Federal Register: April 9, 1999 (Volume 64, Number 68)NoticesPage 17400-17402From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr09ap99-76

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below are owned by agencies 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 filedon 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.

Electroacoustic Imaging Methods and Apparatus

Han Wen, Robert S. Balaban (NHLBI) Serial No. 60/104,823 filed30 Dec 98 Licensing Contact: John Fahner-Vihtelic; 301/496-7735 ext. 270; jf36z@nih.gov

Recently, an electroacoustic imaging apparatus and two electroacoustic imaging methods have been developed. The two methods are ``forward'' and ``reverse'' electroacoustic imaging which requires the application of a probing signal, and the detection and measurement of an induced signal to produce images. The electroacoustic apparatus offers the advantage of generating 2D and 3D images non-invasively. It can simultaneously image several contrast mechanisms, including the Hall effect, the thermoacoustic effect, and the electroaccoustic effect. Although this device uses a Piezoelectric transducer, fiberoptic acoustic sensors can also be substituted to take advantage of advances in acoustic wave detection technology. This technology is available for licensing opportunities.

Ultrasound Array and Electrode Array for Hall Effect Imaging

Han Wen, Robert S. Balaban (NHLBI) Serial No. 60/102,478 filed30 Sep 98 Licensing Contact: John Fahner-Vihtelic; 301/496-7735 ext. 270; jf36z@nih.gov

Recent developments in ultrasound probe design and ultrasound detector array technology have provided means for optimal ultrasound signal detection and 2D/3D image reconstruction in Hall Effect Imaging (HEI). The new developments include an electrode array, and an ultrasound array configured and controlled to provide rapid image acquisition with high contrast and definition. The electrode array contains split electrodes that control the direction of the electrical currents responsible for 2D/3D image generation. The ultrasound array contains shielded ultrasound sensors which overcome the problem of electromagnetically induced ultrasonic noise that interferes with data acquisition. In this design each element of the ultrasound array is connected to a commercially-available preamplifier which can be coupled to a separate channel of data acquisition circuitry, or digitizer that allows for digital data acquisition. This technology is available for licensing opportunities.

Human Cancer Antigen TRP2

M Parkhurst, Sa Rosenberg, Y Kawakami (NCI) Serial No. 60/105,577 filed26 Oct 98 Licensing Contact: Elaine Gese; 301/496-7056 ext. 282; e-mail: eg46t2nih.gov

The current invention embodies the identification of a nine amino acid peptide derived from the melanoma antigen known as tyrosinase- related protein 2 (TRP2). The TRP2 peptide is capable of stimulating cytotoxic T lymphocytes which specifically react with, and lyse, melanoma cells in the context of HLA-A0201. HLA-A0201 is the most common subtype of HLA-A2, which is the most commonly expressed family of Class I MHC molecules in melanoma patients in the U.S. It therefore is believed that the TRP2 peptide, along or in combination with HLA-A2- specific peptides from other melanoma antigens, could be used as an immunotherpeutic vaccine for the prevention and treatment of melanoma in a large percentage of patients having that form of cancer. In addition, the peptide could prove useful as a diagnostic reagent for evaluating the efficacy of immunization in these patients.

[Page 17401]Spectral Cloning--An Innovative Technical and Conceptual Approach to the Cloning and Characterization of Every Chromosomal Aberration in Cancer Samples

Ilan R. Kirsch (NCI) DHHS Reference No. E-216-97/1 filed29 Jun 98; PCT/US98/13557 Licensing Contact: Manja Blazer; 301/496-7056 ext. 224; e-mail: mb379e@nih.gov

The invention described in this application provides methods and related apparatus permitting the detection and characterization of all chromosomal abnormalities found in a biological sample such as leukemia, carcinoma or sarcoma.

Cancer is a disease caused by genetic instability. Genetic Instability is revealed as the DNA point mutations, insertions, deletions, amplifications, and translocations that distinguish a tumor from the normal tissue from which it arose. Identification of these DNA alterations associated with tumor development provides insight into: (a) the process by which the DNA was altered; and (b) the genes themselves whose alteration contributes to malignant transformation. Thus, cloning and characterizing chromosomal translocations (one particularly dramatic example of genetic instability) gives insight into:

<bullet> Cancer etiology

<bullet> Interaction of a gene with the environment and therefore preventive strategies

<bullet> Structural reconfigurations of DNA that accompany malignant transformation and therefore potential utility for early diagnosis

<bullet> Cellular functions and pathways that are targets for malignant transformation and therefore identify potential candidates for anti-cancer therapies.

Novel Thioesters and Uses Thereof

Jim A. Turpin, Yongsheng Song, John K. Inman, Mingjun Huang, Anders Wallqvist, Andrew Maynard, David G. Covell, William G. Rice, Ettore Appella (NCI & NIAID) Serial No. 60/089, 842 filed19 Jun 1998 Licensing Contact: J. Peter Kim; 301/496-7056 ext. 264; e-mail: jk141n@nih.gov

The human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS). Drug-resistance is a critical factor contributing to the gradual loss of clinical benefit to treatments for HIV infection. Accordingly, combination therapies have further evolved to address the mutating resistance of HIV. However, there has been great concern regarding the apparent growing resistance of HIV strains to current therapies.

The present invention provides for a novel family of thioesters and uses thereof. These thioesters are capable of inactivating viruses by a variety of mechanisms, particularly by complexing with metal ion- complexing zinc fingers. The invention further provides for methods for inactivating a virus, such as the human immunodeficiency virus (HIV), using these compounds, and thereby also inhibiting transmission of the virus.

Methods and Compositions for Making Dendritic Cells From Expanded Populations of Monocytes and for Activating T Cells

EL Nelson, SL Strobl (NCI) DHHS Reference No. E-181-97/1 filed20 May 98 (PCT Application PCT/ US98/10311), based upon U.S. Provisional Patent Application 60/047, 348 Licensing Contact: Elaine Gese; 301/496-7056 ext. 282; e-mail: eg46t@nih.gov

The current invention embodies methods for easily generating large numbers of dendritic cells from IL-3 cultured populations of monocytes. Dendritic cells are potent antigen presenting cells which are capable of mediating a variety of cell-mediated (T cell) immune responses, and therefore are clearly of value for use in immunotherapy. In addition, dendritic cells are quite rare in peripheral blood and therefore cannot be isolated in sufficient numbers of use in therapeutic applications. This method significantly enhances the generation of human dendritic cells from peripheral blood monocytes making possible more extensive use and study of this unique cell population and thereby clearly serving to overcome these difficulties. In addition to the methods embodied in the invention, ex vivo therapeutic applications, pharmaceutical compositions and diagnostic methods are claimed, as are cell cultures for making the dendritic cells.

Method and Composition for Detecting Dihydropyrimidine Dehydrogenase Splicing Mutations

Frank J. Gonzalez, Pedro Fernandez-Salguero (NCI) DHHS Reference No. E-157-94/1 filed20 Mar 96 Licensing Contact: Girish Barua; 301/496-7056 ext. 263; e-mail: gb18t@nih.gov

Dihydropyrimidine dehydrogenase (DPD) is the first and rate limiting enzyme in the three step metabolic pathway of the catabolism of thymidine and uracil. In mammals, this pathway is the route for synthesis of beta-alanine. DPD can be considered an enzyme that is expressed in most cells, but has been studied extensively in liver, lymphocytes, and the CNS. DPD is responsible for the metabolism of fluoropyrimidine drugs, such as the much used chemotherapeutic agent 5- fluorouracil.

The invention covers isolated nucleic acids that code for DP. It also includes nucleic acids that code for a DPD polypeptide that specifically binds to an antibody generated against an immunogen consisting of DPD polypeptide and its amino acid sequence. Also claimed are methods for determining whether a cancer patient is at risk of a toxic reaction to 5-fluorouracil. The methods involve analyzing DPD DNA or mRNA a sample from the patient to determine the amount of intact DPD nucleic acid.

Peptidomimetic Inhibitors of Cathepsin D and Plasmepsins I and II

Pavel Majer, Jack Collins, Sergei V. Gulnik, John W. Erickson (NCI) Serial No. 08/603,737 filed20 Feb 96; U.S. Patent 5,849,691 issued 15 Dec 98 Licensing Contact: Girish Barua; 301/496-7056 ext. 263; e-mail: gb18t@nih.gov

The invention relates to the design and synthesis of linear and cyclic inhibitors of cathespin D and plasmepsins I and II. The present invention also relates to the uses of these inhibitors for inhibiting invasion and metastasis of cancerous cells. It also covers the use of cathepsin D and plasmepsin I and II inhibitors for the prevention and treatment of Alzheimer's disease and malaria.

Transframe Peptide Inhibitor of Viral Protease

John Louis Medabalimi (NIDDK) Serial No. 08/539,432 filed05 Oct 95; U.S. Patent No. 5,872,210, issued 16 Feb 99 Licensing Contact: J. Peter Kim; 301/496-7056 ext. 264; e-mail: jk141n@nih.gov

The present invention is directed to small, water-soluble peptides isolated from a native virus inhibitory sequence. The native peptide is involved in the step-wise autocatalytic maturation of the virally encoded protease in a pH dependent manner. the isolated peptide and its derivatives also inhibit the mature protease. The peptides and its derivatives may be used to treat virally

[Page 17402]infected cells, in preparing vaccine formulations, in generating clinically relevant antibodies and anti-idiotypic antibodies, and generating a screening assay or a kit that can be used to identify other similarly acting protease inhibitors.

Dated: April 1, 1999. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer.

FR Doc. 99-8875Filed4-8-99; 8:45 amBILLING CODE 4140-01-M