[Federal Register Volume 72, Number 111 (Monday, June 11, 2007)]
[Notices]
[Pages 32126-32128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11195]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

[[Page 32127]]

A Sensitive, High Throughput Pseudovirus-Based Papillomavirus 
Neutralization Assay for HPV 16 and HPV 18

    Description of Technology: This invention is a research tool for 
measuring protective antibody responses against Human Papilloma Viruses 
(HPV). Sensitive high-throughput neutralization assays, based upon 
pseudoviruses carrying a secreted alkaline phosphatase (SEAP) reporter 
gene, were developed and validated by the inventors for HPV 16, HPV 18, 
and bovine papillomavirus 1 (BPV1). In a 96-well plate format, the 
assay was reproducible and appears to be as sensitive as, but more 
type-specific than, a standard papillomavirus-like particle (VLP)-based 
enzyme-linked immunosorbent assay (ELISA). The SEAP pseudovirus-based 
neutralization assay should be a practical method for quantifying 
potentially protective antibody responses in HPV natural history and 
prophylactic vaccine studies.
    Inventors: John T. Schiller (NCI), Douglas R. Lowy (NCI), 
Christopher Buck (NCI), Diana V. Pastrana (NCI), et al.
    Publication: The assay is further described in Pastrana et al., 
``Reactivity of human sera in a sensitive, high-throughput pseudovirus-
based papillomavirus neutralization assay for HPV16 and HPV18,'' 
Virology. 2004 Apr 10;321(2):205-216.
    Patent Status: HHS Reference No. E-137-2004/0--Research Material.
    Licensing Status: This assay is available nonexclusively through a 
biological materials license.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].

Development of a Novel High Throughput Assay To Measure Cell-Infection 
With Vaccinia Strains Expressing Reporter Genes

    Description of Technology: Critical to developing a vaccine against 
viral infections is an assay to measure the neutralizing antibody 
present in blood of vaccine recipients. The currently available tests 
are labor intensive and require 5-6 days to complete. The inventors 
have designed a high throughput vaccinia neutralization assay, which 
offers several advantages over the assays that are currently used. It 
is completed in as little as 24 hours, it is sensitive, highly 
reproducible, requires only 50 [mu]l of plasma and uses automated 
readout. This assay is based on the use of recombinant vaccinia virus 
(vSC56) expressing a bacterial gene coding for the enzyme b-
galactosidase (b-Gal) under the control of a synthetic early/late 
promotor. Another recombinant virus expressing an inducible reporter 
gene (Luciferase) is also being tested in neutralization assay. These 
assays may be of value in the clinical trials of new smallpox vaccines, 
for evaluations of new vaccinia immunoglobulin (VIG) and anti-viral 
agents under development. The technology itself may be adapted for 
construction of neutralization assays for other viruses and 
intracellular pathogens.
    Inventor: Hana Golding (FDA).
    Publications:
    1. J Manischewitz et al. Development of a novel vaccinia-
neutralization assay based on reporter-gene expression. J Infect Dis. 
2003 Aug 1;188(3):440-448.
    2. Y Edghill-Smith et al. Modeling a safer smallpox vaccination 
regimen, for human immunodeficiency virus type 1-infected patients, in 
immunocompromised macques. J Infect Dis. 2003 Oct 15;188(8):1181-1191.
    3. JC Goldsmith et al. Intravenous immunoglobulin products contain 
neutralizing antibodies to vaccinia. Vox Sang. 2004 Feb;86(2):125-129.
    4. Y Edghill-Smith et al. Smallpox vaccine does not protect 
macaques with AIDS from a lethal monkeypox virus challenge. J Infect 
Dis. 2005 Feb 1;191(3):372-381.
    5. Y Edghill-Smith et al. Smallpox vaccine-induced antibodies are 
necessary and sufficient for protection against monkeypox virus. Nat 
Med. 2005 Jul;11(7):740-747.
    6. CA Meseda et al. Enhanced immunogenicity and protective effect 
conferred by vaccination with combinations of modified vaccinia Ankara 
and licensed smallpox vaccine Dryvax in a mouse model. Virology. 2005 
Sep 1;339(2):164-175.
    7. KH Waibel et al. Clinical and immunological comparison of 
smallpox vaccination administered to the outer versus the inner upper 
arms of vaccinia-na[iuml]ve adults. Clin Infect Dis. 2006 Feb 
15;42(4):e16-20.
    8. JM Heraud et al. Subunit recombinant vaccine protects against 
monkeypox . J.Immunol. 2006 Aug 15;177(4):2552-2564.
    9. VL Kan et al. Durable neutralizing antibodies after remote 
smallpox vaccination among adults with and without HIV infection. AIDS. 
2007 Feb 19;21(4):521-524.
    Patent Status: U.S. Provisional Patent Application 60/429,767 filed 
27 Nov 2002 (HHS Reference No. E-300-2002/0-US-01); PCT Application No. 
PCT/US03/37677 filed 24 Nov 2003, which published as WO 2004/053454 on 
24 Jun 2004 (HHS Reference No. E-300-2002/0-PCT-02); U.S. Patent 
Application No. 10/536,860 filed 06 Jan 2006 (HHS Reference No. E-300-
2002/0-US-05).
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The CBER/FDA Laboratory of 
Retrovirus Research is seeking statements of capability or interest 
from parties interested in collaborative research to further develop or 
evaluate novel anti-vaccinia agents including monoclonal antibodies and 
vaccines. Please contact Hana Golding at Tel: 301-827-0784 or E-mail: 
[email protected] for more information.

Vectors for Delivering Viral and Oncogenic Inhibitors

    Description of Technology: The invention concerns cell transduction 
vectors which are capable of inhibiting viral replication in cells 
transduced with these vectors, and which also are capable of inhibiting 
the growth of cancer cells. Specifically, these expressions vectors 
produce protective genes which interfere with viral replication. These 
genes are tightly regulated by HIV-1 Tat and Rev proteins, which if 
produced after infection can induce expression of the protective genes. 
The vectors contain either a single gene (delta-gag), or a combination 
of two different genes (delta-gag and RNAse) which interfere with HIV-1 
replication at different stages of the HIV-1 life cycle. Following 
transduction of target cells, the mRNA for the protective genes is 
incorporated into the newly budding virion along with the viral genomic 
mRNA. Following infection of neighboring cells, the mRNA for the 
protective gene can be reverse transcribed and integrated into these 
cells, thereby increasing the proportion of cells containing the 
protective gene.
    In providing protection against viral replication, the vectors 
embodied in this invention could be used in gene therapy against HIV 
and against other viral diseases. In addition, the vectors could be 
used for introducing specific genes into neoplastic cells and thereby 
be effective in treating cancer and other diseases.
    Inventors: Susanna M. Rybak, Andrea Cara, Gabriella L. Gusella, 
Dianne L. Newton (NCI).
    Patent Status: U.S. Patent No. 6,953,687 issued 11 Oct 2005 (HHS 
Reference No. E-117-1996/0-US-07); U.S. Patent Application No. 11/
043,858 filed 24 Jan 2005 (HHS Reference No. E-117-1996/0-US-08).

[[Page 32128]]

    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].

    Dated: June 4, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-11195 Filed 6-8-07; 8:45 am]
BILLING CODE 4140-01-P