[Federal Register Volume 71, Number 61 (Thursday, March 30, 2006)]
[Notices]
[Pages 16169-16170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4611]


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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.

Immunogenic Peptides and Methods of Use for Treating and Preventing 
Cancer

Jay A. Berzofsky et al. (NCI)
U.S. Provisional Application No. 60/773,319 filed 03 Nov 2005 (HHS 
Reference No. E-312-2005/0-US-01)
Licensing Contact: John Stansberry; 301/435-5236; 
[email protected].

    Rhabdomyosarcoma is a malignant (cancerous), soft tissue tumor 
found in children. The most common sites are the structures of the head 
and neck, the urogenital tract, and the arms or legs. The inventors 
have discovered an epitope that is created by a chromosomal 
translocation that occurs in about 80% of alveolar rhabdomyosarcoma and 
can elicit a human cytotoxic T lymphocytes (CTL) response in 
individuals who express HLA-B7.
    Many tumors express mutated tumor associated antigens that often 
contain T-lymphocyte epitopes. However, the immune system often remains 
incapable of overtaking the growth potential of the malignant cells. 
Previous attempts to obtain protective and therapeutic anti-tumor 
immunity have been moderately successful (Dagher et al., Med Pediatr 
Oncol 38: 158-164 (2002) and Rodeberg et al., Cancer Immuno Immunother 
54: 526-534 (2005)). This present invention seeks to improve on 
previous attempts by providing more immunogenic peptides that bind to a 
Major Histocompatibility Complex (MHC) Class I molecule with higher 
affinity, and fusion proteins comprising at least one of the inventive 
immunogenic peptides. This discovery involves human T-cell responses to 
human tumors.
    The National Cancer Institute welcomes statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize NCI's technology related to methods 
of protective and therapeutic immunogenic peptides. Please contact Dr. 
Patrick Twomey at 301-496-0477 or [email protected] for more 
information.

Impaired Neuregulin1-Stimulated B Lymphoblast Migration as Diagnostic 
for Schizophrenia

Daniel Weinberger et al. (NIMH)
U.S. Provisional Application No. 60/735,353 filed 10 Nov 2005 (HHS 
Reference No. E-181-2005/1-US-01)
Licensing Contact: Norbert Pontzer; 301/435-5502; 
[email protected].

    Schizophrenia may be a neurodevelopmental disorder (Weinberger D.R. 
and Marenco S. in Schizophrenia as a neurodevelopmental disorder, 
Hirsch S., Weinberger D.R. (eds) Schizophrenia, 2nd ed., Blackwell 
Science: Oxford, UK, 2003 pp 326-348). Neuregulin1 (NRG1) plays a 
critical role in neuronal migration and maturation by interacting with 
ErbB tyrosine kinase receptors and linkage studies and genetically 
engineered animals have implicated NRG1-mediated signaling in the 
neuropathogenesis of schizophrenia. Although no technique is available 
to assess NRG1/ErbB mediated neural migration in living human brain, 
there is increasing recognition that neuronal cells and immune cells 
share many cellular and molecular mechanisms for cell migration and 
motility. These inventors showed NRG1 mediated chemotactic responses of 
B lymphocytes from schizophrenic patients are

[[Page 16170]]

significantly decreased compared to controls. If aberrant ErbB function 
during development is a cause of schizophrenia, and that aberrant ErbB 
function is expressed in peripheral blood cells throughout life, the 
assay should predict susceptibility to schizophrenia even before 
clinical symptoms are apparent.
    The NIMH Clinical Brain Disorders Branch is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the above 
technology. Please contact Suzanne L. Winfield at 
[email protected] for more information.

Treatment of Pulmonary Hypertension (PH) Using Nitrite Therapy

M. Gladwin (CC), R. Cannon (NHLBI), A. Schechter (NIDDK), C. Hunter 
(CC), R. Pluta (NINDS), E. Oldfield (NINDS) et al.
PCT Applications filed 09 Jul 2004 (priority date 9 July 2003): PCT/
US04/21985, International Publication No. WO 2005/007173, Publication 
Date 27 January 2005 [HHS Reference No. E-254-2003/2-PCT-01] and PCT/
US04/22232, International Publication No. WO 2005/004884, Publication 
Date 20 January 2005 [HHS E-254-2003/3-PCT-01]
Licensing Contact: Susan Carson, D.Phil.; 301/435-5020; 
[email protected].

    Pulmonary Hypertension (PH) occurs as a primary or idiopathic 
disease as well as secondary to a number of pulmonary and systemic 
diseases, such as neonatal PH and sickle cell disease. There is no cure 
for pulmonary hypertension, a nitric-oxide deficient state 
characterized by pulmonary vasoconstriction and systemic hypoxemia and 
therapies vary in efficacy and cost. Recent studies by NIH researchers 
and their collaborators provided evidence that the blood anion nitrite 
contributes to hypoxic vasodilation through a heme-based, nitric oxide 
(NO)-generating reaction with deoxyhemoglobin and potentially other 
heme proteins [Nature Medicine 2003 9:1498-1505]. These initial results 
indicate that sodium nitrite can be used as a potential cost-effective 
platform therapy for a wide variety of disease indications 
characterized broadly by constricted blood flow or hypoxia.
    These results have been further corroborated by more recent work in 
the neonatal lamb model for PH. Inhaled sodium nitrite delivered by 
aerosol to newborn lambs with hypoxic pulmonary hypertension elicited a 
rapid and sustained reduction (65%) in hypoxia-induced pulmonary 
hypertension. Pulmonary vasodilation elicited by aerosolized nitrite 
was deoxyhemoglobin- and pH-dependent and was associated with increased 
blood levels of iron-nitrosyl-hemoglobin. Notably, short term delivery 
of nitrite dissolved in saline through nebulization produced selective, 
sustained pulmonary vasodilation with no clinically significant 
increase in blood methemoglobin levels. [Nature Medicine 2004 10:1122-
1127]. This new, simple and cost-effective potential therapy for 
neonatal PH is available for licensing.
    Also available for licensing are claims directed to nitrite salt 
formulations associated with elevated blood pressure, decreased blood 
flow or hemolytic disease (HHS Ref. No. E-254-2003/2) as well as for 
the treatment of specific conditions including hepatic, cardiac or 
brain ischemia-reperfusion injury and other cardiovascular conditions 
[J. Clin. Invest. (2005) 115:1232-1240; JAMA (2005) 293:1477-1484] (HHS 
Ref. No. E-254-2003/3).
    The National Heart, Lung, and Blood Institute, Vascular Medicine 
Branch, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize a treatment of pulmonary hypertension (PH) using nitrite 
therapy. Please contact Dr. Mark Gladwin by phone at 301-435-2310 or by 
e-mail at [email protected] for more information.

Modified Growth Hormone

YP Loh, NX Cawley (both of NICHD), BJ Baum (NIDCR), and CR Snell
U.S. Patent Application No. 10/477,651 filed 14 Nov 2003 (HHS Reference 
No. E-184-2001/1-US-02) which is a 371 application of PCT/US02/15172 
filed 14 May 2002 and which claims priority to 60/290,836 filed 14 May 
2001
Licensing Contact: Susan S. Rucker; 301/435-4478; 
[email protected].

    This invention described and claimed in this patent application 
provides for an improved method for producing human growth hormone 
(hGH) in vitro or in vivo. In particular, the patent application 
describes compositions and methods which are based on a modified form 
of human growth hormone where the regulated secretory pathway (RSP) 
sorting signal has been modified to provide for the constitutive 
secretion of human growth hormone via the nonregulated secretory 
pathway (NRSP) in a mammalian cell. One particular modified hGH 
composition, has been demonstrated to be biologically active and able 
to be secreted into the bloodstream in an animal model providing proof-
of-concept. This invention can be applied to a non-invasive method of 
gene therapy to achieve sustained delivery of this therapeutic protein.
    The application has been published as WO 02/092619 (11/21/2002) and 
as 2004/0158046 A1 (08/12/2004). The work has also been published at 
Wang J, et al. Human Gene Therapy 16(5):571-83 (May 2005). Only U.S. 
Patent protection has been sought for this technology. There are no 
foreign counterpart patent applications.
    The NICHD Office of the Scientific Director is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the non-
invasive method of production and systemic delivery of growth hormone 
or other proteins for therapeutic purposes. Please contact Dr. Y. Peng 
Loh at 301/496-3239 or [email protected] for more information.

    Dated: March 21, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E6-4611 Filed 3-29-06; 8:45 am]
BILLING CODE 4140-01-P