[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70788-70791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28630]


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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.

FOR FURTHER INFORMATION CONTACT: 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,

[[Page 70789]]

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.

Axon Regeneration After Brain or Spinal Cord Injury

    Description of Technology: The invention is directed to 
modification of a particular sugar by the enzyme arylsulfatase B 
(ARSB), which results in axon regeneration.
    Following traumatic brain or spinal cord injury, glial scars 
prevent regeneration of axons. Chondroitin sulfate proteoglycans 
(CSPGs) are major components of glial scars. CSPGs are made of a 
protein core containing glycosaminoglycan (GAG) sugar side chains, 
which, when sulfated, are responsible for the inhibitory activity of 
glial scars. Specifically, NIH researchers have shown that the 4-
sulfate unit on a certain sugar on GAG is responsible for inhibiting 
axon regrowth and, when the 4-sulfate unit is reduced, axon regrowth is 
observed. Moreover, removal of this 4-sulfate unit by the ARSB enzyme 
promotes axon regrowth.
    As a potential therapy for spinal cord injuries, researchers 
developed a vector expressing ARSB and demonstrated that this vector 
promotes axon regeneration when injected into the spinal cord of a 
mouse.
    Potential Commercial Applications:
     Treatment of brain and spinal cord injury.
     Treatment of other CNS injuries, including stroke.
     Treatment of heart attack.
    Competitive Advantages:
     There are no existing products for treatment of traumatic 
spinal cord injury.
     ARSB is already approved for treatment of 
Mucopolysaccharoidosis VI, a lysosomal storage disease.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Herbert M. Geller and Yasuhiro Katagiri (NHLBI).
    Publication: Wang H, et al. Chondroitin-4-sulfation negatively 
regulates axonal guidance and growth. J Cell Sci. 2008 Sep 15;121(Pt 
18):3083-91. [PMID 18768934].
    Intellectual Property: HHS Reference No. E-214-2012/0--U.S. 
Provisional Application No. 61/705,555 filed 25 Sept 2012.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected].
    Collaborative Research Opportunity: The NHLBI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the use of ARSB 
in axonal regeneration after brain or spinal cord injury using animal 
models. For collaboration opportunities, please contact Denise Crooks, 
Ph.D. at 301-435-0103 or [email protected].

Nitric Oxide-Releasing Polyvinylpyrrolidone-Based Polymers for Wound 
Healing and Related Applications

    Description of Technology: Novel nitric oxide-releasing 
polyvinylpyrrolidone-based polymers, their compositions, and use in 
treating wounds. The disclosed polymers appear to be stable, 
biocompatible and bioabsorbable, while providing for extended nitric 
oxide release at therapeutic levels. The invention also encompasses 
medical devices, such as wound dressings and bandages, which include 
the polymers and are capable of releasing nitric oxide when in use. 
These devices may be used to treat a wound, various infections, and 
dermatological conditions.
    The therapeutic efficacy of nitric oxide has been demonstrated for 
many indications, including wound healing. As wounds are deficient in 
nitric oxide, its application has been shown to have beneficial effects 
on wound healing by promoting angiogenesis and tissue remodeling.
    Potential Commercial Applications: Wound healing, infections, and 
dermatological conditions.
    Competitive Advantages: The claimed nitric oxide-releasing polymers 
are bioabsorbable and release greater amounts of nitric oxide over a 
greater period of time than other NO-releasing polymers.
    Development Stage:
     Early-stage.
     Pre-clinical.
    Inventors: Joseph A. Hrabie and Larry K. Keefer (NCI).
    Intellectual Property: HHS Reference No. E-157-2012/0--US 
Provisional Application No. 61/672,486 filed 17 Jul 2012.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].

Gag-Based DNA Vaccines Against HIV

    Description of Technology: Novel DNA vaccine constructs against HIV 
that express highly conserved elements (CE) within the HIV Gag protein 
and elicit strong, cross-clade cellular and humoral responses. The DNA 
vaccine vectors were engineered to express CEs for protection against 
different clades of HIV and prevention of immunodominance, two issues 
associated with current HIV vaccine candidates.
    In vivo studies of Rhesus macaques vaccinated with variants of 
these constructs expressing seven highly CEs covering >99 of all known 
Gag sequences elicited strong, cellular T-cell and humoral antibody 
immune responses. The Gag-specific antibody responses were high titer 
and cross-clade. Cross-clade protection is important given the sequence 
diversity of HIV as is the absence of immunodominant epitopes that 
generate antibodies which are not protective against HIV.
    Potential Commercial Applications: HIV vaccines.
    Competitive Advantages: Addresses two key hurdles faced by current 
HIV vaccines: sequence diversity of HIV and immunodominance.
    Development Stage:
     Early-stage.
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventors: George N. Pavlakis (NCI), Barbara K. Felber (NCI), James 
Mullins (University of Washington).
    Intellectual Property: HHS Reference No. E-132-2012/0--U.S. 
Provisional Application No. 61/606,265 filed 02 Mar 2012.
    Related Technology: HHS Reference No. E-308-2000/0--Patent family 
filed in the U.S., Canada, Australia, Europe, and Japan.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].

Diagnostic Test and Therapeutic Target for Sjogren's Syndrome

    Description of Technology: Sj[ouml]gren's syndrome is an autoimmune 
disease that attacks salivary glands resulting in chronic dry mouth and 
dry eyes. Currently, there is no single diagnostic test to confirm the 
presence of Sj[ouml]gren's. Physicians presently reach diagnosis after 
conducting a series of blood and functional tests for tear and salivary 
production. Diagnosis is further complicated as Sj[ouml]gren's symptoms 
frequently mimic those of other autoimmune diseases (e.g., lupus, 
rheumatoid arthritis, etc.) and is often overlooked as dryness 
associated with medications being taken by the patient.
    Researchers at NIDCR have identified overexpression of a growth 
factor, bone morphogenetic protein 6 (BMP6), in patients with 
Sj[ouml]gren's. By detecting BMP6 expression and/or activity, this 
invention potentially presents a singular confirmation to diagnose 
those suffering

[[Page 70790]]

and those at risk for developing Sj[ouml]gren's. BMP6 also presents a 
potential therapeutic target for Sj[ouml]gren's, a disease for which 
there is presently no cure.
    Researchers have also discovered unique expression profiles for two 
other genes (XIST and MECP2) in male Sj[ouml]gren's patients. Detecting 
aberrant expression and/or activity of these genes also offer a 
potential singular test for diagnosing Sj[ouml]gren's in male subjects.
    Potential Applications:
     Singular diagnostic test to diagnose Sj[ouml]gren's.
     Therapeutic target to develop treatment for 
Sj[ouml]gren's.
    Competitive Advantages:
     Currently no single test available to diagnose 
Sj[ouml]gren's.
     Currently there is no cure for Sj[ouml]gren's; present 
palliative treatments only reduce symptoms (e.g., moisture replacement 
therapy for eyes and mouth, and systemic anti-inflammatory or 
immunosuppressive agents for more advanced forms of disease).
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
     In vivo data available (human).
    Inventor: John Chiorini (NIDCR).
    Publication: Dix DJ, et al. Targeted gene disruption of Hsp70-2 
results in failed meiosis, germ cell apoptosis, and male infertility. 
Proc Natl Acad Sci USA. 1996 Apr 16;93(8):3264-8. [PMID 8622925].
    Intellectual Property: HHS Reference No. E-232-2011/0-US-01--U.S. 
Provisional Application No. 61/540,364 filed 28 Sep 2011.
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected].
    Collaborative Research Opportunity: The NIDCR is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize BMP6 Based 
Diagnosis and Treatment of Sj[ouml]gren's. For collaboration 
opportunities, please contact David W. Bradley, Ph.D. at 
[email protected].

Use of PAMP (Proadrenomedullin N-Terminal 20 Peptide) and PAMP 
Inhibitors for the Treatment of Cancer, Cardiovascular Disease, and 
Other Angiogenesis-Related Diseases

    Description of Technology: This technology details the use of PAMP 
or PAMP derivatives as a means to induce angiogenesis in tissue, as 
well as the use of PAMP inhibitors to inhibit angiogenesis.
    PAMP (Proadrenomedullin N-terminal 20 peptide) is a 20 amino-acid 
molecule originating from the post-translational processing of pre-
proadrenomedullin. PAMP is known as a potent hypotensive and 
vasodilatory agent; however, in addition to these properties, the 
inventors have discovered that PAMP also functions as a potent 
angiogenic factor. The inventors have also shown that an inhibitory 
fragment of PAMP, PAMP (12-20), is able to delay tumor growth in 
xenograft models of tumor progression. The ability to promote 
angiogenesis can be used as a means to increase vascularization in 
specific tissue areas or to treat patients with ischemic diseases. In 
contrast, the ability to inhibit this process can be used to limit 
growth of solid tumors and as a therapy for retinopathies, 
endometriosis, or arthritis.
    Potential Commercial Applications:
     PAMP and derivatives may be used as treatments for 
ischemic disease or coronary artery disease and to promote 
vascularization in graft tissues.
     PAMP inhibitors may be used as treatments to limit growth 
of solid tumors or other angiogenesis-related disease.
    Competitive Advantages:
     PAMP exhibits a potent angiogenic potential at femtomolar 
concentrations, as opposed to nanomolar concentrations of other growth 
factors such as bFGF and VEGF.
     PAMP and PAMP inhibitors provide a new mechanism for 
modulation of angiogenesis and treatment of angiogenesis-related 
diseases.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventor: Frank F Cuttitta (NCI).
    Publication: Martinez A, et al. Proadrenomedullin NH2-terminal 20 
peptide is a potent angiogenic factor, and its inhibition results in 
reduction of tumor growth. Cancer Res. 2004 Sep 15;64(18):6489-94. 
[PMID 15374959].
    Intellectual Property: HHS Reference No. E-294-2002/0--
     US Patent No. 7,462,593, Issued 09 Dec 2008.
     US Patent No. 7,862,815, Issued 04 Jan 2011.
     Foreign counterparts in Australia, Canada, and Japan.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].

Methods for Measuring Adrenomedullin and Monitoring and Treating 
Adrenomedullin-Mediated Diseases, Such as Diabetes and Cancer

    Description of Technology: The technology includes methods for 
utilizing purified adrenomedullin (AM)-binding proteins, or functional 
portions thereof, to diagnose, treat, and monitor AM-related diseases 
such as diabetes and cancer. Antibodies and small-molecule antagonists, 
which can down-regulate the function of AM, Complement Factor-H (CFH), 
and the AM-CFH complex, have also been isolated.
    AM is a ubiquitously-expressed peptide that functions as a 
universal autocrine growth factor. AM drives cell proliferation, acts 
as a vasodilator, can protect cells against oxidative stress in hypoxic 
injury, and acts as a dose-dependent inhibitor of insulin secretion. 
Methods for measuring in vivo levels of AM accurately and regulating 
the activity of available AM may be critically important in diagnosis 
and treatment of many conditions, such as heart disease, pulmonary 
disease, cirrhosis, cancer, diabetes, sepsis, and inflammation.
    This technology centers on the observation that AM binds to CFH in 
vivo. Without a means to determine the amount of AM that is bound to 
CFH, measurements of AM are inaccurate. Furthermore, therapies focused 
on the AM-CFH complex may have advantages over therapies focused on AM 
alone.
    Potential Commercial Applications:
     Methods for diagnosis and treatment of conditions, such as 
cancer, diabetes, or other conditions influenced by AM levels.
     AM-specific antibodies could be used in a diagnostic assay 
to measure levels of AM.
    Competitive Advantages:
     More accurate measurements of serum adrenomedullin than 
current tests.
     Targeting AM-CFH decreases bioavailable AM, provides an 
additional pathway for modulating angiogenesis.
    Development Stage:
     Pre-clinical.
     In vitro data available.
     In vivo data available (animal).
    Inventor: Frank F Cuttitta (NCI).
    Publications:
    1. Mart[iacute]nez A, et al. Mapping of the adrenomedullin-binding 
domains in human complement factor H. Hypertens Res. 2003 Feb;26 
Suppl:S55-9. [PMID 12630812 ]
    2. Pio R, et al. Complement factor H is a serum-binding protein for 
adrenomedullin, and the resulting complex modulates the bioactivities 
of both partners. J Biol Chem. 2001 Apr 13;276(15):12292-300. [PMID 
11116141]
    3. Miller MJ, et al. Adrenomedullin expression in human tumor cell 
lines. Its potential role as an autocrine growth factor. J Biol Chem. 
1996 Sep 20;271(38):23345-51. [PMID 8798536]

[[Page 70791]]

    Intellectual Property: HHS Reference No. E-256-1999/0--
     PCT Application No. PCT/US00/24722 filed 08 Sep 2000.
     US Patent No. 7,659,081 issued 09 Feb 2010.
     US Patent No. 7,993,857 issued 09 Aug 2011.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].

    Dated: November 20, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-28630 Filed 11-26-12; 8:45 am]
BILLING CODE 4140-01-P