[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72450-72452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-6802]


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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.

Modified Recombinant Anti-Tumor RNase

Dianne L. Newton, David F. Nellis, Susanna M. Rybak (NCI)
U.S. Provisional Application filed 30 Sep 2005 (HHS Reference No. E-
265-2005/0-US-01)
Licensing Contact: Jesse Kindra; 301/435-5559; [email protected].

    Members of the ribonuclease A (RNase A) superfamily such as 
Onconase[supreg] or rapLR1 have potential for clinical use either 
alone, combined with drugs, or as the toxic component of targeted 
therapy. In targeted therapies,

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the RNase is conjugated to a targeting moiety, such as an antibody. 
Typically the RNase is chemically modified before it can be linked to 
another molecule. These methods usually require a large excess of 
unmodified RNase. The current invention provides genetically modified 
thiol-containing RNase molecules that can be used in much lower amounts 
to generate chemical conjugates. Additionally, the inserted thiol group 
provides the advantage of a site-directed and specific attachment of 
the RNase to targeting moieties. The invention also provides 
methodologies for generating cysteine-modified RNase conjugates and 
methods of using such conjugates.

Methods and Compositions for the Inhibition of SARS-CoV Replication 
Propagation and Transmission

Sharon M. Wahl and Gang Peng (NIDCR)
U.S. Provisional Application No. 60/713,724 filed 06 Sep 2005 (HHS 
Reference No. E-253-2005/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial development is a method of 
inhibiting SARS-CoV replication, propagation and transmission using 2-
cyano-3,12-dioxooleana-1,9-dien-28-oic (CDDO). Severe acute respiratory 
syndrome (SARS) is an infectious atypical pneumonia that has recently 
been recognized in patients in 32 countries and regions. The atypical 
pneumonia with unknown etiology was initially observed in Guangdong 
Province, China. This observation was followed by reports from Hong 
Kong, Vietnam, Singapore, Canada and Beijing of severe febrile 
respiratory illness that spread to household members and health care 
workers. This disease was later designated ``severe acute respiratory 
syndrome (SARS)'' by the World Health Organization (WHO). Until May 19, 
2003, a cumulative total of 7,864 SARS cases were reported to WHO from 
29 countries. A total of 643 deaths (case-fatality proportion: 8.2%) 
were reported.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Methods of Treating and Preventing Renal Cancer Using a Dimethane 
Sulfonate Compound

Drs. Susan Mertins, David Covell and Geoffrey Patton (STB, NCI-
Fredrick), Melinda Hollingshead (BTB, DTB, NCI-Fredrick), B. Rao 
Vishnuvajjala (PRB, DTP, NCI-Bethesda), and Susan Bates (CTB, CCR, NCI-
Bethesda).
HHS Reference No. E-249-2005/0-PCT-01
Licensing Contact: George G. Pipia; 301/435-5560; [email protected].

    Currently only a few small molecule inhibitors are effective in 
patients with renal cell carcinoma. Approximately 30,000 patients per 
year are diagnosed with this disease but many of them are untreatable 
because of intrinsic drug resistance, and efficient drug transport and 
detoxification mechanisms. This invention described and claimed in the 
patent application describes a series of dimethane sulfonate compounds 
based on NSC 281612 that are suitable for the treatment of renal 
cancer. Compositions comprising a pharmaceutically-acceptable carrier 
and a compound, or a salt suitable for use in the treatment or 
prevention of renal cancer are also described. The anti-tumor activity 
of NSC 281612 has been established in vivo against human renal tumor 
xenografts in mice. Suitable dosing and administration schedules for 
treatment of renal tumors have also been determined in this study.

Noncovalent HIV Env-CD4 Complexes for Generation of Broadly 
Neutralizing Antibodies

Jinhai Wang and Michael Norcross (FDA)
U.S. Provisional Application No. 60/711,985 filed 25 Aug 2005 (HHS 
Reference No. E-173-2005/0-US-01)
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    HIV vaccine technology based on HIV envelope protein (Env) have 
been less successful than anticipated to date. One possible reason for 
this is the potential conformational masking of neutralizing epitopes. 
The current technology combines HIV Env and cell surface polypeptides 
CD4 in non-covalent complexes to expose epitopes not present on the 
uncomplexed Env molecules. These complexes can thus be used to elicit 
neutralizing antibodies when used as vaccines, immunogenic compositions 
or immunotherapies. The CD4 inducing epitopes found in regions of the 
virus that are most conserved across clades are unmasked, thus making 
this technology potentially effective against HIV viruses from several 
clades. Additionally, cell surface polypeptide CD4 is in its native 
conformation and masked by Env, therefore it is unlikely to induce 
autoantibodies.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors. If you are interested in additional information on this 
collaborative opportunity, please contact Ms. Beatrice A. Droke at 
[email protected].

Synthesis of Indenoisoquinoliniums and Methods of Use

Yves Pommier et al. (NCI).
PCT Application No. PCT/US2005/08491 filed 15 Mar 2005 (HHS Reference 
No. E-058-2005/0-PCT-02).
Licensing Contact: George G. Pipia; 301/435-5560; [email protected].

    The technology relates to compounds and methods for treating 
cancer. Specifically, novel Topoisomerase I (Top I) inhibitors are 
disclosed. Top I is a DNA-modifying enzyme whose activity is required 
for viability of rapidly dividing cells such as cancer cells. Top I is 
a target of the potent anti-cancer drug Camptothecin, which inhibits 
Top I activity. However, camptothecin-based cancer therapies can 
produce side effects caused by toxicity of camptothecin.
    The disclosed compounds are substituted indenoisoquinolinium 
compounds that inhibit Top I activity. The compounds exhibit anti-
cancer activity and have chemical properties that may facilitate the 
development of novel anti-cancer therapies with reduced toxicity.

Confocal Fiber-Optic Laser Method for Intraocular Lens Power 
Measurement

Ilko K. Ilev (FDA).
U.S. Provisional Application No. 60/668,239 filed 03 Mar 2005 (HHS 
Reference No. E-039-2005/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected].

    Available for licensing and commercial development is a novel 
apertureless fiber-optic laser confocal design. Intraocular lens (IOL) 
dioptic power is a fundamental parameter whose precise measurement is 
of critical importance for characterizing and evaluating the 
effectiveness and safety of IOL's. The present invention relates to a 
simple, accurate, objective, quick and relatively inexpensive method 
for IOL power measurement. The principle of operation of this method is 
based on an apertureless fiber-optic laser confocal design. The key 
element in this design is a single-mode optical fiber coupler that 
simultaneously performs several essential functions. First, it provides 
effective launching and delivery of the input laser emission. Second, 
the fiber tip serves as a point light source used

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for formation of a collimated Gaussian laser beam profile for IOL 
testing. Third, the tip serves as a highly sensitive point receiver of 
the back reflectance laser emission. Fourth, the fiber coupler provides 
delivery of the spatially separated back reflected laser emission to a 
detector system. The combination of these unique features of the 
confocal fiber-optic laser method provides high accuracy (exceeding 1 
[mu]m) in spatially locating the IOL focal point and measuring the IOL 
power. A unique feature of this method is that it allows for 
measurement of a wide range of both positive and negative powers 
including high-magnification IOL's with power greater than 20 diopters. The simple and high-sensitive IOL power testing 
method will provide the CDRH/FDA and the scientific community with an 
independent source of measurement data and information for evaluating 
the effectiveness and safety of novel IOL products.

Minimally Immunogenic Variants of SDR-Grafted Humanized Antibody CC49 
and Their Use

Syed Kashmiri (NCI), Jeffrey Schlom (NCI), and Eduardo Padlan (NIDDK)
U.S. Provisional Application No. 60/493,903 filed 29 Aug 2003 (HHS 
Reference No. E-323-2003/0-US-01) and PCT Application No. PCT/US04/
28004 filed 27 Aug 2004 (HHS Reference No. E-323-2003/0-PCT-02).
Licensing Contact: Michelle Booden; 301/451-7337; [email protected].

    Tumor Associated Glycoprotein 72 (TAG)-72 is an oncofetal antigen 
expressed on a majority of human carcinomas, including colorectal, 
gastric, pancreatic, breast, lung, and ovarian. The murine monoclonal 
antibody (mAb) CC49 specifically recognizes TAG-72 and has a higher 
affinity for TAG-72 than its predecessor, B72.3.
    The present invention relates to humanized monoclonal antibodies 
that have high binding affinity for the tumor-associated glycoprotein 
(TAG)-72 with minimal immunogenicity. This anti-TAG-72 antibody binds 
to the same epitope as the CC49 murine variant developed at the 
National Cancer Institute. The variants of CC49 described in this 
patent application have been shown to have a decreased immune response, 
with comparable binding affinity, than the parent murine antibodies.
    These variants have potential benefits for use in the detection 
and/or treatment of a range of human carcinomas. Certain fields of use 
may not be available. Please contact OTT for information regarding the 
availability of specific fields of use. This variant was published in 
Kashmiri et al., ``Minimizing Immunogenicity of the SDR-grafted 
Humanized Antibody CC49 by Genetic Manipulation of the Framework 
Residues,'' Molecular Immunology, 40 (2003), 337-349.

Restenosis/Atherosclerosis Diagnosis, Prophylaxis, and Therapy

Toren Finkel et al. (NHLBI)
U.S. Patent No. 6,183,752 issued 06 Feb 2001 (HHS Reference No. E-258-
1994/0-US-01)
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected].

    This technology relates to the compositions and methods for the 
diagnosis, prevention, and therapy of restenosis and atherosclerosis. 
It involves the use of an agent for decreasing viral load, preferably a 
vaccine, against cytomegalovirus (CMV) and p53, including a method for 
providing the therapy and administering the agent. This invention thus 
relates to stimulating an immune response, preferably a cellular immune 
response, directed against CMV and p53 to inhibit or prevent 
restenosis, atherosclerosis, and smooth muscle proliferation. 
Therefore, the technology offers methods for inducing cell death with 
the purpose of inhibiting smooth muscle proliferation as a means of 
preventing or treating restenosis and atherosclerosis.

    Dated: November 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E5-6802 Filed 12-2-05; 8:45 am]
BILLING CODE 4140-01-P