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

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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 http://ctep.cancer.gov/​.

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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 Start Printed Page 42350claiming 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);

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).

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);

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.

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Dated: July 15, 2005.

Steven M. Ferguson,

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

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[FR Doc. 05-14495 Filed 7-21-05; 8:45 am]

BILLING CODE 4140-01-U