[Federal Register Volume 61, Number 104 (Wednesday, May 29, 1996)]
[Notices]
[Pages 26915-26916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13375]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


National Cancer Institute: Opportunity for a Cooperative Research 
and Development Agreement (CRADA) for the Scientific and Commercial 
Development of Hydroxylated Aromatic Protein Cross-Linking Compounds 
for the Treatment of Hyperproliferative Epithelial Lesions

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services (DHHS) seeks a 
company that can collaboratively pursue the pre-clinical and clinical 
development of Hydroxylated Aromatic Protein Cross-Linking Compounds 
for the treatment of hyperproliferative epithelial lesions including 
skin neoplasia, warts and other hyperproliferative skin disorders. The 
National Cancer Institute, Laboratory of Cellular Carcinogenesis and 
Tumor Promotion (LCCTP) has established that this class of compounds 
(cinnamic acid derivatives) may be effective in treating 
hyperproliferative skin disorders. The selected sponsor will be awarded 
a CRADA for the co-development of this agent with the National Cancer 
Institute.

ADDRESS: Questions about this opportunity may be addressed to Jeremy A. 
Cubert, M.S., J.D., Office of Technology Development, NCI, 6120 
Executive Blvd., MSC 7182, Bethesda MD 20892-7182, Phone: (301) 496-
0477, Facsimile: (301) 402-2117, from whom further information may be 
obtained.

DATE: In view of the important priority of developing new agents for 
the treatment or prevention of cancer, interested parties should notify 
this office in writing no later than July 12, 1996. Respondents will 
then be provided an additional 30 days for the filing of formal 
proposals.

SUPPLEMENTARY INFORMATION: ``Cooperative Research Development 
Agreement'' or ``CRADA'' means the anticipated joint agreement to be 
entered into by NCI pursaunt to the Federal Technology Transfer Act of 
1986 and amendments (including 104 P.L. 113) and Executive Order 12591 
of October 10, 1987 to collaborate on the specific research project 
described below.
    The Government is seeking a pharmaceutical company which, in 
accordance with the requirements of the regulations governing the 
transfer of agents in which the Government has taken an active role in 
developing (37 CFR 404.8), can further develop the subject compounds 
through Federal Food and Drug Administration approval and to a 
commercially available status to meet the needs of the public and with 
the best terms for the Government. The government has applied for a 
patent application directed to methods for the treatment for 
Hyperproliferative Epithelial Lesions by Topical Application of 
Hydroxylated Aromatic Protein Cross-Linking-Compounds.
    Methyl 2,5-dihydroxycinnamate (MC), a cinnamic acid derivative, has 
been shown to both inhibit cell growth and chemically cross-link 
proteins. The growth inhibitory and protein cross-linking activity of 
MC are independent and complementary. The cross-linking effect of the 
compounds is rapid and leads to programmed cell death for many cell 
types. At lower concentrations, the compounds inhibit tyrosine kinases 
and cell growth. The compounds have been shown to be effective in many 
cell types indicating potential for topical treatment of a wide range 
of localized hyperproliferative epithelial disorders.
    The LCCTP, Division of Basic Sciences, NCI is interested is 
establishing a CRADA with a company to assist in the continuing 
development of these compounds. The Government will provide all 
available expertise and information to date and will jointly pursue 
pre-clinical and clinical studies as required, giving the company full 
access to existing data and data developed pursuant to the CRADA. The 
successful company will provide the necessary scientific, financial and 
organizational support to establish clinical efficacy and possible 
commercial status of the subject compounds.
    The expected duration of the CRADA will be two (2) to five (5) 
years.
    The role of the National Cancer Institute, includes the following:

    1. Selection of appropriate compounds for in vitro screening.
    2. Selection of appropriate compounds for in vivo screening.
    3. Conduct in vitro screening of appropriate compounds.
    4. Identify chemical basis of activity for class of compounds.
    5. Conduct in vivo testing of appropriate compounds.
    6. Evaluation of test results.
    7. Preparation of manuscripts for publication.
    8. Relevant Government intellectual property rights are 
available for licensing through the Office of Technology Transfer, 
National Institutes of Health. For further information contact Allan 
Kiang, J.D., NIH Office of Technology Transfer, 6011 Executive 
Blvd., Suite 325, Rockville, MD 20852, Phone: (301) 496-7735 (ext. 
270); Facsimile: (301) 402-0220.

    The role of the collaborator company, includes the following:

    1. Conduct in vitro screening of appropriate compounds.
    2. Identify chemical basis of activity for class of compounds.
    3. Conduct in vivo testing of appropriate compounds.
    4. Evaluation of test results.
    5. Develop vehicle for delivery of compounds to patients.
    6. Conduct pre-clinical and clinical trials of appropriate 
candidate compounds.

    Criteria for choosing the company include its demonstrated 
experience and commitment to the following:

    1. Scientific expertise in and demonstraterd commitment to the 
treatment of skin related disorders.
    2. Scientific expertise in and demonstrated commitment to the 
development of drug delivery systems.
    3. Experience in preclinical and clinical drug development.
    4. Experience and ability to produce, package, market and 
distribute pharmaceutical products.
    5. Experience in the monitoring, evaluation and interpretation 
of the data from

[[Page 26916]]

investigational agent clinical studies under an IND.
    6. A willingness to cooperate with the NCI in the collection, 
evaluation, publication and maintaining of data from pre-clinical 
studies and clinical trials regarding the subject compounds.
    7. Provide defined financial and personnel support for the CRADA 
to be mutually agreed upon.
    8. An agreement to be bound by the DHHS rules involving human 
and animal subjects.
    9. The aggressiveness of the development plan, including the 
appropriateness of milestones and deadlines for preclinical and 
clinical development.
    10. Provisions for equitable distribution of patent rights to 
any CRADA inventions. Generally the rights of ownership are retained 
by the organization which is the employer of the inventor, with (1) 
an irrevocable, nonexclusive, royalty-free license to the Government 
and (2) an option for the collaborator to elect an exclusive or 
nonexclusive license to Government owned rights under terms that 
comply with the appropriate licensing statutes and regulations.

    Dated: May 1, 1996.
Thomas D. Mays,
Director, Office of Technology Development, OD, NCI.
[FR Doc. 96-13375 Filed 5-28-96; 8:45 am]
BILLING CODE 4140-01-M