01-19641. Government-Owned Inventions; Availability for Licensing

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 contacting Matthew Kiser at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone] ext. 224; fax: [phone]; e-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Anticancer Effects of Novel Vitamin D Receptor Antagonists

Julianna Barsony (NIDDK); DHHS Reference No. E-213-01/0 filed 20 Jun 2001

The present invention relates to cancer therapeutics. Specifically, this invention relates to novel selective vitamin D receptor modulators (SEDM), also known as vitamin D receptor antagonists. Methods of treatment resulting in inhibition of cell growth, inducement of cell differentiation, inhibition of breast cancer growth, and inhibition of parathyroid hormone secretion in mice are disclosed.

Vitamin D does not have significant biological activity. Rather, it must be metabolized within the body to its hormonally active form, calcitriol. Calcitriol acts through the vitamin D receptor (VDR) to regulate important functions, such as calcium homeostasis, cell proliferation and differentiation, and immune functions. Many cancers contain VDR and, therefore respond to calcitriol. In such cancers, low concentrations of calcitriol stimulate growth and high concentrations inhibit growth. High doses of calcitriol and calcitriol analogues, however, cause hypercalcemia, limiting the use of this hormone for cancer treatment.

The present invention relates to derivatives of calcitriol that have been synthesized in a manner similar to the principles developed to create estrogen receptor modulators (SERM). These vitamin D receptor modulators bind well to VDR, inhibit their ability to stimulate cancer cell growth and increase their ability to induce cell differentiation. In mice, SEDM inhibited human breast cancer growth without causing hypercalcemia. The technology disclosed herein may also be used for the prevention of breast cancer, treatment and/or prevention of other types of conditions or diseases, such as, but not limited to, prostate, colorectal, and lung cancers, leukemia, primary or metastatic melanoma, glyoma, and parathyroid diseases.

Method of Treating Cutaneous T-Cell Lymphoma by Administering a Histone Deacetylase Inhibitor

Susan Bates, Tito A. Fojo, Richard Piekarz (NCI), DHHS Reference No. E-123-00/0 filed 18 Aug 2000

The subject invention provides a method of treating cutaneous T-cell lymphoma and peripheral T cell lymphoma in a mammal. The method comprises administering to the mammal an effective amount of a histone deacetylase inhibitor. Preferably, the histone deacetylase inhibitor is a depsipeptide, in particular the depsipeptide known as NSC 630176. The method can further comprise (i) administering a steroid, a P-glycoprotein multiple drug resistance (MDR) antagonist, an antibody to a T-cell receptor and/or a retinoid, or any IL2 receptor targeted therapy, (ii) the use of chemotherapy, and/or (iii) the use of photochemotherapy.

Dated: July 30, 2001.

Jack Spiegel,

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