E6-14353. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency 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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

ABCB1 Genotyping To Predict Paclitaxel Toxicity

Description of Technology: Paclitaxel has been a frontline chemotherapeutic drug used for the treatment of various cancers including metastatic breast cancer and ovarian cancer. Its use has successfully prolonged patient survival. A major drawback of paclitaxel is the cytotoxic side-effects that are associated with it such as myologenic and neurogenic toxicities. The degree of such toxicities varies with individual patients. Predicting the extent of such toxicities following paclitaxel treatment will immensely help in defining optimal treatment schedules for each individual patient. Concurrently, it will significantly improve patient quality of life.

This technology describes the identification of three genetic markers in the ABCB1 (MDR-1, P-glycoprotein) gene that can be used to predict the degree of neutropenia and peripheral neuropathy that an individual will experience following paclitaxel treatment. These markers were identified using DNA from blood samples of cancer patients undergoing paclitaxel treatment. This technology can be developed into a routine blood test to identify patient subsets that are more susceptible to paclitaxel treatment associated neutropenia and neuropathy.

Applications:

1. Three novel genetic markers that can predict extent of paclitaxel associated toxicities.

2. A screening test based on ABCB1 genotype profiling using patient blood samples that predicts paclitaxel associated neutropenia and peripheral neuropathy.

Market: The diagnostic market is worth about $3 billion by 2007 and estimated to grow further.

Development Status:

1. The technology is a pilot study currently in the pre-clinical stage of development.

2. A prospective ABCB1 genotype directed clinical trial is foreseen in the near future.

Inventors: William D. Figg (NCI), Alex Sparreboom (NCI), Tristan M. Sissung (NCI), Stephan Mielke (NCI), et al.

Publication: T. M Sissung et al. Association of ABCB1 genotypes with paclitaxel-mediated neutropenia and peripheral neuropathy, To be submitted to Clinical Pharmacology and Therapy.

Patent Status: U.S. Provisional Application No. 60/807,453 filed 14 Jul 2006 (HHS Reference No. E-237-2006/0-US-01).

Licensing Status: Available for non-exclusive or exclusive licensing.

Licensing Contact: David Lambertson, PhD; 301/435-4632; [e-mail].

Collaborative Research Opportunity: The NCI Medical Oncology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize ABCB1 genotyping to predict paclitaxel toxicity. Please contact Betty Tong, PhD at 301-496-0477, [e-mail] for more information.

Use of Grape Skin Extracts as Anti-Cancer Agents

Description of Technology: The invention describes anti-tumor effects of extracts from grape skins. Grape skin extract and derivatives may therefore be useful as preventive or therapeutic agents against tumor development.

Literature indicates that grape and red wine consumption may be inversely associated with prostate cancer risk. Moreover, to date there are no known grape skin extract-associated toxicities described. The current invention discloses that grape skin extract, or purified fractions thereof, inhibited metastatic growth in human prostate transformed cell lines. Specifically, grape skin extract induced cellular apoptosis via inhibition of the phosphatidylinositol 3-kinase (PI3-K)/Akt survival pathway.

Historically, anti-tumor effects of grapes were mainly attributed to resveratrol, a phytoalexin present in grapes, nuts and wild berries. However, resveratrol's mechanism of anti-tumor action is distinct from that of grape skin extract, in that it arrests cell cycle division without significant induction of apoptosis.

The current invention also provides for methods of treating patients with prostate cancer or persons at risk for developing prostate cancer with compositions that include grape skin extract or active anti-tumor fractions thereof.

Development Status: Pre-clinical stage.

Inventors: Tamaro Hudson and Jeffrey E. Green (NCI).

Patent Status: U.S. Provisional Application No. 60/789,181 filed 03 April 2006 (HHS Reference No. E-179-2006/0-US-01).

Licensing Status: Available for non-exclusive or exclusive licensing.

Licensing Contact: David A. Lambertson, PhD; 301-435-4632; [e-mail].

Collaborative Research Opportunity: The NCI's Laboratory of Cell Regulation and Carcinogenesis is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Patrick Twomey, PhD at 301-496-0477 or [e-mail] for more information.

Dated: August 23, 2006.

Steven M. Ferguson,

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