E6-4611. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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: [phone]; fax: [phone]. 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; [e-mail].

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 [e-mail] 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; [e-mail].

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 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 [e-mail] 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; [e-mail].

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 [e-mail] 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; [e-mail].

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 [e-mail] 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.