[Federal Register Volume 69, Number 181 (Monday, September 20, 2004)]
[Notices]
[Page 56229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21120]


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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 invention listed below is owned by an agency of the U.S. 
Government and is 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 listed 
below may be obtained by contacting Marlene Shinn-Astor, J.D., 
Technology Licensing Specialist, at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301/435-4426; fax: 301/402-
0220; e-mail: [email protected].

Evaluative Means for Detecting Inflammatory Reactivity

Esther M. Sternberg et al. (NIMH)

U.S. Patent 5,209,920 issued 11 May 1993 (DHHS Reference No. E-289-
1988/2-US-01)
    Dysregulations of neuroendocrine stress responses have profound 
effects on the immune system that are associated with various 
autoimmune/inflammatory disorders such as rheumatoid arthritis (RA) and 
psychiatric conditions such as depression and post traumatic stress 
disorder (PTSD). Inventors from NIMH had previously found that the 
hypothalamic pituitary adrenal (HPA) hormonal axis, which acts as a 
regulatory checkpoint between the neuroendocrine and the immune system, 
is dysregulated in such disorders. Further research now shows that in 
particular, dysregulation in the secretion of corticotropin releasing 
hormone (CRH) from the hypothalamus contributes to these conditions. 
Therefore, the HPA axis, CRH and CRH receptors can serve as major 
targets for drug development and diagnosis of these diseases.
    This patent covers the development of therapeutics and diagnostics 
for autoimmune/inflammatory diseases that affect millions of people. 
The patent proposes the use of a wide variety of classes of HPA axis 
active agents to treat inflammatory illnesses. The patent claims 
specifically predict that an HPA agonist can be used to treat 
arthritis. The usefulness and applicability of the patent also extends 
to the CRH receptor antagonists (e.g., CRH R1 antagonist, Antalarmin) 
that are now being developed for the treatment of depression and PTSD. 
Diagnostically, this invention can be used to identify individual 
susceptibility to autoimmune/inflammatory diseases. Testing of the HPA 
axis to predict and select responders and non-responders to HPA 
agonists and CRH receptor antagonists could provide an approach for 
safe application of such therapeutic agents to a larger proportion of 
the target population. For example a subject found to have a low HPA 
axis responsiveness based upon the methods as described in the patent, 
would be predicted to have a greater risk of developing adrenal 
insufficiency while being treated with this new class of drugs. Such 
individuals could then be treated accordingly to prevent adverse events 
while on CRH antagonist therapy.
    Currently, such predictive approaches are not used routinely in 
clinical settings. The potential of this invention to diagnose and 
treat certain diseases in a predictive fashion makes it an excellent 
candidate for simultaneously developing therapeutics and the associated 
diagnostics. Antalarmin--which is being developed through an NIH 
initiative--has passed preliminary assessment at the FDA and will soon 
be in phase I human trials. The inventors found Antalarmin to be 
effective in reducing clinical arthritis score in rats by 50%, possibly 
through its blockade of CRH's peripheral pro-inflammatory effects.
    Given that an estimated 43 million people in the United States 
alone have arthritis or other rheumatic conditions, and that this 
number is expected to reach 60 million by 2020, this patent holds great 
potential in further development of therapeutics and diagnostics for 
autoimmune/inflammatory diseases.

    Dated: September 14, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-21120 Filed 9-17-04; 8:45 am]
BILLING CODE 4140-01-P