[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Notices]
[Pages 59454-59455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29894]


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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 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.

Production of Infectious Respiratory Syncytial Virus From Cloned 
Nucleotide Sequences

PL Collins (NIAID)
Serial No. 08/720,132 filed 27 Sep 96 (claiming priority date of 27 Sep 
95)
Licensing Contact: Robert Benson, 301/496-7056 ext 267

    This invention is a method of producing infectious RSV from cDNA 
encoding the RSV relicative intermediate RNA and cDNA encoding the N, 
P, L and M2(ORF1) proteins of RSV, which are used to transfect a cell. 
Claimed are cells or cell lysates comprising these cDNA molecules, 
recombinant RSV and methods of producing the recombinant RSV. The 
invention is particularly useful for producing mutant RSV as attenuated 
RSV vaccine candidates. Mutations in the RSV genome known to have an 
attenuated phenotype can be placed together in the RSV genome using 
known techniques and made into infections in the RSV genome using known 
techniques and made into infectious RSV using the invention. Vaccine 
candidates can be stably stored as cDNA molecules and modified as 
needed, for example to accommodate genetic drift in circulating RSV. 
The invention is described in P.N.A.S. 92, 11563-11567, 1995. This 
patent application has been foreign filed. (portfolio: Infectious 
Diseases-Vaccines, viral, non-AIDS; Infectious Diseases-Research 
Materials)

Glycoprotein Hormone Superagonists

MW Szkudlinski, BD Weintraub, M Grossman (NIDDK)
OTT Reference No. E-015-96/0 filed 08 May 96
Licensing Contact: J. Peter Kim, 301/496-7056 ext 264

    The glycoprotein hormones, which include thyroid-stimulating 
hormone, follicle-stimulating hormone, luteinizing hormone, and 
chorionic gonadotropin, are involved in the development and regulation 
of the ovary, testes, and thyroid. These hormones are heterodimers, 
each consisting of a non-covalently linked alpha and beta subunit. 
While the amino acid sequence of the beta subunit is hormone-specific, 
that of the alpha subunit is identical in all hormones within the same 
species. Embodied in the current invention are human glycoprotein 
hormones which contain specific amino acid substitutions within the 
alpha as well as beta subunits. These substitutions result in 
glycoprotein hormone analogs, or ``superagonists,'' which exhibit a 
significant increase in in vitro and in vivo bioactivity over the wild-
type hormone. These superagonists, therefore, appear to represent 
potential agents for use in the treatment of a variety of conditions, 
including various forms of male and female infertility and thyroid 
carcinoma. (portfolios: Internal Medicine-Therapeutics, contraceptives; 
Internal Medicine-Other)

Inhibitory and Non-Inhibitory Antigen Binding Polypeptides Against 
Human P450 Enzymes

HV Gelboin, FJ Gonzalez (NCI)
Serial No. 08/559, 808 filed 17 Nov 95
Licensing Contact: Leopold J. Luberecki, Jr., 301/496-7735 ext 223

    This invention concerns monoclonal antibodies (MAbs) specific for 
particular members of the cytochrome P450 family of enzymes. The 
cytochrome P450s are the metabolic interface between xenobiotics and 
their metabolism in human and other species as well as for the 
metabolism of endobiotics. A large array of drugs, mutagens, 
carcinogens, pesticides, environmental chemicals, fatty acids, bile 
acids, and steroids are metabolized by individual forms of cytochrome 
P450. The invention involves the construction, isolation, and 
production of MAbs that specifically bind to human cytochrome P450 3A3, 
3A4, 3A5, and 2E1 and that specifically inhibit the enzyme activity of 
human cytochrome P450 3A3, 3A4, and 3A5, and 2E1 (inhibitory MAbs) and 
MAbs that specifically bind to cytochrome P450 3A3, 3A4, 3A5, and 2E1, 
without inhibiting enzyme activity (non-inhibitory MAbs). Novel 
inhibitory MAbs to human P450 have been in development for some time. 
These MAbs can be used to assess adverse reactions in patients to 
compounds and to identify populations that would exhibit different 
sensitivities to the therapeutic or toxic effects of compounds. 
Cytochrome P450 3A4 and 3A3 are very important members of the P450 
family of enzymes. The human P450 3A4 and 3A3 metabolize a large 
variety of drugs, steroids, and carcinogens. Cytochromes P450 3A3 and 
3A4 are considered the most important P450s for a wide range of high 
molecular weight substrates which include many of the known clinically 
useful drugs, such as tranquilizers, antidepressants, 
immunosuppressants, and anticancer drugs. Cytochrome P450 2E1 is 
important because it metabolizes low molecular weight compounds 
susceptible to environmental hazards and carcinogens. The human P450 
2E1 also metabolizes clinically useful drugs such as the anesthetic 
chlorzoxazone and the analgesic acetaminophen as well as caffeine. 
Issuance of a patent for this invention is currently pending. 
(portfolio: Internal Medicine-Miscellaneous; Cancer-Research Reagents, 
MAb based; Internal Medicine-Diagnostics; Cancer-Diagnostics, in vitro, 
MAb based)

Prevention of Progression in Vascular Disease

GE Striker, LJ Striker, FP Sherman (NIDDK)
Serial No. 08/478,347 filed 07 Jun 95
Licensing Contact: Carol Lavrich, 301/496-7056 ext 287

    This invention relates to efficacious methods and pharmaceutical 
compositions in the treatment of chronic progressive vascular diseases 
(CPVD) characterized by scarring and/or fibrosis to halt and reverse 
the disease process by resolving scar and fibrotic lesions. These 
methods consist of the administration to patients of an effective 
amount of Elmiron. The oral route of administration is preferred, with 
total

[[Page 59455]]

daily dosage of Elmiron ranging from about 50 to 1200 mg per day. This 
method of treatment utilizes a commercially available pharmaceutical 
agent which may be administered by conventional means, while remaining 
non-toxic and efficacious in the treatment of CPVD. (portfolio: 
Internal Medicine--Therapeutics, cardiology)

Circularly Permuted Ligands and Circularly Permuted Fusion Proteins

IH Pastan, RJ Kreitman (NCI)
Serial No. 08/255,224 filed 08 Apr 94
Licensing Contact: Larry Tiffany, 301/496-7056 ext 206

    Circularly permuted proteins are ligands wherein the amino and 
carboxy ends have been joined together and new amino and carboxy ends 
are formed at a different location in the ligand. The modified ligands 
are as fully active as the original. The circularly permuted ligands 
are especially useful when employed as a component in a fusion protein 
of interest. Fusion proteins are polypeptide chains of two or more 
proteins fused together in a single polypeptide chain. A fusion protein 
may act as a potent cell-killing agent or as a linker to bind and 
enhance the interaction between cells or cellular components to which 
the protein binds, depending on the nature of the proteins being fused. 
Therefore, fusion proteins have functional utility as a specific 
targeting moiety to either kill or direct an immune response to cancer 
cells. While some targeting moieties have shown lower specificity and 
affinity for their targets when incorporated into fusion proteins, the 
use of circularly permuted ligands improves the binding affinity of 
certain fusion proteins. This invention provides novel ligands and 
ligand fusion proteins that have a binding specificity and affinity 
comparable to or greater than native ligand fusion proteins. 
(portfolio: Cancer--Therapeutics, immunoconjugates, toxins; Cancer--
Therapeutcs, immunoconjugates, MAb)

    Dated: November 14, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-29894 Filed 11-21-96; 8:45 am]
BILLING CODE 4140-01-M