[Federal Register Volume 71, Number 114 (Wednesday, June 14, 2006)]
[Notices]
[Pages 34377-34378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9302]


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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.

Generation of Regulatory T Cells for Immunotherapy

    Description of Technology: Abnormalities in immunoregulation are 
responsible for a wide variety of disorders such as autoimmune disease, 
chronic inflammatory diseases, and allergic diseases. These diseases 
include systemic lupus erythematosus, rheumatoid arthritis, type I 
diabetes mellitus, inflammatory bowel disease, multiple sclerosis, 
Crohn's disease and asthma. The defining event for induction of an 
immune-mediated disorder is the loss of T cell tolerance to self-
antigens, which is provided by regulatory T cells. Traditional methods 
for treating immune-mediated disorders involve the use of steroids or 
other immunosuppressive drugs, which have significant undesirable side 
effects.
    This invention provides methods for generating regulatory T cells 
by culturing CD4+CD25-T cells with autologous antigen-presenting cells 
(APCs) in the presence of the Th2 cytokines interleukin-4 (IL-4) and/or 
interleukin-13 (IL-13). Immunotherapy via this mechanism is anticipated 
to have a large number of potential therapeutic applications. Methods 
are also provided for treatment of

[[Page 34378]]

autoimmune disease or inflammation in a subject by administration of an 
IL-4 agonist, as well as methods of treating cancer by administration 
of an IL-4 antagonist.
    Applications: Therapeutic method for treatment of autoimmune 
disease or inflammation; Therapeutic method to prevent graft rejection 
in a transplant recipient; Therapeutic method for treatment of cancer; 
Diagnostic test for efficacy of an IL-4 antagonist in cancer treatment.
    Development Status: Early stage.
    Inventors: Peter E. Lipsky (NIAMS) et al.
    Publication: A Skapenko et al., ``The IL-4 receptor alpha-chain-
binding cytokines, IL-4 and IL-13, induce forkhead box P3-expressing 
CD25+CD4+ regulatory T cells from CD25-CD4+ precursors,'' J Immunol. 
(2005 Nov 1) 175(9):6107-6116.
    Patent Status: U.S. Provisional Application No. 60/728,475 filed 19 
Oct 2005 (HHS Reference No. E-010-2005/1-US-01).
    Licensing Status: This technology is available for exclusive, co-
exclusive, or nonexclusive licensing.
    Licensing Contact: Marlene K. Astor, JD, MS, MIP; 301/435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIAMS, Autoimmunity Branch, 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize a process for the generation of regulatory T cells for 
immunotherapy. Please contact Dr. Peter E Lipsky at 301/594-0596 or 
[email protected] for more information.

Method Evolved for Recognition of Thrombophilia (MERT): Clinical 
Predictive Genetic Test for Venous Thrombosis

    Description of Technology: Venous thrombosis (VT) is one of the 
leading causes of mortality and morbidity resulting in approximately 
300,000 hospitalizations and 50,000 fatalities per year in the United 
States with an incidence of 141 per 100,000 African-Americans, 104 per 
100,000 Caucasians and 21 per 100,000 Asian/Pacific Islanders. However, 
it is an avoidable disease if effective preventive measures such as 
early thromboprophylaxis are instituted.
    It is highly beneficial to estimate individual thrombotic risk to 
aid in development of individualized risk-adapted prophylaxis.
    Venous thrombosis is a multifactorial disorder and occurs as an 
outcome of a combination of environmental and genetic risk factors. In 
addition to well-established venous thrombosis associated acquired or 
environmental factors such as surgery, use of oral contraceptives and/
or hormone replacement therapy, trauma, bone fractures, prolonged 
immobilization, advanced age, previous thrombosis history, malignancy 
and pregnancy, genetic predisposition via a number of variably 
penetrant genetic mutations or polymorphisms impart an increased risk 
for venous thrombosis.
    In pregnant women, inherited thrombophilia can greatly increase the 
risk of adverse pregnancy outcomes such as miscarriages, intrauterine 
growth restriction, preeclampsia, placental abruption, or stillbirth as 
well as thrombosis during the recovery period after childbirth.
    In addition to the differences in the prevalence of venous 
thrombosis among ethnic groups, there are accumulating data revealing 
differences in genetic determinants among ethnic groups such as 
differences in susceptibility associated genes and even in sequence 
alterations of the same gene. Furthermore some of the mutations and 
polymorphisms are mainly restricted to the specific populations. Such 
examples are FV Leiden, prothrombin G20210A polymorphisms. Whereas FV 
Leiden and prothrombin G0210A polymorphisms are the most prevalent risk 
factors for venous thrombosis in Caucasians, the patients from ethic 
populations other than Caucasians exhibit no or very rare FV Leiden or 
prothrombin G20210A polymorphisms.
    This invention describes a highly-predictive genetic test to 
identify individuals with increased risk for venous thrombosis. It 
comprises a rapid, accurate and affordable genetic screen, utilizing 
genomic DNA microarray technology consisting of a combination of venous 
thrombosis associated mutations and polymorphisms that is applicable to 
diverse ethnic populations. Eight genes (antithrombin III, PC, PS, 
fibrinogen, factor V, prothrombin (factor II), MTHFR and ACE) are 
screened for the 143 known venous thrombosis-associated recurrent 
mutations and polymorphisms. This multi-gene test increases the 
predictive power for detection of genetic susceptibility to thrombosis 
over 20-fold compared to single-gene analysis, in multiple ethnic 
populations.
    Applications: (1) Rapid, cost-effective predictive test kit to 
identify asymptomatic individuals at risk for venous thrombosis in 
diverse ethnic populations; (2) Rapid, cost-effective predictive test 
kit to identify pregnant women at risk for thrombophilia-associated 
adverse pregnancy outcomes such as miscarriage, intrauterine growth 
restriction, preeclampsia, placental abruption, or stillbirth as well 
as postpartum thrombosis; (3) Provides reduction of the yearly 
incidence of venous thrombosis by early identification of individuals 
at inherited risk, allowing protection before they develop symptoms by 
instituting effective preventive measures, such as early 
thromboprophylaxis or even decisions such as avoiding the use of oral 
contraceptives or hormone replacement therapy; (4) Provides advantages 
over currently available plasma-based thrombophilia screening panel by 
avoiding underdetermination of anticoagulant protein deficient 
individuals or by avoiding high rates of false positivity; (5) Allows 
individualized management and anticoagulation treatment of patients 
according to inherited thrombophilia status.
    Market: (1) Individuals before or during exposure to situations 
that increase the risk of venous thrombosis, such as surgery, use of 
oral contraceptives and/or hormone replacement therapy, trauma, bone 
fractures, prolonged immobilization, long air journeys, advanced age, 
malignancy, or combinations thereof; (2) Pregnant women, or women who 
plan to become pregnant, as inherited thrombophilia is a significant 
risk factor for adverse pregnancy outcomes such as miscarriage, 
intrauterine growth restriction, preeclampsia, placental abruption, 
stillbirth and postpartum thrombotic events.
    Development Status: Validation stage.
    Inventors: Cigdem F. Dogulu, Owen M. Rennert, and Wai-Yee Chan 
(NICHD).
    Patent Status: PCT Application No. PCT/US2005/01419 filed 14 Jan 
2005, which published as WO 2005/071114A1 on 04 Aug 2005 (HHS Reference 
No. E-282-2003/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521; 
[email protected].

    Dated: June 8, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-9302 Filed 6-13-06; 8:45 am]
BILLING CODE 4140-01-P