[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