[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Notices]
[Pages 51627-51628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14353]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 301/496-7057; fax: 301/402-0220. 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.

[[Page 51628]]

    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; 
[email protected].
    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, [email protected] 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; 
[email protected].
    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 [email protected] 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.
 [FR Doc. E6-14353 Filed 8-29-06; 8:45 am]
BILLING CODE 4140-01-P