[Federal Register Volume 67, Number 217 (Friday, November 8, 2002)]
[Notices]
[Pages 68146-68147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28538]


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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 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.

Regulation of INS (3456) P4 Signalling by a Reversible Kinase/
Phosphatase and Methods and Compositions Related Thereto

Dr. Stephen Shears (NIEHS)
DHHS Reference No. E-105-2002/0 filed Mar 18, 2002
Licensing Contact: Marlene Shinn; 301/435-4426; [email protected].

    Signaling entities are frequently controlled by quite delicate 
shifts in the dynamic balance of regulatory signals with competing 
impacts. Ion channels provide particularly impressive

[[Page 68147]]

examples of the degree of signal amplification that can result; 
switching the conductance state of a single channel can influence the 
transmembrane movement of millions of ions per second. Both stimulatory 
(Ca \2\t and CaMKII) and inhibitory 
(Ins(3,4,5,6)P4 signals converge on the family of so-called 
``Ca \2\t-activated'' Cl- channels. Thus 
receptor-dependent changes in Ins(3,4,5,6)P4 levels is a 
topic of general biological significance, in that it impacts upon 
regulation of salt and fluid secretion from epithelial cells, cell 
volume homeostasis, and electrical excitability in neurons and smooth 
muscle. Unfortunately, understanding of the cellular control on 
Ins(3,4,5,6)P4-signaling has been rudimentary, because the 
pathway of Ins(3,4,5,6)P4 synthesis has not previously been 
characterized.
    The NIH announces new treatment methods for asthma, bronchitis and 
cystic fibrosis. The treatments consist of either increasing or 
decreasing the activity of inositol 1,3,4,5,6 pentakisphosphate 1-
phosphatase in a patient, thereby controlling 
Ins(3,4,5,6)P4-signaling which in turn affects the choride 
channels and mucus secretion produced. This modulation of inositol 
1,3,4,5,6 pentakisphosphate 1-phosphatase is accomplished with the help 
of an inositol phosphate kinase, which can also act as an inositol 
pentakisphosphate 1-phosphatase.

Mutated Constitutively Active Nuclear Orphan Receptor

    Masahiko Negishi, Akiko Ueda, Lars C. Pedersen, Satoru Kakizaki, 
Tatsuya Sueyoshi (NIEHS)
DHHS Reference No. E-034-2002/0 filed Feb. 19, 2002
Licensing Contact: Marlene Shinn; 301/435-4426; [email protected].

    The constitutively active nuclear orphan receptor (CAR) activates 
transcription of genes encoding various drug-metabolizing enzymes such 
as cytochromes P450 in response to drug exposures. Induction of these 
enzymes confers on organisms a higher metabolic capability to defend 
themselves against xenochemical toxicity and/or carcinogenicity. Direct 
drug responses, however, have not been demonstrated with CAR in a cell-
mediated transfectin assay, due to its in vitro constitutive activity.
    The NIH announces the creation of an altered CAR molecule, with 
decreased constitutive activity in vitro using site-directed 
mutagenesis to the receptor. This alteration allows the CAR molecule to 
be directly activated by drugs and can be used for in vitro drug 
screening that will make the screenings more efficient and cost 
effective.

Bone-Forming Composition, Methods for Making and Methods of Use

Mahesh H. Mankani, Sergei Kuznetsov, Pamela G. Robey (NIDCR)
DHHS Reference No. E-263-2001/0 filed Jan. 25, 2002
Licensing Contact: Marlene Shinn; 301/435-4426; [email protected].

    Transplantation of bone marrow stromal cells (BMSCs) offers a 
method for repairing and/or closing large bone defects. Although most 
bone defects occur as a result of trauma, bone loss can also arise from 
congenital disorders, neoplasms, and/or infections. To make BMSC 
transplantation most useful as a method for engineering new bone, it 
would be helpful to optimize the growth rate, extent, and strength of 
newly formed bone. Current methods of transplantation produce bone that 
is nonuniform in size, shape and form, making it difficult to compare 
bone samples directly.
    The NIH announces a new method of forming bone tissue based on 
using a combination of bone marrow stromal cells and hydroxyapatite/
tricalcium phosphate particles. The newly created bone has desired 
dimensions, which are similar, consistent, and/or identical to the 
shapes of the preformed compositions. When the composition is made with 
human BMSCs derived from pathological tissue, and transplanted into 
immunodeficient mice, the new bone reproduces features of the original 
disease, allowing for the testing of agents that inhibit, stimulate, or 
modify bone formation.

Methods of Making, Using and Pharmaceutical Formulations Comprising 7-
Alpha,11-Beta-Dimethyl-17-Beta-Hydroxyestra-4,14-Dien-3-One and 17 
Esters Thereof and 7-Alpha,11-Beta-Dimethyl-17-Beta-Hydroxyestra-4-en-
3-One 17-Undecanoate

Drs. Richard Blye and H.K. Kim (NICHD)
DHHS Reference No. E-069-2000/3 filed Mar. 29, 2002 (PCT-CIP Patent 
Application)
Licensing Contact: Marlene Shinn; 301/435-4426; [email protected].

    The NIH announces a new technology that relates to compounds that 
possess potent androgenic activity. These compounds offer a potential 
therapeutic benefit in the treatment of hypogonadism, regardless of 
cause, as an adjuvant in hormone replacement therapy for both men and 
women and for androgen stimulation of anabolism in a broad spectrum of 
disease entities involving debilitation.
    These compounds exhibit both oral and parenteral androgenic 
activity. Oral activity appears greater than that of 
methyltestosterone. Parenteral activity as an aqueous suspension is 
substantially longer than that produced by testosterone enanthate or 
testosterone cypionate. Since these compounds lack a 17-alkyl moiety, 
they are expected to show less hepatotoxicity upon oral administration. 
Claims in this patent application are drawn to the new androgenic 
compounds themselves, their method of preparation, pharmaceutical 
formulations containing the new androgens and their utility and use in 
a wide spectrum of therapeutic applications.

    Dated: November 4, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-28538 Filed 11-7-02; 8:45 am]
BILLING CODE 4140-01-P