[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Notices]
[Pages 4629-4630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1665]



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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 Novel Heparin-Binding Peptides

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; Executive Order 12591 of April 10, 1987), The National 
Cancer Institute (NCI) of the National Institutes of Health (NIH) of 
the Public Health Service (PHS) of the Department of Health and Human 
Services (DHHS) seeks a major pharmaceutical company which can 
effectively pursue the development of novel heparin-binding peptides 
for which a United States Patent has issued (5,357,041) and additional 
United States and foreign patent applications have been filed. NCI will 
enter into CRADA negotiations with the selected sponsor. It is the 
intention of NCI that the selected sponsor will be awarded a CRADA for 
the co-development of these peptides as inhibitors of angiogenesis and 
tumor growth. The CRADA would have an expected duration of three to 
five years.

ADDRESSES: Questions about this opportunity may be addressed to David 
R. Preston, Ph.D., Office of Technology Development, National Cancer 
Institute, Building 31, Room 4A51, National Institutes of Health, 
Bethesda, MD 20892. Phone (301) 496-0477, facsimile number (301) 402-
2117. Further information may be obtained through a confidentiality 
agreement between the interested company and the NCI. This information 
will include forms necessary for examining, and applying for license 
to, existing relevant patents and patent applications. Under the 
Collaborative Research and Development Agreement (CRADA), the 
industrial collaborator may obtain an option to negotiate a license to 
government patent rights to inventions arising under the CRADA.

DATES: Interested parties should notify this office in writing no later 
than sixty (60) days from the date of this announcement in the Federal 
Register. Respondents will then be provided an additional, sixty (60) 
days for the filing of formal proposals.

SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development 
Agreements'' or ``CRADA'' means the anticipated joint agreement to be 
entered into by NCI pursuant to the Federal Technology Transfer Act of 
1986 and Executive Order 12591 of October 10, 1987 to collaborate on 
the specific research project described below. The Division of Cancer 
Biology, Diagnosis and Centers (DCBDC) of NCI is seeking to develop a 
collaborative relationship with a major pharmaceutical company with the 
following aims:
    (1) Optimizing peptide and peptidomimetic activity in vitro and in 
vivo;
    (2) preclinical development of the synthetic peptides and mimetics; 
and
    (3) clinical studies as warranted.
    A family of related peptides have been synthesized based on the 
Type I repeats of human thrombospondin that bind to heparin or related 
sulfated glycoconjugates with high affinity. The peptides differ from 
previously described heparin-binding peptides in that they do not 
require basic amino acid residues for binding to heparin. The peptides 
are potent inhibitors of interactions of heparin, heparan sulfate 
proteoglycans, or related sulfated glycoconjugates with adhesion 
molecules, growth factors, cells and some heparin-dependent enzymes. 
The lack of charge should be advantageous in formulating pharmaceutical 
agents based on these peptides for efficient delivery to their sites of 
action. Stable analogs of the peptides have been synthesized with 
increased potency and specificity. The high potency of these 
peptidomimetics should allow much smaller amounts of the compound to be 
administered and thus may reduce risks of toxicity and generation of 
immune responses against the compounds.
    The peptides and mimetics have several defined activities: (a) 
Inhibition of binding of several adhesive proteins and growth factors 
to heparin and heparan sulfate proteoglycans; (b) inhibition of 
adhesive protein binding to tumor and endothelial cells; (c) promotion 
of tumor and endothelial cell adhesion on peptide coated substrates; 
and (d) modulation of tumor and endothelial cell growth and chemotaxis 
in response to basic fibroblast growth factor and some other growth 
factors in vitro and tumor growth in vivo.
    Preclinical studies are in progress to characterize the activities 
of these peptides in modulating tumor growth, metastasis, and invasion, 
and in inhibiting angiogenesis. Studies will also investigate potential 
use of the peptides to treat other diseases associated with angiogenic 
responses and as inhibitors of pathogen [[Page 4630]] interactions with 
sulfated glycoconjugates on host cells.
    The role of the Division of Cancer Biology, Diagnosis and Centers 
(DCBDC) of the National Cancer Institute (NCI) under the CRADA will 
include the following:
    1. The government will continue preclinical development of the 
peptides and mimetics as inhibitors of tumor growth and metastasis in 
vitro and in vivo. Data from these studies will be provided to the 
pharmaceutical company and evaluated jointly.
    2. The government will provide available data and expertise in 
structure-function relationships and conformational analysis of the 
active peptides and peptidomimetics. These data will be evaluated 
jointly in order to assess an efficient research path.
    3. As appropriate, the government will initiate collaborative 
clinical trials under its extramural clinical trials network, thus 
ensuring the clinical evaluation of the compounds.
    4. Relevant Patent rights are available for licensing through the 
Office of Technology Transfer, NIH. For further information contact: 
Ms. Carol Lavrich, Technology Licensing Specialist., Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Rockville, Maryland 20852-3804. (301) 496-7735 (ext. 287), 
Fax (301) 402-0220. There is no deadline by which license applications 
must be received. See 35 U.S.C. 207 and 37 C.F.R. Part 404.
    The role of the successful pharmaceutical company under the CRADA 
will include the following:
    1. Prepare and characterize GMP quality nonmetabolizable, analogs 
(as determined by both parties) of the active peptides and provide 
these to the DCBDC, NCI for characterization as angiogenesis and 
metastasis inhibitors.
    2. Provide funds for preclinical development of the peptides in 
vitro and for screening activities in appropriate animal models.
    3. Collaborate in the planning and support for clinical development 
leading to FDA approval and marketing.
    Criteria for choosing the pharmaceutical company include the 
following:
    1. Experience in preclinical and clinical drug development.
    2. Experience and ability to produce, package, market, and 
distribute pharmaceutical products in the United States.
    3. A willingness to cooperate with the Public Health Service in the 
collection, evaluation, publication, and maintenance of data from 
clinical trials of investigational agents.
    4. A willingness to cost share in the development of heparin 
binding peptides as outlined above. This includes acquisition of 
material and synthesis of heparin binding peptides and/or 
peptidomimetics in adequate amounts as needed for future clinical 
trials and marketing.
    5. An agreement to be bound by the DHHS rules involving human and 
animal subjects.
    6. The aggressiveness of the development plan, including the 
appropriateness of milestones and deadlines for preclinical and 
clinical development.
    7. Provisions for equitable distribution of patent rights to any 
inventions arising under the CRADA. Generally the rights of ownership 
are retained by the organization which is the employer of the inventor, 
with (1) an irrevocable, non-exclusive, royalty-free license to the 
Government (when a company employee is the sole inventor) or (2) an 
option to negotiate an exclusive or non-exclusive license to the 
company on terms that are appropriate (when a Government employee is 
the sole inventor).

    Dated: December 22, 1994.
Karen Maurey,
Acting Director, Office of Technology Development, National Cancer 
Institute, National Institutes of Health.
[FR Doc. 95-1665 Filed 1-23-95; 8:45 am]
BILLING CODE 4140-01-P