[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7049-7050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2494]


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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.

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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.

Integrase Inhibitors for the Treatment of Retroviral Infection 
Including Human Immunodeficiency Virus-1

    Description of Technology: Available for licensing and commercial 
development are stilbenedisulfonic acid derivatives for treatment of 
human immunodeficiency virus-1 (HIV-1) and other retroviral infections. 
Current HIV-1 therapeutic treatments target the viral protease and 
reverse transcriptase enzymes, which are essential for retroviral 
infection. However, these drugs often have limitations due to drug 
resistant variants, which render drugs ineffective. Additionally, such 
drugs are often toxic when administered in combination therapies. Thus, 
efficacious inhibitors of retroviral infection that are devoid of 
toxicity are presently needed.
    The subject invention describes stilbenedisulfonic acid 
derivatives, which target the integrase enzyme of retroviruses. Similar 
to protease and reverse transcriptase activity, integrase function is 
essential for retroviral infection. Integrase catalyzes integration of 
reverse transcribed viral DNA into a host cell's genome. For this 
reason, integrase is considered a rational therapeutic target for HIV-1 
infection. Further, integrase is a favorable target because the enzyme 
has no human cellular counterpart, which could interact with a 
potential integrase inhibitor and cause harmful side effects. Recent 
clinical data with an integrase inhibitor from Merck shows impressive 
clinical activity. The Merck compound is different from the current 
invention and is projected for FDA approval mid 2007. Thus, the subject 
invention is valuable for safe and effective treatment of HIV-1 and 
other retroviral infections.
    Application: Treatment of HIV infection.
    Development Status: The technology is ready for use in drug 
discovery and development.
    Inventors: Yves Pommier (NCI), Elena Semenova (NCI), Christophe 
Marchand (NCI).
    Patent Status: U.S. Provisional Application No. 60/849,718 filed 04 
Oct 2006 (HHS Reference No. E-264-2006/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; [email protected].

Broadly Cross-Reactive Neutralizing Antibodies Against Human 
Immunodeficiency Virus Selected by ENV-CD4-CO-Receptor Complexes

    Description of Technology: This invention provides a novel anti-HIV 
human monoclonal antibody named X5. This antibody demonstrates promise 
over conventional anti-HIV antibodies because the X5 antibody exhibits 
a unique binding activity compared to its counterparts. It has been 
established that the initial stage of HIV-1 entry into cells is 
mediated by a complex between the viral envelope glycoprotein (Env) 
such as gp120-gp41, a receptor CD4 and a co-receptor CCR5. The X5 
antibody binds to an epitope on gp120 that is induced by interaction 
between gp120 and the receptor CD4 and enhanced by the co-receptor 
CCR5. The X5 antibody also shows strong activity at very low levels (in 
the range from 0.0001-0.1 Mg/ml concentration is dependent on the 
isolate). Because it is a human antibody, it can be administered 
directly into patients so that it is an ideal candidate for clinical 
trials. It also can be easily produced because it was obtained by 
screening of phage display libraries and its sequence is known. 
Finally, since it has neutralized all virus envelope glycoproteins, 
including those from primary isolates of different clades, the epitope 
is highly conserved and resistance is unlikely to develop. Therefore, 
this antibody and/or its derivatives including fusion proteins with CD4 
are good candidates for clinical development.
    Additional information on the current research in Dr. Dimitrov's 
laboratory may be found at http://www-lecb.ncifcrf.gov/dimitrov/dimitrov.html.
    Applications: Antibody for HIV research, diagnostics and 
therapeutic development.
    Development Status: Preclinical data is available at this time.
    Inventors: Dimiter Dimitrov (NCI), Xiadong Xiao (NCI), Yuuei Shu 
(NCI), Sanjay Phogat (NIAID), et al.
    Patent Status: Patent Cooperation Treaty Serial No. PCT/US02/33165 
filed 16 Oct 2002; National Stage Filing in United States, India, 
Canada, Australia, Europe (HHS Reference No. E-130-2001/0).
    Availability: Available for licensing and commercial development, 
excluding the field of use of the development of the PEGylated X5, 
PEGylated X5 derivatives, mutants of PEGylated X5 or a derivative.
    Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; [email protected].
    Collaborative Research Opportunity: The NCI Center for Cancer 
Research Nanobiology Program (CCRNP) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize antibodies for 
HIV research, diagnostics and therapeutic development. Please contact 
John D. Hewes, Ph.D. at (301)

[[Page 7050]]

435-3121 or [email protected] for more information.

    Dated: February 2, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-2494 Filed 2-13-07; 8:45 am]
BILLING CODE 4140-01-P