[Federal Register Volume 59, Number 228 (Tuesday, November 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29315]


[[Page Unknown]]

[Federal Register: November 29, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health; HHS.

ACTION: Notice.

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    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 filed on selected inventions to extend market coverage 
for U.S. 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 Specialist at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804 (telephone 301/496-7735; fax 301/402-0220). A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications. Issued patents may be obtained from 
the Commissioner of Patents, U.S. Patent and Trademark Office, 
Washington, DC 20231.

A Method for the Treatment of Acquired Immunodeficiency Syndrome

Pollard, H.B., Pollard, B.S. (NIDDK)
Filed 21 Dec 93
Serial No. 08/050,370
Licensing Contact: Steven Ferguson

    This invention involves a novel apparatus for treating HIV 
infection, the etiologic agent of AIDS, that offers an inexpensive, 
nontoxic therapy for this disease. Presently, the only approved 
treatment for HIV infection is AZT, which does not work in all AIDS 
patients and eventually becomes toxic to bone marrow. An experimental 
approach to the treatment of AIDS employs neutralizing antibodies to 
the envelope glycoproteins (gp120 or gp160). Because HIV mutates 
rapidly, the neutralizing antibody approach has not proven effective. 
Since binding to CD4 receptors on immune cells and other cells is the 
method by which HIV infects and destroys the immune system, another 
experimental approach has been to use cell-free CD4 to bind to the 
gp120 of the virus and thereby protect cells from viral attachment. 
However, the problem with this approach is that it requires large 
amounts of continuous doses of CD4. In addition, CD4 binds to Class II 
major histocompatibility antigens on cells, further compromising the 
immune system. This newly developed apparatus uses CD4 receptor (rCD4) 
molecules immobilized on beads inside a porous chamber. The holes in 
the chamber allow the HIV virion to enter the chamber but are small 
enough to prevent the entry of cells containing the CD4 receptor. The 
chamber is placed within the peritoneal cavity or on-line in the blood 
stream. When all the rCD4 molecules on the beads are occupied by HIV, 
the chamber is replaced. A membrane lytic agent also can be attached to 
the beads, so that once the virion is bound, it is promptly destroyed.

Diagnostic Agents for Human Herpesvirus 7 and Infected Cells

Berneman, Z.N., Gallo, R.C., Lusso, P., Reitz, M.S. (NCI)
Filed 26 Jul 93
Serial No. 08/098,941 (CIP of 07/971,102)
Licensing Contact: Steven Ferguson

    Development of a convenient source of human herpesvirus 7 (HHV-7) 
will make it significantly easier to diagnose and detect this type of 
viral infection. Human herpesviruses cause a variety of diseases, 
including skin lesions, mononucleosis, chicken pox, and disseminated 
multisystem infections in immune-compromised individuals. Although the 
recently identified HHV-7 is not yet associated with disease, it shares 
sequence homology with HHV-6 and other viruses that do cause disease; 
therefore, it is essential to be able to differentiate between these 
viruses. Previously, it has been difficult to develop a test for HHV-7 
because the virus can only infect certain kinds of cells that do not 
propagate the virus well. Nucleic acid sequences derived from the 
amplification of HHV-7 have been isolated and purified. This invention 
includes primers and probes for detection of HHV-7 infection or for the 
amplification of HHV-7. A vector is also included for transforming a 
unique cell line that provides a ready source of virus particles and 
viral proteins for diagnostic and potential therapeutic uses.

HIV-2 or its Viral Components as Therapeutic Agents in the Treatment 
and/or Prevention of HIV-1 Infection

Rappaport, J.F., Arya, S., Klotman, P.E. (NIDR)
Filed 15 Nov 93
Serial No. 08/153,117
Licensing Contact: Steven Ferguson

    The HIV-2 viral proteins may offer a new and better method for 
treating and/or inhibiting HIV-1 infection. Although the most widely 
used method for treating HIV-1 infection, AZT, slows the progression of 
infection, it has toxic side effects, and the virus often eventually 
becomes resistant to its effects. Other methods that have been 
developed for preventing HIV infection have not been successful to 
date. Recently, it has been shown that protein subunits of HIV-2, which 
are related to HIV-1 but appear to be less pathogenic, can interfere 
with HIV-1 infection and replication. This invention offers a gene 
encoding one HIV-2 protein, in particular, that effectively inhibits 
HIV-1 LTR response, which is essential for its replication. The HIV-1 
LTR-inhibiting protein can be used to treat individuals with HIV-1 
infection, or a gene encoding the protein can be inserted into T-cells 
taken from an HIV-1-infected individual. The T-cells can then be put 
back into the patient in order to inhibit further HIV-1 replication in 
the patient.

Octopamine Receptor

Venter, J.C., Fraser, C.M., McCombie, W.R. (NINDS)
Filed 8 Feb 94
Serial No. 08/194,338 (DIV of 07/676,174)
Licensing Contact: Arthur Cohn

    Receptors for octopamine--a transmitter, hormone, and 
neuromodulator in invertebrates such as arthropods and mollusks--are 
selectively blocked by mammalian   -adrenergic antagonists and 
agonists. A segment of the DNA molecule that encodes an octopamine 
receptor protein was isolated. The octopamine receptor is a member of 
the adrenergic/muscarinic/opsin family. Expression of the novel 
octopamine receptor cDNA in mammalian cells can be used to study the 
isolated receptor. The octopamine receptor may also be useful in 
screening, designing, and testing pharmaceuticals and insecticides 
targeted to the receptor. This invention reduces the need for animals 
in early phases of related drug research and provides a cost-effective, 
selective alternative to current drug-screening methods.

Biologically Active ATP Derivatives

Jacobson, K., Fischer, B., Maillard, M.C. (NIDDK)
Filed 8 Mar 94
Serial No. 08/207,870
Licensing Contact: Arthur Cohn

    This is a novel class of biologically active ATP analogs that may 
be useful in the treatment of a variety of conditions, including septic 
shock. ATP functions, among other things, as a neurotransmitter, and 
its effects are mediated by a certain class of receptors called 
P2. The P2 receptor is widely distributed throughout the body 
and the central nervous system. These novel ATP derivatives have been 
shown to have more activity on certain subsets of P2 receptors 
than does ATP. Thus, they may be valuable as selective stimulators or 
inhibitors of tissues enriched in these P2 receptor subsets. In 
particular, these ATP derivatives may be effective in the treatment of 
septic shock and brain seizures as well as in the enhancement of 
learning and memory.

In Vivo Assays for Inhibitors of IgE-Mediated Allergic Responses

Kinet, J.P., Koller, B. (NIAID)
Filed 1 Dec 93
Serial No. 08/160,502
Licensing Contact: Laurence Hyman

    An in vivo biological assay developed for inhibitors of 
immunoglobulin E (IgE)-mediated allergic responses offers an important 
new tool for studying allergic responses as well as for developing 
treatments for allergies. Many lines of evidence have led to the 
concept that the interaction between IgE and mast cells and basophils 
is the primary effector pathway in allergic responses. Thus, inhibitors 
of this interaction offer the prospect of effectively reducing the 
severity of many allergic reactions; however, the search for inhibitors 
of allergic responses has been hampered by the lack of accurate, 
inexpensive, and rapid assays. This application provides mice 
``humanized'' to express portions of the human high affinity IgE 
receptor, and in which the corresponding portions of the mouse receptor 
are non-functional. Such mice can be used to quickly and economically 
screen for agents that can inhibit the release of histamine in the 
presence of an allergic stimulus.

Simian T-Cell Leukemia/Lymphotropic Virus Type Pan-P

Franchini, G., Gallo, R.C., Markham, P., Giri, A. (NCI)
Filed 22 Apr 94
Serial No. 08/231,526
Licensing Contact: Steven Ferguson

    A new type of T-cell lymphotropic virus, designated STLVpan-p 
or STLV-II, has been isolated and cultured. The virus, which was 
isolated from the peripheral blood mononuclear cells of a colony of 
captive pygmy chimpanzees, was able to immortalize several co-cultures 
of human cord blood mononuclear cells. These immortalized co-cultures 
became T-cell lines expressing CD4+, CD8+, and DR+ phenotypes of mature 
activated T-cells. Synthetic nucleic acid sequences from this virus 
that are capable of directing the production of recombinant proteins 
have also been developed, which may be used as probes to detect the 
presence of T-cell lymphotropic viruses in biological samples 
(including human samples) or may be used in vaccine development.

Retinoids Can Increase the Potency of Anti-Cancer Immunotoxins

Wu, Y.N., Youle, R.J. (NINDS)
Filed 6 May 94
Serial No. 08/238,997
Licensing Contact: Laurence Hyman

    A unique method of potentiating the effect of anti-cancer 
immunotoxins has been developed, thus offering to significantly improve 
the treatment of a number of cancers as well as autoimmune diseases. 
Prolonged treatment of human cancers with classical methods such as 
radiation and chemotherapy, or a combination of both, may cause greater 
damage than the underlying disease because healthy tissue is often 
damaged along with diseased tissue. More recently, immunotherapy has 
emerged as a new and promising therapy for treating cancer because it 
employs monoclonal antibodies specific for tumor cells coupled to 
protein toxins. Thus, cancer cells are selectively targeted for 
destruction. These immunotoxins are being examined in numerous clinical 
trials for the treatment of cancer and autoimmune diseases. However, 
often the protein toxin coupled to the monoclonal antibody does not 
pass as readily into the cytosol of the target cell as does the native 
protein toxin. This invention improves the effectiveness of such 
immunotoxins by employing retinoic acid, which disrupts the Golgi 
apparatus of the target cell and increases the cytosolic routing of 
specific protein toxins. Also included in this invention is an in vitro 
method for assessing the ability of a retinoid to potentiate the 
activity of immunotoxins.

Pteridine Nucleotide Analogs as Fluorescent DNA Probes

Hawkins, M.E., Pfleiderer, W., Davis, M.D., Balis, F. (NCI)
Filed 18 May 94
Serial No. 08/245,923
Licensing Contact: Robert Benson

    The invention concerns a series of pteridine deoxyribosides which 
are highly fluorescent and resemble purine nucleotides in structure and 
properties. The pteridine nucleotide analogs can be site-specifically 
incorporated into oligonucleotides using conventional DNA synthesis 
techniques. The fluorescence quantum yields of the pteridine nucleotide 
analogs are highly dependent on their physicochemical environment, thus 
lending themselves to homogeneous assays. They have been used in a real 
time assay of the HIV integrase enzyme. Other uses foreseen are as 
labels for DNA probes and PCR primers and for investigating protein-DNA 
interactions. The claims include derivatives of the pteridine 
nucleotide analogs useful as starting materials for oligonucleotide 
synthesis and oligonucleotides comprising the pteridine nucleotide 
analogs.

    Dated: November 16, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-29315 Filed 11-28-94; 8:45 am]
BILLING CODE 4140-01-P