[Federal Register Volume 60, Number 79 (Tuesday, April 25, 1995)]
[Notices]
[Pages 20278-20279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Cancer Institute: Opportunity for a Clinical Trial
Cooperative Research and Development Agreement (Clinical Trial
``CRADA'') for the Scientific and Commercial Development of the Signal
Transduction Inhibitor, ``CAI'', as an Anticancer Agent
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice.
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SUMMARY: The Department of Health and Human Services (DHHS) seeks a
pharmaceutical company which can effectively pursue the clinical
development of the signal transduction inhibitor, carboxyamide-amino
triazole (``CAI'', NSC 609974), for the treatment and/or prevention of
cancer. The National Cancer Institute has data suggesting that CAI may
have potential for the treatment and prevention of cancer. The selected
sponsor will be awarded a CRADA for the co-development of this agent
with the National Cancer Institute.
ADDRESSES: Questions about this opportunity may be addressed to Mark W.
Noel, Office of Technology Development, NCI, Building 31/Room 4A51,
9000 Rockville Pike, Bethesda, Maryland 20892, (301) 496-0477,
facsimile (301) 402-2117, from whom further information including a
summary copy of the preclinical and clinical data may be obtained.
DATES: 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 June 25, 1995. Respondents will
then be provided an additional 60 days for the filing of formal
proposals.
SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development
Agreement'' 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 present opportunity
will be for a Clinical Trial CRADA. The Clinical Trial CRADA is a
modification of the standard NIH Model Agreement wherein additional
language has been drafted to enable the Collaborator to access and
utilitize clinical trial data.
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 CAI 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.
CAI is a novel chemically defined compound which has shown
promising antitumor activity in several preclinical trials. The drug is
under patent to Merck & Co., Inc. (U.S. Patent 4,590,201). The use of
CAI in a method of treating peritoneal carcinomatosis of solid tumors
is claimed in U.S. Patent 5,132,315 assigned to the Dept. of Health and
Human Services. A method for the detection and quantitation of CAI
levels in blood is claimed in U.S. Patent 5,405,782 which is also
assigned to the Dept. of Health and Human Services. Its use in the
treatment of cancer in patients with a surgically excised tumor with a
high probability of metastasis and its use in treatment of cancers
involving the transportation of individual cells to other tissue from a
metastasizing tumor are claimed in U.S. Patent 5,045,543 (assigned to
Merck & Co. Inc). The Clinical Trial CRADA will allow a pharmaceutical
company to provide resources, in collaboration with the NCI, for the
continuing preclinical and clinical development work for this agent and
its eventual commercialization. Merck & Co.'s patent rights will be
available for licensing on terms to be mutually agreed upon by Merck
and the selected Collaborator. Similarly, the Government will make its
relevant intellectual property rights available for licensing to the
Collaborator.
Based on the promising data obtained from the ongoing Phase I
clinical trials, there is a need to obtain greater quantities of CAI
and to continue clinical development of this agent. The NCI is
interested in establishing a Clinical Trial CRADA with a pharmaceutical
company to assist in the continuing development of CAI. The government
will provide all relevant available expertise and information to date
and will jointly pursue new trials as required giving the
pharmaceutical company exclusive rights to all preclinical and clinical
data for regulatory approval and its New Drug Application (NDA). The
successful pharmaceutical company will provide the necessary quantities
of drug plus the necessary financial and organizational support to
complete further development of CAI to establish clinical efficacy and
possible commercial status.
The expected duration of the CRADA will be three (3) to five (5)
years.
The role of the National Cancer Institute, includes the following:
1. The government has data for the bulk production of clinical
grade CAI. The successful pharmaceutical company will be allowed access
to this data.
2. The government will provide data concerning pharmaceutical
manufacturing and controls, including dosage form development data for
the finished product.
3. The government will allow the pharmaceutical company to review
and cross-file the NCI's IND.
4. The government will make the NCI's IND proprietary under such
circumstances and make the IND available (exclusively) to the
pharmaceutical company.
5. The government will continue the clinical development of this
compound under its clinical trials network in coordination with the
pharmaceutical company.
6. Relevant Government intellectual property rights are available
for licensing through the Office of Technology Transfer, National
Institutes of Health. For further information contact Jack Spiegel,
Office of Technology Transfer, National Institutes of Health, Box OTT,
Bethesda, MD 20892; (301) 496-7735; facsimile (301) 402-0220.
[[Page 20279]]
The role of Merck & Co. under the CRADA will include the following:
1. Participate in the selection of the CRADA collaborator and in
the development of the CRADA Research Plan.
2. Provide for the licensing of Merck intellectual property rights
to the selected Collaborator as necessary for the clinical development
and commercialization of CAI as an anti-cancer agent.
The role of the successful pharmaceutical company under the CRADA
will include the following:
1. Provide plans to independently secure future continuing supplies
of GMP produced and formulated material to assure continued
collaborative clinical development of CAI.
2. Provide funds to supplement the clinical trials support
contracts and offer any other necessary support to the NCI for
continued collaborative clinical development of this compound. This
includes both financial support as well as personnel for data
management and clinical care.
3. Provide planning and support for clinical development leading to
FDA approval for marketing.
Criteria for choosing the pharmaceutical company include its
demonstrated experience and commitment to the following:
1. Experience in preclinical and clinical drug development.
2. Experience and ability to produce, package, market and
distribute pharmaceutical products.
3. Experience in the monitoring, evaluation and interpretation of
the data from investigational agent clinical studies under an IND.
4. A willingness to cooperate with the NCI in the collection,
evaluation, publication and maintaining of data from clinical trials of
investigational agents.
5. The provision of adequate quantities of GMP produced and
formulated CAI as needed for clinical development of this agent for the
specified field of use to be determined upon mutual agreement of the
parties.
6. Provide defined financial and personnel support for the clinical
trials to be mutually agreed upon.
7. An agreement to be bound by the DHHS rules involving human and
animal subjects.
8. The aggressiveness of the development plan, including the
appropriateness of milestones and deadlines for preclinical and
clinical development.
9. Provisions for equitable distribution of patent rights to any
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 (when
a company employee(s) is (are) the sole inventor(s)) or (2) an option
to negotiate an exclusive or nonexclusive license to the company on
terms that are appropriate (when the Government employee(s) is (are)
the sole inventor(s) or where a joint invention arises).
Dated: April 13, 1995.
Thomas D. Mays,
Director, Office of Technology Development, OD, NCI.
[FR Doc. 95-10109 Filed 4-24-95; 8:45 am]
BILLING CODE 4140-01-P
