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Notice

National Cancer Institute; Steroid Derivatives with Paclitaxel-Like Activity

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An opportunity is available for a Cooperative Research and Development Agreement (CRADA) for the purpose of collaborating with the Screening Technology Branch, National Cancer Institute (STB, NCI) on further research and development of U.S. government-owned technology encompassed within U.S. Provisional Patent Application Serial No. 60/161,533, entitled “B-Homoestra-1,3,5(10)-trienes as Modulators of Tubulin Polymerization.”

AGENCY:

National Cancer Institute, National Institutes of Health, PHS, DHHS.

ACTION:

Notice of opportunity for cooperative research and development (CRADA).

SUMMARY:

Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended by the National Technology Transfer and Advancement Act of 1995), 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 Cooperative Research and Development Agreement (CRADA) with a pharmaceutical or biotechnology company to develop new drugs and therapeutic methods based on screening pre-existing steroid libraries from the collaborator for paclitaxel-like activities and/or screening steroid derivatives from a directed synthetic effort by the collaborator to produce more active paclitaxel-like compounds. The CRADA would have an expected duration of one (1) to five (5) years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products or methods of treatment that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA and which are subject of the CRADA Research Plan, and can apply for background licenses to the existing patent described above, subject to any pre-existing licenses already issued for other fields of use. Dr. Mark Cushman of Purdue University is a co-inventor on the U.S. Provisional Patent Application Serial No. 60/161,533, entitled “B-Homoestra-1,3,5(10)-trienes as Modulators of Tubulin Polymerization.” Therefore, it is anticipated that negotiations with Purdue University regarding their interest in the original patent application would be required if the potential CRADA collaborator required exclusive rights to the technology encompassed by this patent.

ADDRESSES:

Proposals and questions about this CRADA opportunity may be addressed to Dr. Bjarne Gabrielsen, Technology Development & Commercialization Branch, National Cancer Institute-Frederick Cancer Research & Development Center, Fairview Center, Room 502, Frederick, MD 21701 (phone: 301-846-5465, fax: 301-846-6820).

Scientific inquiries should be directed to Dr. Ernest Hamel, Senior Investigator, Screening Technology Branch, National Cancer Institute-Frederick Cancer Research & Development Center, Bldg. 469, Rm. 237, Frederick, MD 21702-1201 [phone: (301)-846-1678; fax: (301)-846-6014]; e-mail: hamele@dc37a.nci.nih.gov

EFFECTIVE DATE:

Inquiries regarding CRADA proposals and scientific matters may be forwarded at any time. Confidential preliminary CRADA proposals, preferably two pages or less, must be submitted to the NCI on or before June 20, 2000. Guidelines for preparing final CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest.

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SUPPLEMENTARY INFORMATION:

Technology Available

DHHS scientists within the STB, NCI, in a collaboration with the laboratory of Dr. Mark Cushman, Purdue University, relating to steroid molecules that interact with tubulin, have discovered a subgroup of steroid derivatives that have paclitaxel-like effects on tubulin. Instead of inhibiting tubulin assembly, the new class induces formation of hyperstable microtubules and hypernucleates tubulin assembly. However, the most active molecules so far discovered are considerably less active than paclitaxel and have limited cytotoxicity. Details are in U.S. Provisional Patent Application Serial No. 60/161,533 available under an appropriate Confidential Disclosure Agreement.

Technology Sought

Accordingly, DHHS now seeks collaborative arrangements for the screening, joint elucidation, evaluation and development of novel compounds and methods to produce more active paclitaxel-like compounds. For collaboration with the commercial sector, a Cooperative Research and Development Agreement (CRADA) will be established to provide for equitable distribution of intellectual property rights developed under the CRADA. CRADA aims will include rapid publication of research results as well as full and timely exploitation of any commercial opportunities.

NCI and Collaborator Responsibilities

The role of the laboratory of Dr. Hamel, STB, NCI in this CRADA will include, but not be limited to:

1. Providing intellectual, scientific, and technical expertise and experience to the research project.

2. Undertake evaluation of compounds in their interactions with purified tubulin and examination of effects of promising compounds on cell growth and morphology. It is anticipated that such screening efforts would also reveal compounds that inhibit tubulin assembly and that have significant inhibitory effects on angiogenesis.

3. Planning research studies and interpreting research results.

4. Publishing research results.

The role of the CRADA Collaborator may include, but not be limited to:

1. Providing significant intellectual, scientific, and technical expertise or experience to the research project such as lead optimization, organic synthetic efforts directed toward new analogs, derivatives.

2. Planning research studies and interpreting research results.

3. Providing technical expertise and/or financial support for CRADA-related research as outlined in the CRADA Research Plan.

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Selection criteria for choosing the CRADA Collaborator may include, but not be limited to:

1. The ability to collaborate with NCI on further research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to on-going research and development.

2. Expertise and experience in the following areas: preclinical research and drug development of steroidal, paclitaxel-like compounds; ability to perform appropriate chemical synthetic efforts to support structure/activity (SAR) studies, lead-optimization, drug candidate selection and development.

3. The demonstration of adequate resources to perform the research, development and commercialization of this technology (e.g., facilities, personnel and expertise) and accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborator's proposal.

4. The willingness to commit best effort and demonstrated resources to the research, development and commercialization of this technology.

5. The demonstration of expertise in the commercial development, production, marketing and sales of products related to this area of technology.

6. The willingness to cooperate with the National Cancer Institute in the timely publication of research results.

7. The agreement to be bound by the appropriate DHHS regulations relating to human subjects, and all PHS policies relating to the use and care of laboratory animals.

8. The willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any. These provisions govern the equitable distribution of patent rights to CRADA inventions. Generally, the rights of ownership are retained by the organization that is the employer of the inventor, with (1) the grant of a license for research and other Government purposes to the Government when the CRADA Collaborator's employee is the sole inventor, or (2) the grant of an option to elect an exclusive or non-exclusive license to the CRADA Collaborator when the Government employee is the sole inventor.

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Dated: March 7, 2000.

Kathleen Sybert,

Chief, Technology Development & Commercialization Branch, National Cancer Institute, National Institutes of Health.

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[FR Doc. 00-7051 Filed 3-21-00; 8:45 am]

BILLING CODE 4140-01-P