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


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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.

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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: 
[email protected].
    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: [email protected].
    Information regarding NCI drug development collaborations with the 
Cancer Therapy Evaluation Program can be found at http://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), (http://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 RS=PN/5539112);
    2. European Patent No. 0638566 (issued 01/07/1999 and validated in 
GB, DE, FR, ES and IT), (http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=EP0638566&F=0);
    3. Canadian Patent Application No. 2129813 (filed 08/09/1994), 
(http://patents1.ic.gc.ca/details?patent_number=2129813&language=EN =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), (http://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 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), 
(http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US2004019227&F=0);
    3. Canada Patent Application No. 2405747 (filed April 6, 2001), 
http://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 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