01-15602. Cooperative Research and Development Agreement (CRADA)

AGENCY:

Centers for Disease Control and Prevention (CDC), HHS.

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) is seeking a CRADA partner for collaboration to examine the use of anti-substance P antibodies and/or anti-substance P F(ab)′2 antibody fragments to prevent and/or treat an inflammatory response mediated by substance P associated with respiratory viral infection (particularly respiratory syncytial virus [RSV]). Anti-substance P antibody treatment would be used in combination with agents for anti-viral treatment (e.g., Ribavirin, palivizumab, and RSV fusion inhibitors) to ameliorate substance P-mediated inflammation and disease pathogenesis.

Because CRADAs are designed to facilitate the development of scientific and technologic knowledge into useful, marketable products, a great deal of freedom is given to Federal agencies in implementing collaborative research. CDC may accept staff, facilities, equipment, supplies, and money from the other participants in a CRADA; CDC may provide staff, facilities, equipment, and supplies to the project. There is a single restriction in this exchange: CDC MAY NOT PROVIDE FUNDS to the other participants in a CRADA.

DATES:

This opportunity is available until July 23, 2001. Respondents may be provided a longer period of time to furnish additional information if CDC finds this necessary.

ADDRESSES:

The responses must be made to: Lisa Blake-DiSpigna, Technology Transfer Coordinator, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical: Ralph A. Tripp, Ph.D., Respiratory and Enteric Viruses, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE., Mailstop G-09, Atlanta, GA 30333, telephone [phone].

Business: Lisa Blake-DiSpigna, Technology Transfer Coordinator, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 30333, telephone [phone].

SUPPLEMENTARY INFORMATION:

The goal of this CRADA is to seek a partner for collaboration to examine the development and use of anti-substance P antibodies and/or anti-SP F(ab)'2 antibody fragments to prevent and/or treat an inflammatory response mediated by substance P that is associated with respiratory viral infection (particularly RSV). The methods comprise the administration to the subject of a pharmaceutically effective amount of anti-SP antibodies or anti-SP F(ab)'2 antibody fragments to inhibit the activity of endogenous SP in the subject. Anti-SP antibody or anti-SP F(ab)'2 antibody treatment will be used in combination with anti-viral drugs and anti-viral reagents to inhibit the activity of endogenous SP in the subject so as to reduce the level of cytokine/chemokine-based inflammation and pulmonary cell infiltration and alter the disease course.

Respondents should provide evidence of expertise in the development and evaluation of anti-viral drugs and anti-viral reagents, evidence of experience in animal models systems including non-human primate models, commercialization of anti-viral drugs and anti-viral reagents, and supporting data (e.g., publications, proficiency testing, certifications, resumes, etc.) of qualifications for the principle investigator who would be involved in the CRADA. The respondent will develop the final research plan in collaboration with CDC.

Applicant submissions will be judged according to the following criteria:

1. Expertise in development and evaluation of anti-viral drugs and anti-viral reagents;

2. Expertise in evaluation of anti-viral drugs, reagents and anti-viral treatments in animal model systems including non-human primates;

3. Evidence of scientific credibility. The company has the capability of bringing the product to fruition, in part determined by past accomplishments with similar products, and/or that the company has published related studies in peer-reviewed journals;

4. Evidence of commitment and ability to develop anti-substance P monoclonal antibodies for use with anti-viral drugs, anti-viral reagents or antiviral treatments; and

5. Evidence of an existing infrastructure to commercialize successful technologies.

This CRADA is proposed and implemented under the 1986 Federal Technology Transfer Act: Public Law 99-502.

Dated: June 14, 2001.

Thena M. Durham,

Director, Executive Secretariat, Office of the Director, Centers for Disease Control and Prevention (CDC).