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###### Department of Health and Human Services

###### National Institutes of Health

# 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.                    

## Quantitative Measurement of Syndesmophytes in Ankylosing Spondylitis Using Computed Tomography (CT)

Description of Technology: Syndesmophyte (abnormal bone) growth in the spine is a hallmark of Ankylosing Spondylitis, a type of inflammatory arthritis. Syndesmophyte growth is currently monitored using semi-quantitative scoring of radiographs, but radiographs consider only a small part of the vertebra, and the method is subject to reader error. Because syndesmophytes grow slowly, radiographs also lack sensitivity. The invention provides a method to measure syndesmophytes using data from computed tomography scans of the lumbar spine. It provides computer algorithm that fully quantitates syndesmophyte volumes in three-dimension space. This method allows precise and accurate measurement of the presence and rate of growth of syndesmophytes over time, which for the first time will permit testing of whether any treatments can slow the progression of this type of spinal arthritis.

Potential Commercial Applications:
      - The method would be useful for clinical trials of drugs against Syndesmophyte growth.
      - Because of the improved precision, achieving statistical significance in assessing the efficacy of a drug would require smaller samples.

Competitive Advantages:
      - The present method is more automated than existing methods.
      - The method is more precise and sensitive than existing methods, thus providing more reliable statistical analysis and improved planning in treatment regimen.

Development Stage: In vivo data available (human).

                    Inventors: Sovira Tan (NIAMS),                     *et al.*

Publication: Tan S, Yao J, Ward MM, Yao L, Summers RM. Computer aided evaluation of ankylosing spondylitis using high-resolution CT. IEEE Trans Med Imaging 2008 Sep;27(9):1252-1267. [PMID 18779065].

Intellectual Property: HHS Reference No. E-167-2011/0—Software. Patent protection is not being pursued for this technology.

                    Licensing Contact: Michael Shmilovich,                     *Esq.;*                     301-435-5019;                     *shmilovm@mail.nih.gov.*

                    Collaborative Research Opportunity: The National Institute of Arthritis and Musculoskeletal and Skin Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Brian W. Bailey, Ph.D. at                     *bbailey@mail.nih.gov.*      ( print page 51377)    

## An Automated Method for Precise Measurement of Vertebral Body Height and Intervertebral Disk Height Using Computed Tomography

Description of Technology: Vertebral fractures due to osteoporosis result in loss of vertebral height. Degenerative disk disease in the spine results in loss of disk height. Currently, radiography and magnetic resonance imaging are used to assess vertebral and disk height, and measurements are done manually. The present invention offers improved method to measure vertebral and disk heights. The invention provides computer algorithm that substantially automates the task, and uses computed tomography. The advantage of computed tomography over radiography is that of 3D imaging over 2D imaging. Computed tomography's advantage over MRI is better image resolution. The combination of automation and superior imaging capability makes the method substantially more precise than previous ones. This allows better detection of changes in vertebral height and disk height over time, and thus aids in the planning of appropriate medical treatment in cases associated with the loss of vertebral or disk heights, such as in osteoporosis for example.

Potential Commercial Applications:
      - The method would be useful for clinical trials of drugs for osteoporosis.
      - Because of the improved precision, achieving statistical significance in assessing the efficacy of a drug would require smaller samples.

Competitive Advantages:
      - The present method is semi-automated.
      - The method is more precise and sensitive than existing methods, thus providing more reliable statistical analysis and improved planning in treatment regimen.

Development Stage: In vivo data available (human).

                    Inventors: Sovira Tan (NIAMS),                     *et al.*

Intellectual Property: HHS Reference No. E-166-2011/0—Software. Patent protection is not being pursued for this technology.

                    Licensing Contact: Michael Shmilovich,                     *Esq.;*                     301-435-5019;                     *shmilovm@mail.nih.gov.*

                    Collaborative Research Opportunity: The National Institute of Arthritis and Musculoskeletal and Skin Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Brian W. Bailey, Ph.D. at                     *bbailey@mail.nih.gov.*

## Monoclonal Antibodies Against Poliovirus

Description of Technology: Early work by Hammond et al. showed gamma globulin to be effective for the prevention of poliomyelitis. Therefore, passive immunotherapy could be another way to treat chronic excretors. Even though prior attempts to use intravenous immunoglobulin (IVIG) and breast milk were unsuccessful, there is reason to think that higher doses of antipoliovirus antibodies could result in complete clearance of poliovirus from chronically infected individuals. Six poliovirus-neutralizing MAbs were recovered from a combinatorial Fab phage display library constructed from bone marrow-derived lymphocytes of immunized chimpanzees. The six MAbs neutralized vaccine strains and virulent strains of poliovirus. Five MAbs were serotype specific, while one MAb cross-neutralized serotypes 1 and 2. Both serotype 2-specific antibodies recognized antigenic site 1. No escape mutants to serotype 3-specific MAbs could be generated. The administration of a serotype 1-specific MAb to transgenic mice susceptible to poliovirus at a dose of 5 μg/mouse completely protected them from paralysis after challenge with a lethal dose of wild-type poliovirus. Moreover, MAb injection 6 or 12 h after virus infection provided significant protection. This application claims the antibodies described above and methods for their use.

Potential Commercial Applications:
      - Prophylaxis/therapeutic for poliovirus.
      - Post-exposure emergency prophylaxis of poliovirus.

Competitive Advantages:
      - No humanization required.
      - Highly potent neutralizing antibodies.
      - Biological materials available.

Development Stage:
      - Pre-clinical.
      - In vitro data available.
      - In vivo data available (animal).

Inventors: Zhaochun Chen, Robert H. Purcell, Konstantin Chumakov (NIAID).

                    Publication: Chen Z,                     *et al*. Chimpanzee-human monoclonal antibodies for treatment of chronic poliovirus excretors and emergency postexposure prophylaxis. J Virol. 2011 May;85(9):4354-4362. [PMID: 21345966].                

Intellectual Property: HHS Reference No. E-076-2011/0—U.S. Provisional Application No. 61/443,915 filed 17 Feb 2011.

                    Licensing Contact: Peter Soukas, J.D.; 301-435-4646;                     *soukasp@mail.nih.gov*.                

## Methods of Treating Giardiasis Using FDA-Approved Compounds

                    Description of Technology: This technology includes a group of at least twenty-nine, diverse, commercially available compounds that are newly identified for activity against                     *Giardia lamblia*                     parasites. At least six of the candidate compounds, Bortezomib, Decitabine, Hydroxocobalamin, Amlexanox, Idarubicin, and Auranofin have preexisting FDA approval for human use for other (non-Giardia) conditions. Another three compounds, Fumagillin, Nitarsone and Carbadox have preexisting approval for veterinary use for non-Giardia conditions. Additional active compounds identified include: Acivicin, Riboflavin butyrate, BTO-1, GW9662, Dinitroph-dfgp, Deserpidine, Tetramethylthiuram disulsulfide, Disulfiram, Mitoxantrone, Ecteinascidin 743, 17-allyaminogeldanamycin, Carboquone and Nocodazole. The anti-Giardial activity of these compounds presents a cost saving opportunity for the rapid development of new, better tolerated treatments for the most prevalent human intestinal parasite infection in the United States and the world.                

Potential Commercial Applications:
      - Treatment of Giardia in humans.
      - Treatment of Giardia in animals—dogs and cats.

Competitive Advantages: These compounds have currently been approved for human and veterinary uses of other indications which provides an opportunity to greatly reduce risk and pre-market investments both in terms of time and costs associated with development and regulatory approval for new Giardia applications including the drug resistant Giardiasis.

Development Stage:
      - Early-stage.
      - Pre-clinical.
      - In vitro data available.

Inventors:
      - Wei Zheng, Catherine Chen, Juan J. Marugan, Noel T. Southall, Christopher P. Austin (NHGRI).
      - Osnat Hertzberg, Luidmila Kulakova, Andrey Galkin (Institute for Bioscience & Biotechnology Research, University of Maryland).

Publication: Chen CZ, et al. High-throughput Giardia lamblia viability assay using bioluminescent ATP content measurements. Antimicrob Agents Chemother. 2011 Feb;55(2):667-675. [PMID 21078930].

Intellectual Property: HHS Reference No. E-211-2010/1—U.S. Provisional Application No. 61/411,509 filed 09 Nov 2010.

                    Licensing Contact: Tedd Fenn; 301-435-5031;                     *Tedd.Fenn@nih.gov.*      ( print page 51378)    

                    Collaborative Research Opportunity: The NHGRI is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Novel Compounds for Treatment of Giardiasis. For collaboration opportunities, please contact Claire Driscoll, NHGRI, at                     *cdriscol@mail.nih.gov.*

Dated: August 12, 2011.

Richard U. Rodriguez,

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

[FR Doc. 2011-21155 Filed 8-17-11; 8:45 am]

BILLING CODE 4140-01-P