[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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