[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35500-35501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12534]


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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.

Orally Active Derivatives of 1,3,5(10)-estratriene

    Description of Technology: The utility of estrogenic substances in 
the practice of medicine is well documented. Estrogens may be used for 
the replacement of the natural hormone estradiol in hypogonadism, and 
following the removal of the ovaries or cessation of ovarian activity 
during menopause. They are also widely employed as a component of oral 
contraceptives. However, orally-active synthetic estrogens are 
associated with a number of side effects, such as: Enhanced risk of 
endometrial carcinoma; induction of malignant carcinoma, especially in 
the cervix, breast, vagina and liver; promotion of gallbladder disease, 
thromboembolic and thrombotic diseases, myocardial infarction, hepatic 
adenoma, elevated blood pressure, and hypercalcemia; and reduced 
glucose tolerance.
    The NIH announces a new family of novel, active estrogens that are 
nitrate esters of estradiol. These nitrate esters possess enhanced 
estrogenic activity following oral administration and lack a 17-ethynyl 
alcohol, which has been implicated in many side effects attributed to 
other synthetic estrogens. It is anticipated that these esters could be 
used in all instances where estrogen is prescribed as a treatment.
    Applications: Hormone replacement therapies; Oral contraceptives.
    Market: The hormone replacement market exceeds one billion dollars 
per year, and the oral contraceptive market is more than three billion 
dollars per year.
    Development Status: Early stage.
    Inventors: Hyun K. Kim et al. (NICHD).
    Patent Status: U.S. Patent 5,554,603 issued 10 Sep 1996 (HHS 
Reference No. E-137-1993/0-US-01); Foreign counterparts in Australia, 
Canada, Japan, and Europe.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301/435-4426; 
[email protected].

Methods of Inducing Immune Tolerance Using Immunotoxins

    Description of Invention: The invention concerns immunotoxins and 
methods of using the immunotoxins for the treatment of rejection 
response in a patient, including graft-versus-host disease and 
transplantation of organs, tissues and cells into a host. In a specific 
embodiment of the invention, the transplant involves pancreatic islet 
cells. The immunotoxins are targeted via an antibody that is specific 
to T cells. This allows the specific ablation of resting T cells, 
resulting in an accentuation of immune tolerizing responses and an 
increased tolerance to transplants and grafts. The toxin portion of the 
immunotoxin is genetically engineered to maintain bioactivity when 
recombinantly produced in Pichia pastoris. Data are available in 
transgenic animals expressing human CD3[egr] which

[[Page 35501]]

supports the effects of the immunotoxin against T cells.
    Applications: Use of immunotoxins decreases T cell population, 
allowing greater host immune tolerance of transplants and grafts; 
Specific method for increasing immune tolerance to pancreatic islet 
transplants.
    Advantages: Specificity of the immunotoxin avoids the killing of 
other cells, reducing side-effects associated with other mechanisms of 
treatment (X-ray and cyclophosphamide) such as infection and induced 
malignancy; A GMP production process for the immunotoxin has already 
been successfully implemented.
    Benefits: New methods and compositions with limited side-effects 
have the potential to revolutionize treatment of transplant/graft 
recipients; provides an opportunity to capture a significant market 
share for the millions of people who require transplants/grafts.
    Inventors: David Neville et al. (NIMH).
    Patent Status: U.S. Patent No. 5,167,956 issued 01 Dec 1992 (HHS 
Reference No. E-012-1991/0-US-01); U.S. Patent No. 5,762,927 issued 09 
Jun 1998 (HHS Reference No. E-012-1991/4-US-02); U.S. Patent No. 
6,103,235 issued 15 Aug 2000 (HHS Reference No. E-012-1991/7-US-01); 
U.S. Patent No. 7,125,553 issued 24 Oct 2006 (HHS Reference No. E-012-
1991/7-US-02); U.S. Patent Application No. 09/810,999 filed 16 Mar 
2001, which published as U.S. 2001/0024645 on 27 Sep 2001, Allowed (HHS 
Reference No. E-059-1998/0-US-02); International Patent Application No. 
PCT/US00/10253 filed 14 Apr 2000, which published as WO 00/61132 on 19 
Oct 2000 (HHS Reference E-168-1999/0-PCT-02); U.S. Patent No. 6,632,928 
issued 14 Oct 2003 (HHS Reference No. E-044-1997/0-US-07); U.S. Patent 
Application No. 10/435,567 filed 09 May 2003, which published as 2003/
0185825 on 02 Oct 2003 (HHS Reference No. E-044-1997/0-US-08); U.S. 
Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 
2004/0127682 on 01 Jul 2004 (HHS Reference No. E-044-1997/1-US-06); 
Foreign rights are also available.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: David A. Lambertson, PhD; 301/435-4632; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Mental Health, Laboratory of Molecular Biology, is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize methods of 
using the immunotoxins for the treatment of rejection response in a 
patient. Please contact David Neville at [email protected] for more 
information.

    Dated: June 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-12534 Filed 6-27-07; 8:45 am]
BILLING CODE 4140-01-P