[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)]
[Notices]
[Pages 24867-24870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11422]
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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, 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.
2,5-Diamino-3,4-Disubstituted-1,6-F-Diphenyhexane Isoteres Comprising
Benzamide, Sulfonamide and Anthranilamide Subunits and Methods Of Using
Same
Randad, R.S., Erickson, J.W. (NCI)
Filed 20 Dec 94
Serial No. 08/359,612
Licensing Contact: Robert Benson (301/496-7056 ext 267)
This invention concerns retroviral protease inhibitors which are
potential drugs for the treatment of HIV infection. The compounds of
the invention contain novel nonpeptidic and achiral substituents,
wherein achiral benzamide, sulfonamide and anthranilamide subunits are
introduced onto the 2,5-diamino-3,4-disubstituted-1,6-diphenylhexane
isostere core. The compounds are more resistant to viral and mammalian
protease degradation. The best compounds had a Ki (inhibition
constant) of less than 100 pM for HIV protease. CEM cells chronically
infected with HIV-1 were used to test anti-retroviral activity. The
concentrations needed to inhibit 50% of viral activity were on the
order of 5 nM. Therefore, these compounds compare favorably in their
anti-viral potency to the best HIV protease inhibitors currently in
clinical trials. [portfolio: Infectious Diseases--Therapeutics, anti-
virals, AIDS]
Conformationally Locked Nucleoside Analogs
Marquez, V.E., Rodriguez, J.B., Nicklaus, M.C., Barchi, J.J.
(NCI)
Filed 24 Sep 94
Serial No. 08/311,425 (CIP of 08/126,796)
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
Novel nucleoside analogues have been developed that may facilitate
structure-function analysis of anti-HIV compounds. Recently, there has
been intense interest in the design and use of nucleoside analogues
that can inhibit the replication of viruses such as HIV-1. The three-
dimensional conformation of such analogues has been implicated in their
ability to successfully inhibit viral replication; however, in the
past, it has been difficult to conduct structure-
[[Page 24868]] function analyses because the sugar part of the
nucleoside is flexible and the conformation often changes. These newly
developed nucleoside analoguess make such studies more feasible because
they employ cyclopropane-fused di-deoxynucleosides, which lock the
conformation of the sugar part of the molecule in place. [portfolio:
Internal Medicine--Miscellaneous]
Mammalian Bilirubin UDP-Glucoronosyltransferase Clones, and Methods for
Use Thereof
Owens, I., Ritter, J. (NICHD)
Filed 8 Sep 94
Serial No. 08/303,315 (CIP of 08/209,688, FWC of 07/639,453)
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
Liver transplantation is now the only treatment for Crigler-Najjar
Type I syndrome. Other hyperbilirubinemic syndromes are difficult and
expensive to diagnose. This cDNA clone encodes a mammalian bilirubin
UDP-glucoronosyltransferase. Applications include gene therapy for
patients with Crigler-Najjar Type I syndrome, a gene-based fetal
diagnostic probe for the syndrome, and diagnostic tools for other
hyperbilirubinemic syndromes such as Gilbert syndrome. [portfolio:
Internal Medicine--Miscellaneous]
Nucleotide and Deduced Amino Acid Sequences of the Envelope 1 Gene Of
51 Isolates Of Hepatitis C Virus and the Use Of Reagents Derived from
These Sequences in Diagnostic Methods and Vaccines
Bukh, J., Miller, R.H., Purcell, R.H. (NIAID)
Filed 15 Aug 94
Serial No. 08/290,665
Licensing Contact: Girish Barua (301/496-7735 ext 263)
The invention is in the field of hepatitis virology and relates to
complete nucleotide and deduced amino acid sequences of the envelope 1
(E1) gene of hepatitis C virus (HCV) isolates from around the world and
the grouping of these isolates into twelve distinct HCV genotypes. More
specifically, this invention covers oligonucleotides, peptides and
recombinant proteins derived from the envelope 1 gene sequences of the
51 isolates of hepatitis C virus and to diagnostic methods and vaccines
which employ these reagents. [portfolio: Infectious Diseases--Vaccines]
Isolation of A New Murine Helicobacter Bacteria, Tentatively Classified
as A Helicobacter Hepaticus
Ward, J.M., Fox, J.G., Collins, M.J., Gorelick, P.L., Benveniste,
R.E., Tully, J.G., Gonda, M.A. (NCI)
Filed 24 Jun 94
Serial No. 08/266,414
Licensing Contact: Girish Barua (301/496-7735 ext 263)
An isolated bacterium of the genus Helicobacter, characterized by
the 16S ribosomal RNA encoding nucleotide sequence is described. An
isolated nucleic acid comprising the nucleotide sequence is also
defined. Such a nucleic acid can be used for diagnosis of infection
with H. hepaticus. A nucleic acid of the present invention in a vector
suitable for expression of the nucleic acid is provided. The vector can
be in a host suitable for expressing the nucleic acid. A purified
antigen specific for H. hepaticus and a method of making an animal
model for chronic Helicobacter infection is also described. [portfolio:
Infectious Diseases--Miscellaneous]
Cloning, Expression, and Diagnosis of Human Cytochrome P450 2C19: The
Principal Determinant of S-Mephenytoin Metabolism
Goldstein, J.A., Romkes-Sparks, M., DeMorais, S. (NIEHS)
Filed 6 May 94
Serial No. 08/238,821 (CIP of 08/201,118, CIP of 07/864,962)
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
Two novel cytochrome P450 enzymes have been isolated and
characterized that appear be the principal human determinant of S-
mephenytoin metabolism. This invention has particular application to
the development of more effective anticonvulsant drugs. Mephenytoin is
used for the control of grand mal, focal, Jacksonian, and psychomotor
epileptic seizures that are refractory to other types of anti-
convulsant drugs. In most individuals, mephenytoin is metabolized by 4/
-hydroxylation of S-mephenytoin. This is accomplished by a cytochrome
P450 enzyme in liver cells; however, some subpopulations of individuals
have defects in this P450 enzyme, resulting in reduced levels of S-
mephenytoin 4/ -hydroxylase activity and severe side effects. The DNA
sequence that encodes enzymes from the cytochrome P450 2C subfamily of
enzymes has been isolated and cloned. Polymorphisms of these enzymes,
designated 2C18 and 2C19, appear to be the principal reason that
certain individuals cannot effectively metabolize S-mephenytoin and,
thus, have adverse side effects with this drug. This invention provides
purified cytochrome P450 2C19 peptides and purified cytochrome P450
2C18 polypeptides, as well as the CDNA encoding these polypeptides. The
invention, among other things, also provides methods for screening for
a drug that is metabolized by S-mephenytoin 4/ -hydroxylase activity,
for determining the metabolites activated by a xenobiotic or
carcinogenic compound, and for diagnosing patients with a deficiency in
S-mephenytoin 4/ -hydroxylase activity. [portfolio: Internal Medicine--
Miscellaneous]
Rotavirus Strain And Related Composition
Glass, R.I., Gentsch, J.R., Das, B.K., Bhan, M.K. (CDC)
Filed 15 Apr 94
Serial No. 08/231,041
Licensing Contact: Girish Barua (301/496-7735 ext 263)
Rotavirus is the leading cause of severe diarrheal disease in
infants in both developed and developing countries, and development of
a vaccine for this disease is therefore a global priority. The
availability of both cloned rotavirus genes and protein sequences of
important rotavirus antigens should permit yet additional approaches to
vaccine development.
This invention covers an isolated rotavirus of strain G9P11 and an
isolated nucleic acid encoding the rotavirus and a purified antigen
specific for rotavirus. An isolated nucleic acid that selectively
hybridizes under high stringency conditions with the nucleic acid
encoding the virus is provided. A purified antibody which selectively
binds the virus of strain G9P11 is covered. The G9P11 rotavirus in a
pharmaceutical carrier for administration in an immunization protocol
is disclosed. Also provided are an isolated rotavirus of strain G9P11,
wherein the G9 gene and P11 gene are substituted. [portfolio:
Infectious Diseases--Diagnostics, viral; Infectious Diseases--Vaccines,
viral]
Hepatitis C Virus Core Peptide for Stimulation Of Cytotoxic T
Lymphocytes
Berzofsky, J.A., Feinstone, S.M., Shirai, M. (NCI)
Filed 8 Apr 94
Serial No. 08/224,973
Licensing Contact: Girish Barua (301/496-7735 ext 263)
The invention covers a series of peptide fragments of hepatitis C
virus core protein and their use as activators of cytotoxic T
lymphocytes. The peptides can be used as vaccines or components of
vaccines to prevent hepatitis C. Besides the peptide
[[Page 24869]] fragments, pharmaceutical compositions and methods of
immunization and diagnostics are also claimed. [portfolio: Infectious
Diseases--Therapeutics, anti-virals]
Superactive Vasoactive Intestinal Peptide Antagonist
Gozes, I., Brenneman, D.E., Fridkin, M., Moody, T.W. (NICHD)
Filed 7 Feb 94
Serial No. 08/194,591
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
A potent antagonist of the vasoactive intestinal polypeptide (VIP)
has been developed that may be useful in inhibiting the growth of
certain kinds of lung cancers, among others. VIP is a widely
distributed peptide hormone and neurotransmitter that mediates a
variety of physiologic responses including gastrointestinal secretion;
relaxation of gastrointestinal, vascular, and respiratory smooth
muscle; pituitary hormone secretion; and penile erection. Receptors for
VIP also have been detected in cells derived from small cell lung
carcinoma and three other major types of lung cancer, and VIP has been
shown to promote the growth of these types of lung cancers.
Traditionally, lung cancer is treated with chemo- and/or radiation
therapy, but survival rates for these types of therapies are quite low.
Researchers have now developed a number of short polypeptide sequences
that are able to bind to VIP receptors in various types of cells but do
not display biologic activity. Thus, these polypeptides are potent
inhibitors of VIP activity and may be effective chemotherapeutic agents
in the treatment of certain VIP-sensitive lung cancers. These
polypeptides, which are designed to discriminate between the various
VIP receptors in the body, also may be useful for delineating the
physiologic function of VIP in the CNS and other tissues. [portfolio:
Internal Medicine--Miscellaneous]
IgE-Binding Epitopes of A Major Heat-Stable Crustacean Allergen Derived
From Shrimp
Metcalfe, D.D., Martin, B.M., Rao, P.V.S. (NIAID)
Filed 10 Nov 93
Serial No. 08/149,809
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
Epitopes of a major heat-stable shrimp allergen, which may be
valuable for desensitizing individuals who are allergic to shrimp and
other crustacea, have been developed. Crustacea are among the foods
most frequently associated with immunoglobulin E (IgE)-mediated type I
hypersensitive reactions in individuals with food allergies.
Previously, there has been no method for effectively desensitizing
individuals to crustacea-related allergic reactions. This problem has
been overcome by isolating the IgE allergenic epitopes of the SA-I and
SA-II heat-stable shrimp antigens. These epitopes--or their peptide
derivatives--could potentially be given to patients in order to
desensitize them to the antigens. The use of antigenic epitopes for
desensitization is preferable to using the entire antigen because it
minimizes the possibility of a severe adverse reaction. Because this
IgE-binding antigen is highly conserved among crustacea, potential
application includes diagnosis and treatment of a wide range of
crustacea-induced allergies with only these two allergenic epitopes.
[portfolio: Internal Medicine--Miscellaneous]
Nitric Oxide-Releasing Compounds for the Sensitization Of Hypoxic
Cells in Radiation Therapy
Mitchell, J.B., Krishna, M.C., Wink, D., Liebman, J.E., Russo, A. (NCI)
Filed 8 Oct 93
Serial No. 08/133,574
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
A novel method has been developed for sensitizing oxygen-poor, or
hypoxic, tumor cells, which will increase the effectiveness of
radiation treatment. It has long been known that ionizing radiation is
more effective in killing cancer cells if the cells are in an oxygen-
rich environment; however, the farther tumor cells are away from the
blood supply, the more hypoxic they are and the more resistant they are
to radiation therapy. Current methods for delivering oxygen to hypoxic
cells have limitations because they are toxic to normal tissue, require
oxygen for their activity, or they have too short a half-life. This
development overcomes such problems by employing a nitrous oxide (NO)-
containing compound that spontaneously releases NO under physiologic
conditions without requiring oxygen. This compound--which has a
relatively long half-life and is nontoxic to normals cells--has the
dual advantages of being able to sensitize hypoxic tumor cells to
ionizing radiation while protecting normal cells from the effects of
radiation. [portfolio: Internal Medicine--Therapeutics, cardiology]
Transmission-Blocking Vaccine Against Malaria
Kaslow, C.K., Isaacs, S., Moss, B. (NIAID)
Filed 23 Aug 93
Serial No. 08/110,457 (CON of 07/908,765, CON of 07/658,845)
Licensing Contact: Robert Benson (301/496-7056 ext 267)
A transmission-blocking vaccine developed against malaria contains
a recombinant virus, which encodes a unique portion of the sexual-stage
surface antigen of Plasmodium falciparum (referred to as Pfs25), or the
Pfs25 protein purified from infected host cells. Mice inoculated with
the recombinant virus developed antibodies capable of blocking
transmission of the virus. None of the mAbs known to block transmission
recognize the reduced Pfs25 antigen. This vaccine, which induces high,
long-lasting titers at low cost, can be useful for controlling malaria.
[portfolio: Infectious Diseases--Vaccines, parasite]
Rat Thyrotropin Receptor Gene, and Its Uses
Kohn, L.D., Akamizu, T., Ikuyama, S., Saji, M., Kosugi, S., Ban, T.
(NIDDK)
Filed 29 Nov 93
Serial No. 08/064,058
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
The rat thyrotropin receptor gene has been cloned, which will make
it significantly easier to study this important biologic receptor and
to develop therapies for thyroid gland disorders. Thyrotropin, or
thyroid stimulating hormone (TSH), is a pituitary hormone that
regulates the development and activity of the thyroid gland. Abnormal
binding of thyrotropin to its specific thyroid cell receptor may be the
cause of variety of syndromes such as hypothyroidism; however, the in
situ structure of the thyrotropin receptor remains unclear because a
number of proteins appear to bind to it. Pure sources of this receptor
are unavailable because of the extraordinarily small numbers of
receptors in thyroid cells. Although thyrotropin receptor genes
previously have been cloned for two species (dog and human), a more
desirable starting point for elucidating the structure and function of
the thyrotropin receptor would be to study it in a more utilizable
animal model, such as the rat. The gene product of the cloned FRTL-5
rat thyroid cell receptor can be used in assays to look for ligands
that bind to the receptor. Truncated forms of the protein also may be
used for studying the structure and function of various domains of the
receptor. Ultimately, this invention is useful for developing
treatments for disorders arising from dysfunctions of this receptor.
[portfolio: Internal Medicine--Miscellaneous]
[[Page 24870]]
Nucleotide-Deduced Amino Acid Sequence, Isolation, and Purification of
Heat Shock Chlamydial Proteins
Morrison, R.B., Caldwell, H.D. (NIAID)
Filed 25 Feb 92
Serial No. 07/841,323 (DIV of 07/679,302, DIV of USPN 5,071,962)
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
The chlamydial heat shock protein (HSP60) is an immunodominant
genus common antigen which has been implicated in immunopathologic
delayed type hypersensitivity reactions during chlamydial infections.
The HypB gene which encodes the chlamydial HSP60 has been cloned and
characterized. High levels of HSP60 expression have been obtained in
prokaryotic vectors and methods have been developed for the
purification of the chlamydial HSP60 protein. Availability of large
quantities of purified recombinant chlamydial HSP60 offers novel
approaches to preventing, treating, and diagnosing chlamydial
infections of humans. [portfolio: Infectious Diseases--Diagnostics,
bacterial]
Methods and Compositions for Diagnosing Cat Scratch Disease and
Bacillary Angiomatosis
Regnery, R.L., Anderson, B.E. (CDC)
Serial No. 07/822,539
Patent Issued 21 Mar 95
U.S. Patent No. 5,399,485
Licensing Contact: Carol Lavrich (301/496-7735 ext 287)
A previously unidentified pathogenic species of the rickettsia-like
Bartonella, named B. henselae, sp. nov., has been identified and
characterized. (Note: The genus designation Bartonella is now applied
to and replaces the Rochalimaea genus designation.) This new organism
causes two clinically related diseases: Bacillary angiomatosis and cat
scratch disease. Currently, diagnosis of Bartonella diseases is limited
to detection of the etiologic agent associated with ``trench fever'',
referred to as B. quintata. Novel diagnostic tests using
immunofluorescence assays or ELISAs can detect the newly discovered
pathogen in sera from infected individuals and distinguish it from B.
quintata, thus offering improved differential diagnosis for disease
syndromes such as ``trench fever'', bacillary angiomatosis, cat scratch
disease, and bacillary peliosis hepatitis. [portfolio: Infectious
Diseases--Diagnostics, bacterial]
Effect of Cadmium on Human Ovarian Cancer Cells With Cisplatin
Resistance
Bo Lee, K., Parker, R.J., Reed, E. (NCI)
Filed 3 Mar 95
Serial No. 08/398,460
Licensing Contact: Raphe Kantor (301/496-7735 ext 247)
The present invention describes Cadmium (Cd) as a potential
anticarcinogenic compound useful in treating ovarian cancer. The
inventors observed strong tumor suppressive effects when applied to
human ovarian cancer cell lines in vitro. The effects of Cd on cellular
sensitivity, cellular drug accumulation and efflux, and Cd-DNA adduct
formation and repair were examined. Cadmium is shown to have a
subcellular profile that is similar, though not identical, to
cisplatin, suggesting the possibility of future use of CD as an anti-
cancer agent. [portfolio: Cancer--Therapeutics, conventional
chemotherapy, antimetabolites]
Trapping of Aflatoxins and Phytoestrogens
Umrigar, P.P., Kuan, S.S. (FDA)
Filed 6 Jan 93
Serial No. 08/001,573
Licensing Contact: John Fahner-Vihtelic (301/496-7735 ext 285)
A unique process has been invented for removing aflatoxins and
phytoestrogens from food samples that is a significant improvement over
currently available methods. Aflatoxins are carcinogenic substances
that are found in foods such as grains and peanuts and, thus, are a
danger to public health. Phytoestrogens--structurally related to
aflatoxins--are found in soy products and also are of concern to public
health. Therefore, it is important to be able to measure concentrations
of these compounds in foodstuffs. The current method for determining
aflatoxin or phytoestrogen concentrations in foods requires passing a
food sample through an affinity column containing immobilized
antibodies specific for aflatoxins or a solid phase extraction (SPE)
column for phytoestrogens. The bound aflatoxins or phytoestrogens are
eluted from the affinity column and then measured using high
performance liquid chromatography; however, such affinity columns and
SPE columns are extremely expensive, have limited shelf life, and
cannot be reused. These limitations have been overcome by developing
columns packed with new derivatives of a copolymer of cyclodextrin and
epichlorohydrin. These new copolymers, which have proven particularly
useful in trapping aflatoxins and phyto-estrogens, are extremely stable
and are not damaged when aflatoxins or phytoestrogens are removed by a
suitable solvent. Thus, these materials are re-usable. [portfolio:
Devices/Instrumentation--Miscellaneous]
Dated: May 1, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-11422 Filed 5-9-95; 8:45 am]
BILLING CODE 4140-01-P
