 301–435– 1735. latonia@csr.nih.gov. VerDate Aug<31>2005 16:06 May 15, 2006 Jkt 208001 Name of Committee: Center for Scientific Review Special Emphasis Panel, Meg and Pulsed Devices. Date: June 26, 2006. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Lee Rosen, PhD., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5116, MSC 7854, Bethesda, MD 20892. (301) 435–1171. rosenl@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396. 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS.) Dated: May 10, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–4566 Filed 5–15–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: The Development of C-6 and C-8 Modified cAMP-Derivatives for the Treatment of Cancer National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 (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-ClcAMP 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 8Cl-cAMP as Anticancer Drug’’ [HHS Reference No. E–132–1988/0–US–06] PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 28367 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. This notice replaces the Prospective Grant notice published in the Federal Register on Tuesday, May 9, 2006 (71 FR 26979). DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 17, 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, PhD., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 4632; Facsimile: (301) 402–0220; E-mail: lambertsond@od.nih.gov. 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, 8Cl-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 anticancer 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 404.7. The prospective exclusive license may be granted unless E:\FR\FM\16MYN1.SGM 16MYN1 28368 Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Notices 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 10, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–7435 Filed 5–15–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Genistein and Soy Formula Expert Panel Reports; Request for Public Comment National Institute for Environmental Health Sciences (NIEHS); National Institutes of Health (NIH), HHS. ACTION: Request for comments. sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: CERHR announces the availability of the genistein and soy formula expert panel reports on the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). These expert panel reports are evaluations of the reproductive and developmental toxicity of genistein and soy formula conducted by a 14-member expert panel composed of scientists from the federal government, universities, and private organizations. CERHR invites the submission of public comments on these expert panel reports. DATES: The final genistein and soy formula expert panel reports are presently available and written public comments on these reports should be received by July 5, 2006. ADDRESSES: Public comments and any other correspondence should be sent to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC–32, Research Triangle Park, NC 27709 VerDate Aug<31>2005 16:06 May 15, 2006 Jkt 208001 (mail), (919) 316–4511 (fax), or shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. SUPPLEMENTARY INFORMATION: Background Genistein is a phytoestrogen found in some legumes, especially soybeans. Phytoestrogens are non-steriodal, estrogenic compounds that occur naturally in some plants. In plants, nearly all genistein is linked to a sugar molecule and this genistein-sugar complex is called genistin. Genistein and genistin are found in many food products, especially soy-based foods such as tofu, soy milk, and soy infant formula, and in some over-the-counter dietary supplements. Soy formula is fed to infants as a supplement or replacement for human milk or cow milk. CERHR selected genistein and soy formula for expert panel evaluation because of (1) the availability of reproductive and developmental toxicity studies in laboratory animals and humans, (2) the availability of information on exposures in infants and women of reproductive age, and (3) public concern for effects on infant or child development. The CERHR convened an expert panel on March 15–17, 2006, to review and revise the draft expert panel reports and reach conclusions regarding whether exposure to genistein or soy formula is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. Prior to the meeting, CERHR solicited public comment on the draft expert panel reports (Federal Register Vol. 70, No. 241 pp. 74834–74835). Following receipt of public comments on the genistein and soy formula expert panel reports, CERHR staff will prepare NTP–CERHR monographs on each of these substances. NTP–CERHR monographs are divided into four major sections: (1) The NTP Brief which provides the NTP’s interpretation of the potential for the chemical to cause adverse reproductive and/or developmental effects in exposed humans, (2) a roster of expert panel members, (3) the final expert panel report, and (4) any public comments received on that report. The NTP Brief is based on the expert panel report, public comments on that report, and any new information that became available after the expert panel meeting. panel report. Written comments should be sent to Dr. Michael Shelby at the address provided above. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, email, and sponsoring organization, if any). All comments received will be posted on the CERHR Web site and will be included in the NTP–CERHR monograph on the chemical. The NTP will consider all public comments during preparation of the NTP Brief. Background Information on CERHR The NTP established CERHR in June 1998 [Federal Register, December 14, 1998 (Vol. 63, No. 239, pp. 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. Expert panels conduct scientific evaluations of agents selected by CERHR in public forums. CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its Web site (https:// cerhr.niehs.nih.gov) or by contacting Dr. Shelby (see ADDRESSES above). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. The formal evaluation process was published in the Federal Register notice July 16, 2001 (Vol. 66, No. 136, pp. 37047–37048) and is available on the CERHR Web site under ‘‘About CERHR’’ or in printed copy from CERHR. Dated: May 8, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and the National Toxicology Program. [FR Doc. E6–7434 Filed 5–15–06; 8:45 am] BILLING CODE 4140–01–P Request for Comments CERHR invites written public comments on the genistein expert panel report and on the soy formula expert PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Pages 28367-28368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7435]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 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 (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.
    This notice replaces the Prospective Grant notice published in the 
Federal Register on Tuesday, May 9, 2006 (71 FR 26979).

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
17, 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, PhD., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: lambertsond@od.nih.gov.

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 404.7. 
The prospective exclusive license may be granted unless

[[Page 28368]]

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 10, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-7435 Filed 5-15-06; 8:45 am]
BILLING CODE 4140-01-P
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