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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

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: rodrigur@od.nih.gov

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: shinnm@od.nih.gov

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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.

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Dated: January 24, 2001.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 01-2809 Filed 2-1-01; 8:45 am]

BILLING CODE 4140-01-P