[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Notices]
[Pages 39462-39464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19180]


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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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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 no 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 and issued patents listed below may be obtained by 
contacting Susan Rucker, J.D., at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301/496-7056 ext 245; fax: 
301/402-0220). A signed Confidential Disclosure Agreement will be 
required

[[Page 39463]]

to receive copies of the patent applications.

Novel Epidermal Growth Factor Receptor (ErbB-3) and Antibodies

M Kraus, SA Aaronson (NCI)
Serial No. 07/444,406 filed 04 Dec 89, which issued as U.S.
Patent No. 5,183,884 on 02 Feb 93; and
Serial No. 07/978,895 filed 10 Nov 92, which issued as U.S.
Patent No. 5,480,968 on 02 Jan 96; and
Serial No. 08/473,119 filed 07 Jun 95; and
Serial No. 08/475,352 filed 07 Jun 95

    ErbB-3 is a member of the type I family of growth factor receptors. 
ErbB-3 is a 148 kd transmembrane polypeptide which has between 64-67% 
homology to contiguous regions within the tyrosine kinase domains of 
the EGFR and erbB-2 proteins, respectively. ERbB-3 has been mapped to 
human chromosome 12 ql 11-13 and has been shown to be expressed as a 
6.2 kb transcript in a variety of normal tissues of epithelial origin. 
Markedly elevated erbB-3 MRNA levels have been demonstrated in certain 
human mammary tumor cell lines. These findings suggest that increased 
erbB-3 expression may play a role in oncogenesis.
    U.S. Patent 5,183,884 includes claims to the cDNA encoding erbB-3, 
vectors containing the cDNA and cells transformed with the vector 
containing the cDNA encoding erbB-3. The DNA can be used in diagnostic 
applications or for production of the protein.
    U.S. Patent 5,480,968 includes claims to the erbB-3 protein and 
antibodies to erbB-3. Such antibodies include both monoclonal and 
polyclonal antibodies. The antibodies may be labeled allowing for 
detection of erbB-3, or conjugated with a cytotoxic agent for use as a 
therapeutic.
    The divisional applications, 08/473,119 and 08/475,352, include 
claims to DNA and antibody based diagnostic methods, drug screening 
assays, therapeutic applications utilizing antibody conjugates or 
ligands which block the binding of an activating ligand to erbB-3; 
activating or blocking ligands which bind to erbB-3. (portfolio: 
Cancer--Diagnostics, in vitor, MAb based; Cancer--Diagnostics, in vivo, 
MAb; Cancer--Therapeutics, immunoconjugates, MAb; Cancer--Research 
Reagents)

Peptide Antagonist of Keratinocyte Growth Factor Activity

D Bottaro, JS Rubin, SA Aaronson (NCI)`
Filed 04 May 93
Serial No. 08/059,030

    A novel peptide antagonist of the keratinocyte growth factor (KGF) 
activity has been isolated that may prove to be an effective treatment 
for diseases in which activation of the KGF receptor plays a role. 
Growth factors are important mediators of intercellular communication. 
These molecules are generally released by one cell type and influence 
proliferation of other cell types. Interest in growth factors has been 
heightened by evidence of their involvement in neoplasia. In addition, 
a number of oncogenes are homologs of genes encoding growth factor 
receptors, and their receptor-mediated signal transduction pathways 
provide insights into mechanisms of both normal and malignant cell 
growth. The fibroblast growth factor family affects the growth of a 
wide variety of cells including connective tissue cells. KGF is a 
member of this family, but is unique in that its activity is restricted 
to cells of epithelial origin. Since a vast majority of human 
malignancies are derived from epithelial tissues, identification of 
compounds that modulate the effect of KGF may be important in the 
treatment of carcinomas as well as other conditions in which ligand-
dependent proliferation, mediated by the KGF receptor, contributes to 
the pathologic disorder. These novel peptides effectively inhibit 
binding between KGF and its epithelial cell receptor and, thus, are 
useful in treating carcinomas and other conditions involving epithelial 
cell proliferation. (portfolio: Cancer--Therapeutics, biological 
response modifiers, growth factors)

Expression Cloning of a Human Phosphatase

    SA Aaronson, DP Bottaro, T Ishibashi, T Miki (NCI)
    U.S. Serial No. 07/988,273 filed 14 Dec 92; WO 94/13796, PCT/US93/
12019
    U.S. Patent No. 5,512,434 issued 30 Apr 96

    The identification of genes has traditionally been accomplished 
through the use of nucleic acid hybridization. In general, highly 
conserved sequences or DNA structures which are associated with a 
particular function or gene family are used in hybridization techniques 
in order to discover other related genes and associated polypeptide 
products. This is accomplished by construction of nucleic acid probes 
corresponding to those conserved DNA sequences of interest. The present 
invention involves ``expression cloning,'' and provides an alternative 
method of isolating genes of interest by using the expression of the 
polypeptide corresponding to that gene as a means of screening clones 
containing the gene. The invention describes methods of detecting 
clones containing the functional polypeptide either directly, or 
through immunological methods. The invention further describes a new 
dual specificity protein tyrosine phosphatase, called VHR, discovered 
using this method. This phosphatase is structurally unrelated to other 
commonly known enzymes with similar function and provides support for 
the invention's utility. The invention also describes methods for 
treatment of VHR related disease. This invention is ideally suited for 
use in the isolation of previously unknown genes with similar functions 
of interest. The invention allows isolation of fewer false positive 
clones because DNA sequences with areas of high structural homology but 
dissimilar function, will not be identified. The invention, in 
contrast, favors the isolation of clones which are structurally 
disparate, yet functionally equivalent. (portfolio: Gene Based 
Therapies--Diagnostics; Gene-Based Therapies--Research Tools and 
Reagents; Devices/Instrumentation--Diagnostics, physical medicine; 
Devices/Instrumentation--Research Tools, methods; Devices/
Instrumentation--Biologicals and Chemicals)

The Many Roles of Adrenomedulin in Human Pathology and Physiology

FF Cuttitta (NCI)
DHHS Reference No. E-206-95/0 filed 18 Aug 95 and
DHHS Reference No. E-206-95/1 filed 30 Aug 95

    Adrenomedullin (AM) is a -amidated 52-amino acid peptide 
that shows slight similarity to calcitonin gene-related peptide (CGRP). 
The effects of AM and its fragments in the cardiovascular system have 
been widely studied. Endothelial cells secrete the peptide that acts on 
specific receptors present in the vascular smooth muscle cells and 
other contractile cells. Some diuretic functions have been also 
described. In the respiratory system, two major roles have been 
described to date: relaxation of the vascular bed and bronchodilation.
    The present invention provides methods for the prevention and 
treatment of cancers, in particular, lung, colon, ovarian, and breast 
cancers by inhibiting the growth of the cancerous cells with an 
effective amount of anti-AM monoclonal antibody. This invention 
provides methods for diagnosing or monitoring diseases by measuring the 
levels of AM in a sample. Examples of diseases include, diabetes, renal 
diseases, such as severe uremia; bone diseases, such as neoplastic

[[Page 39464]]

disease; and skin diseases. The present invention also provides a 
method of preventing or treating type II diabetes using the anti-AM 
monoclonal antibody. AM peptides and antibodies can also be utilized 
for diagnosis and treatment of preeclampsia and to promote fetal 
growth.
    The present invention provides a method of regulating activity in 
areas of the central nervous system by administering to a subject an 
effective amount of AM peptides or antibodies for the regulation of 
neurotransmission or neuron growth. i.e. Alzheimer's disease. 
Administering antibodies to AM can inhibit the degranulation of mast 
cells and provide a method of lessening or inhibiting the allergic 
response due to the degranulation of mast cells. AM peptides have also 
been found to inhibit bacterial or fungal growth and facilitate the 
healing of chaffed skin, skin lesions, wound repair, and surgical 
incisions. AM peptides promote organ and bone development. (portfolio: 
Cancer--Therapeutics; Central Nervous System--Therapeutics; Infectious 
Diseases--Therapeutics; Internal Medicine--Therapeutics)

    Dated: July 17, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-19180 Filed 7-26-96; 8:45 am]
BILLING CODE 4140-01-M