[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
