[Federal Register Volume 73, Number 36 (Friday, February 22, 2008)]
[Notices]
[Pages 9818-9819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3274]



[[Page 9818]]

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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, HHS.

ACTION: Notice.

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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.

Papilloma Pseudovirus for Detection and Therapy of Tumors

    Description of Technology: There is extensive literature on the use 
of viral vectors, particularly those based on the adenovirus and AAV, 
to increase the potency of anti-tumor gene therapy. However, these 
approaches have had limited success because of limited anti-tumor 
effects and unacceptable toxicity. This invention describes the use of 
papillomavirus pseudoviruses (PsV) as a gene transfer technology and a 
tumor diagnostic method. Preliminary studies showed that PsV bind to 
cells that were transplanted with human ovarian tumor (Shin-3) while 
normal tissues were not affected. PsV does not infect several other 
normal intact tissues but continues to selectively infect additional 
cell types that are damaged. Additionally, the inventors have 
constructed oligoT PsV vectors that can be engineered to express 
certain cytotoxic genes to induce tumor regression and simultaneously 
increase human papilloma virus' immunogenicity. This technology could 
be an effective anti-tumor therapy because it has shown increased 
infection of compromised cells with an inability to infect normal cells 
thereby reducing potential toxicity to patients. In addition to a 
potential anti-cancer therapeutic, this technology could also be used 
as a diagnostic tool in the detection of tumor masses. Detection can be 
achieved through the use of fluorescent dye coupled particles of PsV 
that have preferential binding to tumor tissues and not normal tissues.
    Applications:
    Method to treat and selectively target cancer with limited 
toxicity.
    Method to accurately diagnose cancer.
    Anti-tumor therapeutic vaccines.
    Anti-tumor cytoxic gene therapy constructs.
    Market:
    An estimated 1,444,920 new cancer cases in 2007.
    600,000 cancer deaths in the U.S. in 2006.
    It is estimated that market for cancer drugs would double to $50 
billion a year in 2010 from $25 billion in 2006.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Jeffrey Roberts, John T. Schiller, Douglas R. Lowy 
(NCI).
    Publications:
    1. CB Buck et al. Generation of HPV pseudovirions using 
transfection and their use in neutralization assays. Methods Mol Med. 
2005; 119:445-462.
    2. CB Buck et al. Efficient intracellular assembly of 
papillomaviral vectors. J Virol. 2004 Jan; 78(2):751-757.
    Patent Status: U.S. Provisional Application No. 60/928,495 filed 08 
May 2007 (HHS Reference No. E-186-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].

Collagen-Induced Platelet Aggregation Inhibitor From Mosquito Salivary 
Glands

    Description of Technology: Exposed collagen in injured blood 
vessels provides a substrate for platelets to adhere and aggregate 
initiating the first step in thrombosis, the formation of blood clots 
inside a blood vessel. Despite the essential role of platelets in 
vascular injury, excessive platelet aggregation may also result in 
thrombotic diseases such as stroke and heart attack.
    Available for licensing is a collagen binding protein, named 
aegyptin, which selectively inhibits collagen-platelet aggregation, but 
not platelet aggregation induced by other agonists. Collagen initiates 
recruitment of circulating platelets and triggers platelet activation. 
Collagen also plays a critical role in angiogenesis. Aegyptin blocks 
the interaction of collagen with its major ligands, von Willebrand 
factor, glycoprotein VI (GPVI), and integrin a2[beta]1. These three 
ligands are of particular importance because von Willebrand factor 
plays a critical role in tethering platelets to collagen, GPVI is the 
major signaling platelet receptor, and integrin a2[beta]1 mediates 
platelet adhesion and contributes to activation. Since these ligands 
play a critical role in the early stages of thrombus formation, 
aegyptin represents a potentially highly effective therapeutic that can 
prevent and treat patients with thrombotic disease. Alternatively, 
aegyptin is potentially useful in conditions where collagen plays a 
critical role in angiogenesis or in conditions where excessive 
deposition of collagen plays a pathological role (e.g. pancreatic 
carcinoma).
    Applications:
    Adjuvant to ``Clot busting'' therapeutics.
    Method to prevent and/or treat cardiovascular/thrombotic disease.
    Method to treat patients undergoing invasive cardiovascular 
procedures (e.g. angioplasty).
    Model to study collagen-dependent platelet aggregation or collagen-
mediated angiogenesis.
    Advantages:
    Highly effective therapeutics can negatively modulate thrombosis in 
its early stages by preventing collagen interaction with three major 
ligands involved in thrombus/clot formation.
    Aegyptin's potential use as a prototype for drug delivery as an 
oral therapeutic, which can reduce the need for invasive surgeries that 
dilate blood vessels such as stents or catheters.
    Market:
    Thrombolytic/antithrombotic therapies are worth billions of 
dollars, common therapeutics include heparin, warfarin, and plasminogen 
activators.
    Anticancer and antiangiogenic therapies.
    Cardiac disease is the number one cause of death in the U.S.
    Pancreatic cancer is one of the most lethal cancers, where only 23% 
of patients will survive after one year of diagnosis, and 4% survive 
after five years of diagnosis.
    An estimated 37,170 Americans will be newly diagnosed with 
pancreatic cancer in 2007.
    An estimated 33,370 deaths from pancreatic cancer in the U.S. in 
2007.
    Pancreatic cancer is the fourth leading cause of cancer death in 
the U.S.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Eric Calvo et al. (NIAID).

[[Page 9819]]

    Related Publications:
    1. A manuscript directly related to this technology will be 
available as soon as it is accepted for publication.
    2. E Calvo. Collagen-platelet aggregation inhibitor from mosquito 
salivary glands. Biacore T100 seminar series, November 2006, St. Louis, 
Missouri.
    3. S Yoshida and H Watanabe. Robust salivary gland-specific 
transgene expression in Anopheles stephensi mosquito. Insect Mol Biol. 
2006 Aug; 15(4):403-410.
    4. D Sun et al. Expression of functional recombinant mosquito 
salivary apyrase: a potential therapeutic platelet aggregation 
inhibitor. Platelets. 2006 May; 17(3):178-184.
    Patent Status: U.S. Provisional Application No. 60/198,629 filed 09 
Jul 2007 (HHS Reference No. E-172-2007/0-US-01); U.S. Provisional 
Application No. 60/982,241 filed 24 Oct 2007 (HHS Reference No. E-172-
2007/1-US-01)
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; [email protected]
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Laboratory of Malaria and Vector 
Research, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize the platelet aggregation inhibitor Aegyptin. Please 
contact Dr. Jose Ribeiro, Head, Vector Biology Section, at 301-496-9389 
or [email protected] for more information.

Manganese Superoxide Dimutase VAL16ALA Polymorphism Predicts Resistance 
to Doxorubicin Cancer Therapy

    Description of Technology: Cancer is the second leading cause of 
death in the United States and it is estimated that there will be 
approximately 600,000 deaths caused by cancer in 2006. Major drawbacks 
of the existing cancer therapies are the interindividual differences in 
the response and the cytotoxic side-effects that are associated with 
them. Thus, there is a need to develop new therapeutic approaches to 
optimize treatment and increase patient survival.
    This technology describes the identification of a manganese 
superoxide dismutase (MnSOD) polymorphism as a novel biomarker for the 
prognosis of doxorubicin therapeutic response in breast cancer 
patients, wherein a Val16Ala polymorphism of MnSOD is indicative of 
patient survival. More specifically, patients undergoing doxorubicin 
combination therapy with Val/Val, Val/Ala, and Ala/Ala genotypes had 
95.2%, 79%, and 45.5% survival rates, respectively, in a case study of 
70 unselected breast cancer patients. Carriers of the Ala/Ala genotype 
had a highly significantly poorer breast cancer-specific survival in a 
multivariate Cox regression analysis than carriers of the Val/Val 
genotype. This technology can be developed into an assay to screen for 
breast cancer patients who will be responsive to doxorubicin treatment. 
Further, as the MnSOD polymorphism is common in the population (15% to 
20% of patients have the Ala/Ala genotype), it is a common risk factor 
for doxorubicin therapy. This technology can potentially be utilized as 
a screening tool applicable for all cancer types treated with 
doxorubicin.
    Applications:
    A novel genetic marker that can predict breast cancer patient 
survival with doxorubicin treatment.
    A screening test based on MnSOD Val16Ala genotype that predicts 
patient response to doxorubicin cancer therapy, wherein treatment can 
be subsequently individualized according to patient MnSOD genotype.
    Development Status: Future studies include determining the 
mechanism in which the polymorphism modulates doxorubicin toxicity.
    Inventors: Stefan Ambs and Brenda Boersma (NCI).
    Patent Status: U.S. Provisional Application No. 60/799,788 filed 11 
May 2006 (HHS Reference No. E-137-2006/0-US-01); PCT Application No. 
PCT/US2007/068588 filed 09 May 2007 (HHS Reference No. E-137-2006/0-
PCT-02).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Human 
Carcinogenesis, Center for Cancer Research, National Cancer Institute, 
National Institutes of Health, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize MnSOD genotyping assays to assess a 
patient's response to doxorubicin combination therapy. Please contact 
John D. Hewes, PhD, at 301-435-3121 or [email protected] for more 
information.

    Dated: February 15, 2008.
David Sadowski,
Deputy Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E8-3274 Filed 2-21-08; 8:45 am]
BILLING CODE 4140-01-P