[Federal Register Volume 65, Number 160 (Thursday, August 17, 2000)]
[Notices]
[Pages 50206-50207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20922]


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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, Public Health Service, DHHS.

ACTION: Notice.

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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 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 contacting Dennis Penn, at 
the Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; 
telephone: 301/496-7056 ext. 211; fax: 301/402-0220; e-mail: 
[email protected]. A signed Confidential Disclosure Agreement will be 
required to receive copies of the patent applications.

Preparation and Use of Androgenic Compounds

    Richard P. Blye and Hyun K. Kim (NICHD) DHHS Reference Nos. E-069-
00/0 filed 31 Mar 2000 and E-069-00/1 filed 04 Apr 2000.
    The technology describes the finding of the orally active 
androgenic compound, 7, 11-dimethyl-19-
nortestosterone 17-bucyclate (Also known as CDB-4386A). This 17-
bucyclate androgen compound is orally bioavailable and possesses 
greater potency than Methyltestosterone, the only oral androgen 
commercially available in this country. Too, this compound may be 
injected as an aqueous suspension, whereas other injectable androgens 
require an oil diluent. Androgens find use in the treatment of male 
hypogonadism regardless of the cause. Consequently they are used for 
the treatment of hypogonadotropic hypogonandism, as the androgenic 
component of male hormonal contraceptives and for androgen 
supplementation in hormone replacement therapy (HRT) in both men and 
women.

Process for Preparing 17-Alpha-Acetoxy-11-Beta-[4-(N,N-
Dimethylamino)phenyl]-21-Methoxy-19-Norpregna-4,9-Diene-3,20-Dione, 
Intermediates Useful in the Process, and Processes for Preparing 
Such Intermediates

    Hyun K. Kim (NICHD), and Pemmaraju Rao, James Cessac, and Anne 
Marie Simmons of the Southwest Foundation for Biomedical Research DHHS 
Reference No. E-013-00/0 filed 29 Dec 1999.
    This invention relates to a process for preparing 17-alpha-acetoxy-
11-beta-[4-(N,N-dimethylamino)phenyl]-21-methoxy-19-norpregna-4,9-
diene-3,20-dione. This method substantially increases the yield over 
existing methods and will substantially reduce the cost of production 
of this compound. Other advantages include: (1) Use of smaller 
quantities of solvent and reagent; (2) use of intermediates, reagents, 
or byproducts which are relatively safe to handle and dispose of, no 
use of chromatography; (3) a purification procedure easier to practice 
on large scale from kilograms to multi-kilograms, including no use of 
chromatography if possible; and (4) in some cases, recycling the by-
products was successfully achieved.

Novel Anti-thrombin Peptide From Mosquito Salivary Gland

    Jesus G. Valenzuela, Jose M.C. Ribeiro, and Ivo Francischetti 
(NIAID) DHHS Reference No. E-143-99/0 filed 29 Jun 1999.
    Currently, treatment and prophylaxis of thrombotic diseases involve 
therapeutic agents which act in one of two different ways. The first 
type inhibits a-thrombin activity or a-thrombin formation, thus 
preventing clot formation. The second category accelerates thrombolysis 
and dissolves the blood clot, thereby removing it from the blood vessel 
and unblocking the flow of blood. Heparin is an example of the first 
class and is widely used; however, heparin is less effective in 
treating patients with an anti-thrombin III deficiency. Hirudin is an 
example of the second class of anti-thrombotic drugs.
    This invention relates to an anti-thrombin (Anophelin) isolated 
from the salivary glands of the mosquito Anopheles albimanus. The 
purified peptide inhibits thrombin induced platelet aggregation, 
thrombin esterolytic activity, and thrombin cleavage of fibrinogen. 
This peptide has no homologies to proteins of known function in 
GenBank, and is a novel, specific, and tight binding inhibitor of 
-thrombin.

Ichthyosiform Skin Diseases

    Peter M. Steinert, Nemes Zoltan and Lyuben Marckov (NIAMS) DHHS 
Reference No. E-149-99/0 filed 23 Jun 1999.
    Many inherited autosomal recessive ichthyoses (ARI) are caused by 
improper or incomplete lipid barrier function in the skin due to 
genetic errors of either protein or lipid synthesis. It is previously 
known that the mutations in the transglutaminase 1 gene resulting in 
inactive enzyme is the cause of one ARI disease termed lamellar 
ichthyosis. This relates to the discovery that a principal function of 
the enzyme is to attach ceramide lipids for complete protein/lipid 
barrier function in the skin. This invention also describes how to: (1) 
Make large quantities of this enzyme that can be stored in a stable 
form which can be readied for use at short notice; (2) a simple way to 
make synthetic ceramide lipid analogs that function the same way as 
normal skin ceramides; and (3) make synthetic lipid vesicles that can 
carry, in a stable fashion, both the enzyme and synthetic ceramide so 
that it might be applied to affected ARI skin in order to provide 
ameliorative therapy.

[[Page 50207]]

High Sensitivity Phage Display Protein Detection Method

    Carl R. Merril (NIMH) DHHS Reference No. E-185-98/0 filed 14 Apr 
1999.
    This new technology extends the range of protein detection 
appreciably under the absolute limit of 0.01ng for the Silver stain 
method. In an average protein molecule this amounts to 20 million 
molecules. The average cellular concentration of protein is 5000 
molecules, so that an amplification system is needed to detect protein 
on that level. In this method, phage that display specific ligands or 
antibodies provide such an amplification system and therefore allow for 
detection. In addition, a particular phage expressing a known binding 
protein may be used to identify a specific protein and aid in the 
purification of that specific protein. The identification ability has 
both diagnostic and therapeutic potential.
    The key novel feature of this technology in the market place would 
be its high sensitivity and the numerous benefits associated with it. 
It opens up whole new areas of analysis, such as on the cellular level, 
allowing for looking at protein variations within a single cell. 
Theoretically, as little as one protein molecule could be detectable.
    The potential market for this invention would be in several 
distinct areas: Research--incorporation into kits to perform complete 
assays; Purification--aiding in the manufacturing process; Diagnostic--
detection of variations of a specific protein within a cell; 
Therapeutic--identification of specific drug targets through the 
ability to bind to receptor sites.

    Dated: August 3, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-20922 Filed 8-16-00; 8:45 am]
BILLING CODE 4140-01-P