Government-Owned Inventions; Availability for Licensing and Cooperative Research and Development Agreement (CRADA): Aminoflavone Prodrug, 42349-42350 [05-14495]

Download as PDF 42349 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices ESTIMATES OF HOUR BURDEN Number of respondents Type of respondents Frequency of response Average time per response Total hour burden Public, including people at risk for diabetes, patients and their family members .............................................................................................................. 1600 1 .25 400 Totals ........................................................................................................ 1,600 ........................ ........................ 400 Frequency of response Hourly wage rate COST TO RESPONDENTS Number of respondents Type of respondents Respondent cost Public, including people at risk for diabetes, patients and their family members .............................................................................................................. 1600 1 $20.00 $8,000.00 Total .......................................................................................................... ........................ ........................ ........................ $8,000.00 Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Joanne Gallivan, M.S., R.D., Director, National Diabetes Education Program, NIDDK, NIH, Building 31, Room 9A04, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 494– 6110 or e-mail your request, including your address to: Joanne_Gallivan@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect VerDate jul<14>2003 19:28 Jul 21, 2005 Jkt 205001 received within 30 days of the date of this publication. Dated: June 28, 2005. Barbara Merchant, Executive Officer, NIDDK, National Institutes of Health. [FR Doc. 05–14491 Filed 7–21–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing and Cooperative Research and Development Agreement (CRADA): Aminoflavone Prodrug National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions described below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 in association with collaborative research via a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) of the National Institutes of Health. This opportunity is being offered to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information may be obtained by contacting George G. Pipia, PhD., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; telephone: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 301/435–5560; fax: 301/402–0220; email: PipiaG@mail.nih.gov. CRADA inquiries may be addressed to Robert Wagner, M.S., M. Phil., at the Technology Transfer Branch, National Cancer Institute, 6120 Executive Boulevard, Suite 450, Rockville, MD 20852; telephone: 301/496–0477; fax: 301–402–2117; e-mail: WagnerB@mail.nih.gov. Information regarding NCI drug development collaborations with the Cancer Therapy Evaluation Program can be found at https://ctep.cancer.gov/. SUPPLEMENTARY INFORMATION: Scientists at the National Cancer Institute (NCI), NIH, have developed a novel anti-cancer agent, the aminoflavone prodrug (AFP– 464, NSC 710464) which is a lysyl prodrug of aminoflavone (AF, NSC 686288). AFP–464 displays improved solubility in aqueous solutions over the parent compound AF and can be converted rapidly to AF in plasma. In the NCI 60-cell-line screen, both AFP– 464 and AF have demonstrated antiproliferative activity against several renal, breast and ovarian cancer cell lines. AFP–464 and AF have also demonstrated anti-tumor activity in human renal and breast carcinoma xenografts. Pharmacokinetic studies and toxicology studies of AFP–464 have been completed. The results of the pre-clinical studies conducted by NCI have led to a decision by the NCI to initiate NCI-sponsored clinical trials of AFP–464. The Cancer Therapy Evaluation Program (CTEP), NCI expects to file an Investigational New Drug Application with the FDA for AFP–464 before the end of 2005. Patent Portfolio: The patent portfolio for the aminoflavone compounds and the aminoflavone prodrug, claiming the compositions of matter and methods in the treatment of cancer includes issued patents and patent applications E:\FR\FM\22JYN1.SGM 22JYN1 42350 Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices claiming rights worldwide, as provided below (websites for patent application publications are included). Patents and patent applications for the aminoflavone compounds, entitled ‘‘5–Aminoflavone Derivative,’’ consist of: 1. U.S. Patent No. 5,539,112 (issued 07/23/1996), (https://patft.uspto.gov/ netacgi/nph-Parser? Sect1=PTO1&Sect2= HITOFF&d=PALL&p=1&u=/netahtml/ srchnum.htm&r=1& f=G&l=50&s1=5539112.WKU.&OS=PN/ 5539112&RS=PN/5539112); 2. European Patent No. 0638566 (issued 01/07/1999 and validated in GB, DE, FR, ES and IT), (https:// v3.espacenet.com/textdoc?DB= EPODOC&IDX=EP0638566&F=0); 3. Canadian Patent Application No. 2129813 (filed 08/09/1994), (https:// patents1.ic.gc.ca/details?patent_ number=2129813&language=EN). Patents and patent applications for the aminoflavone prodrug, entitled ‘‘Aminoflavone Compounds, Compositions, and Methods of Use Thereof,’’ consist of: 1. U.S. Patent No. 6,812,246 (issued 11/02/2004), (https://patft.uspto.gov/ netacgi/nph-Parser?Sect1= PTO1&Sect2=HITOFF&d= PALL&p=1&u=/netahtml/ srchnum.htm&r=1&f= G&l=50&s1=6812246.WKU.&OS=PN/ 6812246&RS=PN/6812246); 2. European Patent Application No. 01923228.9 (filed April 6, 2001, now allowed and validated in GB, DE, FR, IT, ES, LU, BE, CH, and IE), (https:// v3.espacenet.com/ textdoc?DB=EPODOC&IDX= US2004019227&F=0); 3. Canada Patent Application No. 2405747 (filed April 6, 2001), https:// patents1.ic.gc.ca/ details?patent_number= 2405747&language=EN); 4. Australia Patent Application No. 2001249940 (filed April 6, 2001), (http:/ /apa.hpa.com.au:8080/ipapa/ view?hit=1&page=1). Licensing and Cooperative Research and Development Agreement Opportunity: The National Cancer Institute (NCI) seeks a collaborator to codevelop the aminoflavone pro-drug (AFP–464) for clinical use. A Cooperative Research and Development Agreement (CRADA) is the anticipated collaborative agreement to be entered into with NCI pursuant to the Federal Technology Transfer Act of 1986 and Executive Order 12591 of April 10, 1987, as amended. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government VerDate jul<14>2003 19:28 Jul 21, 2005 Jkt 205001 laboratories. A CRADA is not a grant, and it is not a contract for the procurement of goods/services. The NCI is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, NCI can contribute facilities, staff, materials, and expertise. The CRADA collaborator can contribute facilities, staff, materials, expertise, and funds. The CRADA collaborator will also have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, diagnostics, and treatments that result from the research. Licensing the above patent rights will be necessary to commercialize AFP–464 if clinical trials results are favorable. It is expected that a licensee to the above patent rights will become the NCI CRADA collaborator in the clinical development of AFP–464. Those interested in this CRADA opportunity should prepare a confidential proposal and submit it to the NCI Technology Transfer Branch. Preference will be given to proposals received by the NCI within thirty days of publication of this announcement. Selection criteria for choosing the CRADA Collaborator shall include, but not be limited to: 1. Demonstrated expertise and success in clinical development of anti-cancer agents; 2. possession of the resources needed to support and perform the research and development activities to develop AFP– 464 (e.g. facilities, personnel and expertise); 3. the ability to provide financial support for the CRADA-related Government activities; 4. the demonstration of the necessary resources to produce and supply formulated AFP–464 for all clinical trials in a timely manner; 5. the willingness to cooperate with the NCI in the timely publication of research results; 6. the willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any; and 7. the agreement to be bound by the appropriate HHS regulations relating to human subjects. Dated: July 15, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–14495 Filed 7–21–05; 8:45 am] BILLING CODE 4140–01–U PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: (301) 496–7057; fax: (301) 402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Standardizing Criteria on Cancer Biomarkers as Foundation of a Database: Creating a Common Language (Data Elements) for Cancer Biomarkers Tracking and Utilization for Professionals in Oncology Research Mahin Khatami (NCI) HHS Reference No. E–147–2005/0— Research Tool Licensing Contact: Michelle A. Booden; (301) 451–7337; boodenm@mail.nih.gov. Cancer biomarkers (CBs) are important biological tools in modern oncology research for diagnosis, prognosis, prevention, therapy and outcome. Biological characters of biomarkers are as diversified as their utilization potentials. Biomarkers may be proteins/peptides, glycoproteins, lipids, glycolipids, antigens/antibodies, cytokines/chemokines, receptors, enzymes, inhibitors, nutrients/ metabolites, DNA/RNA mutations, etc. CBs are found in blood/serum, urine, other biological fluids, and/or tissue specimen. The NCI has identified a common set of data elements or criteria to describe a large number of cancer biomarkers. These data elements may be used as a foundation for a cancer biomarker E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Pages 42349-42350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14495]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing and 
Cooperative Research and Development Agreement (CRADA): Aminoflavone 
Prodrug

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

ACTION: Notice.

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

SUMMARY: The inventions described below are owned by an agency of the 
U.S. Government and are available for licensing in the U.S. in 
accordance with 35 U.S.C. 207 in association with collaborative 
research via a Cooperative Research and Development Agreement (CRADA) 
with the National Cancer Institute (NCI) of the National Institutes of 
Health. This opportunity is being offered to achieve expeditious 
commercialization of results of federally funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

ADDRESSES: Licensing information may be obtained by contacting George 
G. Pipia, PhD., at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; telephone: 301/435-5560; fax: 301/402-0220; e-mail: 
PipiaG@mail.nih.gov.
    CRADA inquiries may be addressed to Robert Wagner, M.S., M. Phil., 
at the Technology Transfer Branch, National Cancer Institute, 6120 
Executive Boulevard, Suite 450, Rockville, MD 20852; telephone: 301/
496-0477; fax: 301-402-2117; e-mail: WagnerB@mail.nih.gov.
    Information regarding NCI drug development collaborations with the 
Cancer Therapy Evaluation Program can be found at https://
ctep.cancer.gov/.

SUPPLEMENTARY INFORMATION: Scientists at the National Cancer Institute 
(NCI), NIH, have developed a novel anti-cancer agent, the aminoflavone 
prodrug (AFP-464, NSC 710464) which is a lysyl prodrug of aminoflavone 
(AF, NSC 686288). AFP-464 displays improved solubility in aqueous 
solutions over the parent compound AF and can be converted rapidly to 
AF in plasma. In the NCI 60-cell-line screen, both AFP-464 and AF have 
demonstrated anti-proliferative activity against several renal, breast 
and ovarian cancer cell lines. AFP-464 and AF have also demonstrated 
anti-tumor activity in human renal and breast carcinoma xenografts. 
Pharmacokinetic studies and toxicology studies of AFP-464 have been 
completed.
    The results of the pre-clinical studies conducted by NCI have led 
to a decision by the NCI to initiate NCI-sponsored clinical trials of 
AFP-464. The Cancer Therapy Evaluation Program (CTEP), NCI expects to 
file an Investigational New Drug Application with the FDA for AFP-464 
before the end of 2005.
    Patent Portfolio: The patent portfolio for the aminoflavone 
compounds and the aminoflavone prodrug, claiming the compositions of 
matter and methods in the treatment of cancer includes issued patents 
and patent applications

[[Page 42350]]

claiming rights worldwide, as provided below (websites for patent 
application publications are included).
    Patents and patent applications for the aminoflavone compounds, 
entitled ``5-Aminoflavone Derivative,'' consist of:
    1. U.S. Patent No. 5,539,112 (issued 07/23/1996), (https://
patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=
1&u=/netahtml/ srchnum.htm&r=1& f=G&l=50&s1=5539112.WKU .&OS=PN/
5539112& RS=PN/5539112);
    2. European Patent No. 0638566 (issued 01/07/1999 and validated in 
GB, DE, FR, ES and IT), (https://v3.espacenet.com/textdoc?DB=
EPODOC&IDX=EP0638566&F=0);
    3. Canadian Patent Application No. 2129813 (filed 08/09/1994), 
(https://patents1.ic.gc.ca /details?patent-- number=2129813&language 
=EN).
    Patents and patent applications for the aminoflavone prodrug, 
entitled ``Aminoflavone Compounds, Compositions, and Methods of Use 
Thereof,'' consist of:
    1. U.S. Patent No. 6,812,246 (issued 11/02/2004), (https://patft.
uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/
netahtml/ srchnum.htm&r=1&f= G&l=50&s1=6812246.WKU.& OS=PN/6812246&RS= 
PN/6812246);
    2. European Patent Application No. 01923228.9 (filed April 6, 2001, 
now allowed and validated in GB, DE, FR, IT, ES, LU, BE, CH, and IE), 
(https://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US2004019227&F=0);
    3. Canada Patent Application No. 2405747 (filed April 6, 2001), 
https://patents1.ic.gc.ca/ details?patent--number= 2405747&language=EN);
    4. Australia Patent Application No. 2001249940 (filed April 6, 
2001), (https://apa.hpa.com.au:8080/ ipapa/view?hit=1&page=1).
    Licensing and Cooperative Research and Development Agreement 
Opportunity: The National Cancer Institute (NCI) seeks a collaborator 
to co-develop the aminoflavone pro-drug (AFP-464) for clinical use. A 
Cooperative Research and Development Agreement (CRADA) is the 
anticipated collaborative agreement to be entered into with NCI 
pursuant to the Federal Technology Transfer Act of 1986 and Executive 
Order 12591 of April 10, 1987, as amended. A CRADA is an agreement 
designed to enable certain collaborations between Government 
laboratories and non-Government laboratories. A CRADA is not a grant, 
and it is not a contract for the procurement of goods/services. The NCI 
is prohibited from transferring funds to a CRADA collaborator. Under a 
CRADA, NCI can contribute facilities, staff, materials, and expertise. 
The CRADA collaborator can contribute facilities, staff, materials, 
expertise, and funds. The CRADA collaborator will also have an option 
to negotiate the terms of an exclusive or non-exclusive 
commercialization license to subject inventions arising under the 
CRADA. The goals of the CRADA include the rapid publication of research 
results and timely commercialization of products, diagnostics, and 
treatments that result from the research. Licensing the above patent 
rights will be necessary to commercialize AFP-464 if clinical trials 
results are favorable. It is expected that a licensee to the above 
patent rights will become the NCI CRADA collaborator in the clinical 
development of AFP-464.
    Those interested in this CRADA opportunity should prepare a 
confidential proposal and submit it to the NCI Technology Transfer 
Branch. Preference will be given to proposals received by the NCI 
within thirty days of publication of this announcement. Selection 
criteria for choosing the CRADA Collaborator shall include, but not be 
limited to: 1. Demonstrated expertise and success in clinical 
development of anti-cancer agents; 2. possession of the resources 
needed to support and perform the research and development activities 
to develop AFP-464 (e.g. facilities, personnel and expertise); 3. the 
ability to provide financial support for the CRADA-related Government 
activities; 4. the demonstration of the necessary resources to produce 
and supply formulated AFP-464 for all clinical trials in a timely 
manner; 5. the willingness to cooperate with the NCI in the timely 
publication of research results; 6. the willingness to accept the legal 
provisions and language of the CRADA with only minor modifications, if 
any; and 7. the agreement to be bound by the appropriate HHS 
regulations relating to human subjects.

    Dated: July 15, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-14495 Filed 7-21-05; 8:45 am]
BILLING CODE 4140-01-U
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