[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Pages 48395-48396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20560]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies 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

[[Page 48396]]

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.

Antibodies That Specifically Recognize SUMO-Conjugated Proteins

Dr. Mary Dasso (NICHD).
U.S. Provisional Application Serial No. 60/438,685 filed 08 Jan 2003 
(DHHS Reference No. E-066-2002/0-US-01).
Licensing Contact: Marlene Shinn-Astor; 301/435-4426; 
[email protected]

    SUMO-1 is an ubiquitin-like heat shock protein that can be 
covalently conjugated to other proteins through an isopeptide linkage. 
This technology describes polyclonal antibodies that recognize SUMO-1 
conjugated proteins, including conjugated RanGAP1. These antibodies 
could be used as a diagnostic tool to test for diseases that contain 
SUMO-1 mis-regulation with further development. It is also foreseen 
that they could be used in large-scale screening of small molecule 
libraries to find compounds capable of either inhibiting or enhancing 
the SUMO-1 conjugation pathway.

Modulators of Nuclear Hormone Receptor Activity: Novel Compounds, 
Diverse Applications for Infectious Diseases, Including Anthrax (B. 
anthracis)

E. M. Sternberg (NIMH), J. I. Webster (NIMH), L. H. Tonelli (NIMH), S. 
H. Leppla (NIAID), and M. Maoyeri (NIAID).
DHHS Reference No. E-247-2002/0-US-01 filed 18 October 2002.
Licensing Contact: Peter Soukas; 301/435-4646; [email protected].

    Technology summary and benefits: Nuclear hormones such as 
glucocorticoids dampen inflammatory responses, and thus provide 
protection to mammals against inflammatory disease and septic shock. 
The Anthrax lethal factor represses nuclear hormone receptor activity, 
and thus may contribute to the infectious agent causing even more 
damage to the host. This observation can be exploited to find new means 
of studying and interfering with the normal function of nuclear hormone 
receptors. Scientists at NIH have shown that under the appropriate 
conditions, these molecules can be used to modulate the activity of 
various nuclear hormone receptors. Identifying useful agents that 
modify these important receptors can provide relief in several human 
disorders such as inflammation, autoimmune disorders, arthritis, 
malignancies, shock and hypertension.
    Long-term potential applications: This invention provides novel 
agents that can interfere with the action of nuclear hormone receptors. 
It is well known that malfunction or overdrive of these receptors can 
lead to a number of diseases such as enhanced inflammation; worse 
sequelae of infection including shock; diabetes; hypertension and 
steroid resistance. Hence a means of controlling or fine-tuning the 
activity of these receptors can be of great benefit. Current means of 
affecting steroid receptor activity are accompanied by undesirable 
side-effects. Since the conditions for which these treatments are 
sought tend to be chronic, there is a critical need for safer drugs 
that will have manageable side-effects.
    Uniqueness or innovativeness of technology: The observation that 
the lethal factor from Anthrax has a striking effect on the activity of 
nuclear hormone receptors opens up new routes to controlling their 
activity. The means of action of this repressor is sufficiently 
different from known modulators of hormone receptors (i.e., the 
classical antagonists). For instance, the repression of receptor 
activity is non-competitive, and does not affect hormone binding or DNA 
binding. Also, the efficacy of nuclear hormone receptor repression by 
Anthrax lethal factor is sufficiently high that the pharmacological 
effect of this molecule is seen at vanishingly small concentrations. 
Taken together, these attributes may satisfy some of the golden rules 
of drug development such as the uniqueness or novelty of the agent's 
structure, a low threshold for activity, high level of sophistication 
and knowledge in the field of enquiry, and the leeway to further refine 
the molecule by rational means.
    Stage of Development: In vitro studies have been completed, and a 
limited number of animal studies have been carried out.

Method for the Treatment of Multiple Sclerosis

Roland Martin et al. (NINDS).
U.S. Provisional Application Serial No. 60/393,021 filed 28 Jun 2002 
(DHHS Reference No. E-143-2002/0-US-01), PCT/US02/38290 filed 27 Nov 
2002 (DHHS Reference No. E-143-2002/0-PCT-02), U.S. Patent Application 
filed 27 Jun 2003 (DHHS Reference No. E-143-2002/0-US-03), and PCT/
US03/20428 filed 27 Jun 2003 (DHHS Reference No. E-143-2002/0-PCT-04).
Licensing Contact: Catherine Joyce 301/435-5031; e-mail: 
[email protected].

    The invention relates to the discovery that humanized antibodies to 
the interleukin-2 receptor (IL-2R) such as (daclizumab) are effective 
in treating multiple sclerosis (MS). In particular, it has been 
discovered that patients who have failed to respond to therapy with 
interferon-beta show dramatic improvement when treated with daclizumab, 
with patients showing both a reduction in the total number of lesions 
and cessation of appearance of new lesions during the treatment period. 
Daclizumab is effective both in combination with interferon-beta and 
alone.
    The above-mentioned invention is available for licensing on an 
exclusive or non-exclusive basis.

    Dated: August 4, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 03-20560 Filed 8-12-03; 8:45 am]
BILLING CODE 4140-01-P