[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30343-30344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing: 
Cyanovirin-based Topical Microbicides for Prevention of Sexual 
Transmission of HIV

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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[[Page 30344]]

SUMMARY: The U.S. National Institutes of Health seeks exclusive or non-
exclusive licensee(s) for certain aspects of technology encompassed 
within the following U.S. (and corresponding international) patent and 
patent application: 5,843,882 issued December 1, 1998, entitled 
``Antiviral Proteins and Peptides'', and Serial No. 08/969,378 filed 
November 13, 1997, entitled ``Methods of Using Cyanovirins to Inhibit 
Viral Infectivity'' (in accordance with 35 U.S.C. 207 and 37 CFR Part 
404).
    More specifically, licensee(s)is (are) sought to develop and 
commercialize microbicidal compositions, formulations, devices and/or 
methods directly incorporating the unique, HIV-inactivating protein, 
cyanovirin-N (CV-N), for topical use to prevent sexual transmission of 
HIV infection and disease.

ADDRESSES: Inquiries concerning this licensing opportunity should be 
directed to Dr. Carol Salata, Technology Licensing Specialist, Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; telephone: 301-496-7735 
ext. 232; fax: 301-402-0220; e-mail: [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
the patent application.

SUPPLEMENTARY INFORMATION: The development of an effective anti-Hiv 
topical microbicide, especially a female-controlled, vaginal 
microbicide, has been deemed an urgent global priority by numerous 
international agencies, incuding the World Health Organization, the 
U.S. Department of Health and Human Services, the National Institute of 
Allergy and Infectious Diseases, and others.
    Cyanovirin-N (CV-N) is a unique, 101 amino acid protein 
discovered,\1\ by U.S. government scientists, as a constituent of a 
cultured cyanobacterium, Nostoc ellipsosporum. CV-N has subsequently 
been produced recombinantly in E. coli. \3\ Both the sequence \1\ and 
the 3-D solution structure \2\ of CV-N are unprecedented.
    CV-N potently and irreversibly inactivates diverse primary strains 
of HIV-1, including M-tropic forms involved in sexual transmission of 
HIV, as well as T-tropic and dual-tropic forms; CV-N also blocks cell-
to-cell transmission of HIV infection.\1\ CV-N is directly virucidal, 
interacting in an unusual manner with the viral envelope, apparently 
binding with extremely high affinity to poorly immunogenic epitopes on 
gp120.1, 3
    CV-N was benign in vivo when tested in the rabbit vaginal toxicity/
irritancy model, and was not cytotoxic in vitro against human immune 
cells and lactobacilli (unpublished). CV-N is readily soluble in 
aqueous media, is remarkably resistant to physicochemical 
degradation,\1\ and, is amendable to very large-scale production by a 
variety of genetic engineering approaches.

Selected References

1. Boyd, M.R., Gustafson, K.R., McMahon, J.B., Shoemaker, R.H., 
O'Keefe, B.R., Mori, T., Gulakowski, R.J., Wu, L., Rivera, M., 
Laurencot, C.M., Cardellina, J.H. II, Buckheit, R.W. Jr., Nara, 
P.L., Pannel, L.K., Sowder, R.C. II, Henderson, L.E.: Discovery of 
cyanovirin-N, a novel human immunodeficiency virus-inactivating 
protein that binds viral surface envelope glycoprotein gp120; 
potential applications to microbicide development. Antimicrob. 
Agents Chemother. 41: 1521-1530, 1997.
2. Bewley, C.A., Gustafson, K.R., Boyd, M.R., Covell, D.G., Bax, A., 
Clore, G.M., Gronenborn, A.M.: Solution structure of cyanovirin-N, a 
potent HIV-inactivating protein. Nature Struct. Biol. 5: 571-578, 
1998.
3. Mori, T., Gustafson, K.R., Pannell, L.K., Shoemaker, R.H., Wu, 
L., McMahon, J.B., Boyd, M.R.: Recombinant production of cyanovirin-
N, a potent HIV (human immunodeficiency virus)-inactivating protein 
derived from a cultured cyanobacterium. Protein Expr. Purif. 12: 
151-158, 1998.
4. Esser, M.T., Mori, T., Mondor, I., Sattentau, Q., Dey, B., 
Berger, E.A., Boyd, M.R., Lifson, J.D.: Cyanovirin-N binds to gp120 
to interfere with CD4-dependent HIV-1 virion binding, infectivity, 
and fusion, but does not affect the CD4 binding site on gp120 or 
soluble CD4 induced conformational changes in gp120. J. Virol. 
73:4360-4371, 1999.

    Dated: May 28, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 99-14375 Filed 6-4-99; 8:45 am]
BILLING CODE 4140-01-M