[Federal Register Volume 66, Number 23 (Friday, February 2, 2001)]
[Notices]
[Pages 8808-8809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2809]


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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.

RASS1: A Novel Tumor Suppressor Gene Activated by Ras To Promote 
Apoptosis

Geoffrey J. Clark and Michelle Vos (NCI)
DHHS Reference No. E-237-00/0
Licensing Contact: Richard Rodriguez; 301/496-7056 ext. 287; e-mail: 
[email protected]

    Mutant ras oncogenes are frequently associated with human cancers, 
and activated Ras proteins have been found to mediate a broad array of 
biological effects. These effects are generated due to the ability of 
activated Ras to interact with numerous effector proteins, and the 
disclosed invention directly relates to such a novel effector, namely, 
RASS1. While many of Ras' activities are linked to cell growth and cell 
transformation, this putative tumor suppressor gene and its protein 
product seem to be effectors which mediate apoptotic cell death. The 
patent application contains composition of matter claims as well as 
method claims all of which are directed to the detection, diagnosis and 
treatment of cancer as well as providing data for cancer susceptibility 
or prognosis following diagnosis of a cancer. The application also 
provides claims directed toward gene therapy applications for this 
technology.

Antiprogestins With Partial Agonist Activity

Simons et al. (NIDDK)
DHHS Reference No. E-015-00/0 filed 24 March 2000
Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; e-mail: 
[email protected]


[[Page 8809]]


    Antisteroids block the action of steroid hormones. For this reason, 
antisteroids have been attractive clinical tools to suppress the 
effects of endogenous steroids both in a variety of disorders, 
including breast and uterine cancers, and in birth control. Much 
research has been devoted to finding pure antisteriods that would 
prevent any action of endogenous steriods. Unfortunately, antisteriod 
treatments are associated with many side effects, most of which result 
from the repression of the wide variety of normally expressed genes. 
For this reason, attention has recently shifted to selective receptor 
modulators (SRMs), which are antisteroids with partial agonist activity 
with some responsive genes. Those SRMs that cause the repression of the 
fewest genes, other than the genes that are targeted for inhibition, 
would be expected to have the fewest side effects and the widest 
clinical applications. Almost all existing antiprogestins suffer from 
two disadvantages. First, they block virtually all actions of 
progesterone receptors and display very little partial agonist 
activity. Second, most progestins are also potent antiglucocorticoids 
and suppress genes regulated by glucocorticoids, thus expanding the 
scope of undesirable side effects. Presently, the only antiprogestin 
reported to have significant amounts of partial agonist activity, and 
thus any prospect of being a selective progesterone receptor modulator 
(SPRM), is RTI 3021-020.
    The NIH now announces that two derivatives of the potent 
glucocorticoid dexamethasone (Dex) show partial agonist activity under 
a variety of conditions and represent novel leads to new SPRMs. These 
derivatives are Dex-21-mesylate (Dex-Mes) and Dex-oxetanone (Dex-Ox). 
In direct comparisons with RTI 3021-020, Dex-Mes and Dex-Ox have 
consistently displayed more partial agonist activity even under 
conditions where RTI 3021-020 was inactive. Therefore, Dex-Mes, Dex-Ox, 
or other Dex derivatives, may be useful as partial progesterone 
agonists under a wider variety of conditions both in the laboratory and 
in the clinical setting, such as the treatment of endometriosis and 
leiomyomas of the uterus, to name a few. Furthermore, Dex-Mes and Dex-
Ox also possess partial agonist activity with glucocorticoid receptors, 
thus reducing the side effects resulting from the repression of 
glucocorticoid-regulated genes.

    Dated: January 24, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 01-2809 Filed 2-1-01; 8:45 am]
BILLING CODE 4140-01-P