Government-Owned Inventions; Availability for Licensing, 33769-33771 [2011-14261]

Download as PDF 33769 Federal Register / Vol. 76, No. 111 / Thursday, June 9, 2011 / Notices and to verify the need for NHSC clinicians. Approval as an NHSC service site is good for three years; sites wishing to remain eligible for assignment of NHSC providers must submit a new Site Application every three years. The annual estimate of burden is as follows: Instrument Number of respondents Responses per respondent Total responses Hours per response Total burden hours NHSC Site Application ......................................................... 3,000 1 3,000 0.5 1,500 E-mail comments to paperwork@hrsa.gov or mail to the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: June 6, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–14341 Filed 6–8–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: X-Clometer: Optimizing Portable Radiography Description of Technology: The technology offered for licensing and commercial development relates to a method and apparatus that can VerDate Mar<15>2010 17:56 Jun 08, 2011 Jkt 223001 significantly improve the diagnostic performance of portable chest (CXR) and abdominal x-rays. This device quantifies angulation of a patient to provide for a better comparison of day-to-day improvement. The portable CXR is one of the most commonly requested diagnostic medical tests around the world. They are performed nearly daily on some of the sickest patients in hospitals. Paradoxically, it is well documented that portable radiography of the chest is inconsistent and often inadequate. An upright projection best evaluates effusions, rules out free air, or detects air-fluid levels. Optimally, the images are obtained at similar angles each day, even if not erect, to allow accurate comparisons and assessment of change. It is well documented that portable radiography of the chest is inconsistent and often inadequate. To achieve optimal quality of the exam the technologist attempts the most upright projection; balanced with patient condition and ability to achieve this often impossible task. Applications: Portable chest and abdominal x-rays performed at patient’s hospital bedside. Advantages • Currently, there is no quantitative marker to indicate degree of the upright position. Prior markers with small ball bearings sinking to a small circle only indicate if the patient is supine or not. This technology introduces a simple dynamic marker that can quantify the angle at a glance for the radiologist to best compare patient condition over time. This device objectively quantifies cassette angle with a ball bearing in a cylindrical tube with markers to indicate upright position in degrees. • The technology improves performance of CXR, allowing reliable comparisons of patient condition over time. Thus, better therapies can be planned and unnecessary CT (Computerized Tomography) can be prevented. • The technology improves care for Intensive Care Unit patients, as developing effusion and the need for immediate drainage (as one of many examples) can be more effectively PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 assessed with the present apparatus. A widespread use of the device will save lives through improved diagnosis and comparison of effusions. Development Status • A performance of a visual prototype was demonstrated. The visual prototype was imaged at 5 selected angles with a chest phantom. Initial in-vitro results demonstrate that angles can be quantified to within 30 degrees. • Improved prototypes with more accuracy are currently being manufactured for patient use. In-vivo studies will soon be underway to validate clinical utility. Inventors: Les R. Folio (CC) and Lucas S. Folio. Relevant Publications 1. Wandtke JC. Bedside chest radiography. Radiology. 1994; 190:1–10. [PMID: 8043058] 2. Pneumatikos I, Bouros D. Pleural effusions in critically ill patients. Respiration. 2008; 76(3):241–248. [PMID: 18824883] 3. Mattison LE, et al. Pleural effusions in the medical ICU: prevalence, causes, and clinical implications. Chest. 1997 Apr;111(4):1018–1023. [PMID: 9106583] 4. Fartoukh M, et al. Clinically documented pleural effusions in medical ICU patients: how useful is routine thoracentesis? Chest. 2002 Jan;121(1):178–184. [PMID: 11796448] 5. Bekemeyer WB, et al. Efficacy of chest radiography in a respiratory intensive care unit. A prospective study. Chest. 1985 Nov; 88(5): 691–696. [PMID: 4053711] 6. Tocino I. Chest imaging in intensive care unit. Eur J Radiol 1996 Aug;23(1):46–57. [PMID: 8872073] Patent Status: U.S. Provisional Application No. 61/452,364 filed March 14, 2011 (HHS Reference No. E–063– 2011/0–US–01). Licensing Status: Available for licensing. Licensing Contacts • Uri Reichman, PhD, MBA; 301– 435–4616; UR7a@nih.gov. • Michael Shmilovich, Esq.; 301– 435–5019; shmilovm@mail.nih.gov. Collaborative Research Opportunity: The NIH Clinical Center, Radiology and E:\FR\FM\09JNN1.SGM 09JNN1 33770 Federal Register / Vol. 76, No. 111 / Thursday, June 9, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Imaging Sciences, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize X-Clometer. Please contact Ken Rose, PhD at 301–435–3132 or rosek@mail.nih.gov for more information. treatment of obesity and type 2 diabetes. The LM will be willing to collaborate with parties to evaluate potential inhibitors using the HIF1a adiposespecific knockout mice. Please contact John Hewes, PhD at 301–435–3121 or hewesj@mail.nih.gov for more information. HIF1a-Targeted Therapy for Diabetes and Obesity Description of Technology: This technology describes the use of hypoxia inducible factor 1 alpha (HIF1a) inhibitors for the reduction of body weight and treatment of diabetes. In obesity, the rapid expansion of adipose tissue outpaces the oxygen supply, resulting in hypoxia. HIF1a, a transcription factor that plays an essential role in cellular and systemic responses to low oxygen levels, is activated in these tissues, and causes inflammation that has been linked to insulin resistance and other metabolic dysfunction. To examine the role of hypoxia in obesity and insulin resistance, investigators at the National Cancer Institute disrupted the HIF1a gene (or its dimerization partner, the HIF1b) in the adipose tissue of transgenic mice, and found that these mice were protected from obesity and insulin resistance when fed a high-fat (western) diet. In further experiments, administration of an HIF1a inhibitor to wild-type mice achieved similar reductions in fat mass and insulin resistance, as well as other indicators of metabolic disease. Thus, HIF1a inhibitors represent promising new leads for obesity and diabetes therapeutics. Applications: HIF1a-targeted therapies for type 2 diabetes and obesity. Development Status: Proof of concept has been demonstrated in mouse models. Inventors: Frank J. Gonzalez and Changtao Jiang (NCI). Relevant Publications: In preparation. Patent Status: U.S. Provisional Application No. 61/423,936, filed December 16, 2010 (HHS Reference No. E–018–2011/0–US–01). Licensing Status: Available for licensing. Licensing Contact: Tara L. Kirby, PhD; 301–435–4426; tarak@mail.nih.gov Collaborative Research Opportunity: The Center for Cancer Research, Laboratory of Metabolism (LM), is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize HIF1a inhibitors that can be used for the Synergistic Combination Agent (Ceramide and Vinca Alkaloids) for Cancer Therapy Description of Technology: Work by the Nanotechnology Characterization Laboratory (NCL), a joint initiative of NCI, NIST, and the FDA, has led to the discovery of a novel combination chemotherapy. This combination is shown to have synergistic effects on cytotoxicity to cancer cells in vitro, and to cause a substantial decrease in tumor growth in preclinical tumor models in vivo. Combination therapy using these agents may enhance the response rate of different cancers to these drugs and may significantly reduce side effects by permitting a lower therapeutic dose to be administered. The instant invention relates to a novel combination of ceramide and vinca alkaloids, which synergistically decrease cancer cell growth without increasing the toxicity profile compared to the individual drugs. The drug combination has been rigorously evaluated in both in vitro and in vivo models of cancer, and a dose rangefinding toxicology study has been conducted in rodents. This combination induces cell death via a novel mechanism (induction of autophagy with simultaneous blockade of autophagy flux). This mechanism appears to impart selectivity of the therapy to cancer cells. Available for licensing are methods to use the combination therapy for cancer treatment. Applications: Cancer treatment, especially for cancers sensitive to treatment with vinca alkaloids such as breast cancer, testicular cancer, head and neck cancer, Hodgkin’s lymphoma, and non-small cell lung cancer. Advantages: Vinca alkaloids alone at therapeutic doses produce the standard side effects of cancer chemotherapy. The vinca alkaloid-ceramide combination can be administered at lower doses with comparable efficacy and may allow for more frequent dosing (metronomic dosing). The novel mechanism of action of this combination appears to be selective to cancer cells. Development Status: The drug combination has been evaluated in both human hepatocarcinoma models (in vitro cell culture assays) and human VerDate Mar<15>2010 19:07 Jun 08, 2011 Jkt 223001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 colon cancer models (in vivo mouse xenografts). Additional in vivo studies with other cancer types and early stage preclinical toxicology studies are being planned. Inventors: Stephan T. Stern, Scott E. McNeil, Pavan Adiseshaiah (NCL/NCI) Patent Status: U.S. Provisional Patent Application No. 61/451,925 filed March 11, 2011 (HHS Reference No. E–007– 2011/0–US–01) Licensing Status: Available for licensing or partnering for further development. Licensing Contact: Betty B. Tong, PhD; 301–594–6565; tongb@mail.nih.gov Collaborative Research Opportunity: The SAIC Frederick, Nanotechnology Characterization Laboratory, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a ceramide and vinca alkaloid combination therapy for treatment of cancer. Please contact John Hewes, PhD at 301–435–3121 or hewesj@mail.nih.gov for more information. Novel Small Molecule Inhibitors for the Treatment of Huntington’s Disease Description of Technology: This technology is a collection of small molecules screened for their ability to prevent or reduce the cytotoxic effects of the protein, Huntingtin. Huntington’s disease is a neurodegenerative disorder due to a dominantly acting expansion of a CAG trinucleotide repeat in exon 1 of the Huntington (HTT) gene resulting in production of the altered (mutant) protein Huntingtin, which has a long chain of polyglutamine (poly Q) attached to the exon 1 encoded protein sequence. Clinical and statistical analyses have shown that an increased number of poly Q repetition correlates with the probability of developing the disease, with 36 to 40 being the accepted cut off number for developing the disorder with high probability. It is known that poly Q repetitions impact the physical properties of Huntingtin and cause it to produce aggregates that precipitate and form inclusion bodies, which are toxic to the neuronal cells. The compounds of this invention have been screened multiply in a neuronal cell model of Huntington’s disease containing an HTT with an expanded repeat in exon 1 of 103 Qs for their ability to inhibit cytotoxicity and protein aggregation. Applications: Treatment of Huntington’s disease. Development Status: Early development. E:\FR\FM\09JNN1.SGM 09JNN1 Federal Register / Vol. 76, No. 111 / Thursday, June 9, 2011 / Notices Inventors: Juan Marugan, Joshua McCoy, Samarjit Patnaik, Steven Titus, Wei Zheng, Noel T. Southall, Wenwei Huang (NHGRI). Relevant Publications: None. Patent Status: U.S. Provisional Application No. 61/388,482 filed September 30, 2010 (HHS Reference No. E–258–2010/0–US–01). Licensing Status: Available for licensing. Licensing Contact: Steve Standley, PhD; 301–435–4074; sstand@od.nih.gov. Collaborative Research Opportunity: The National Center for Translational Therapeutics is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology further. Please contact Ms. Lili Portilla at Lilip@nih.gov for more information. Dated: June 3, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–14261 Filed 6–8–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Intellectual and Developmental Disabilities Research Centers 2011 (P30) Review. Date: June 29–30, 2011. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. 19:07 Jun 08, 2011 Jkt 223001 Dated: June 3, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–14264 Filed 6–8–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request BILLING CODE 4140–01–P VerDate Mar<15>2010 Contact Person: Cathy J. Wedeen, PhD, Scientific Review Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01–G, Bethesda, MD 20892, 301–496–1485, wedeenc@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: Addiction Technology Transfer Centers (ATTC) National Workforce Data Collection—NEW The ATTC Network, a nationwide, multidisciplinary resource that draws upon the knowledge, experience and latest research of recognized experts in the field of addictions and behavioral health, is a unique CSAT initiative formed in 1993 in response to a shortage of well-trained addiction and behavioral health professionals in the public sector. The ATTC Network works to enhance the knowledge, skills and aptitudes of the addiction/behavioral health treatment and recovery services workforce by disseminating current health services research from the National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, National Institute of Mental Health, Agency for Health Care Policy and Research, National Institute of Justice, and other sources, as well as other SAMHSA programs. To accomplish this, the ATTC Network (1) Develops and updates state-of-the-art PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 33771 research based curricula and professional development training, (2) coordinates and facilitates meetings between Single State Authorities, Provider Associations and other key stakeholders, and (3) provides ongoing technical assistance to individuals and organizations at the local, regional and national levels. In response to the emerging shortages of qualified addiction treatment and recovery services professionals, SAMHSA/CSAT instructed the ATTC National Office to lead the ATTC Network in the development and implementation of a national addiction treatment workforce data collection effort of those individuals who work in substance use specialty treatment services. The purpose of this survey and data collection is to gather information to guide the formation of effective national, regional, state, and organizational policies and strategies aimed at successfully recruiting and retaining a sufficient number of adequately prepared providers who are able to respond to the growing needs of those affected by substance use and mental health disorders; including cooccurring disorders and trauma. This data collection will offer a unique perspective on the clinical treatment field so that CSAT and the ATTC Network can better understand current successful strategies and methodologies being used in the workforce and develop appropriate training for emerging trends in the field. Although SAMHSA/CSAT is the primary target audience for data collection findings, it is expected that the data collected and resulting reports will also be useful to the ATTC Network, as well as to Single State Agencies, provider organizations, professional organizations, training and education entities, and individuals in the workforce. Overview of Data Collection and Purposes Data will be collected from two main sources: (1) A random sample of clinical directors or a designated direct care supervisor from facilities listed in the I– SATS database. (2) A national sample of clinical directors and key thought leaders, identified by CSAT in conjunction with the ATTC network, in the substance use disorders treatment field. Respondents will be asked to participate in at least one of three (3) distinct methods. They are: • A Web-based Clinical Director Survey (also available in paper format). • On-line Focus Groups. E:\FR\FM\09JNN1.SGM 09JNN1

Agencies

[Federal Register Volume 76, Number 111 (Thursday, June 9, 2011)]
[Notices]
[Pages 33769-33771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14261]


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

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.

X-Clometer: Optimizing Portable Radiography

    Description of Technology: The technology offered for licensing and 
commercial development relates to a method and apparatus that can 
significantly improve the diagnostic performance of portable chest 
(CXR) and abdominal x-rays. This device quantifies angulation of a 
patient to provide for a better comparison of day-to-day improvement.
    The portable CXR is one of the most commonly requested diagnostic 
medical tests around the world. They are performed nearly daily on some 
of the sickest patients in hospitals. Paradoxically, it is well 
documented that portable radiography of the chest is inconsistent and 
often inadequate.
    An upright projection best evaluates effusions, rules out free air, 
or detects air-fluid levels. Optimally, the images are obtained at 
similar angles each day, even if not erect, to allow accurate 
comparisons and assessment of change. It is well documented that 
portable radiography of the chest is inconsistent and often inadequate. 
To achieve optimal quality of the exam the technologist attempts the 
most upright projection; balanced with patient condition and ability to 
achieve this often impossible task.
    Applications: Portable chest and abdominal x-rays performed at 
patient's hospital bedside.

Advantages

     Currently, there is no quantitative marker to indicate 
degree of the upright position. Prior markers with small ball bearings 
sinking to a small circle only indicate if the patient is supine or 
not. This technology introduces a simple dynamic marker that can 
quantify the angle at a glance for the radiologist to best compare 
patient condition over time. This device objectively quantifies 
cassette angle with a ball bearing in a cylindrical tube with markers 
to indicate upright position in degrees.
     The technology improves performance of CXR, allowing 
reliable comparisons of patient condition over time. Thus, better 
therapies can be planned and unnecessary CT (Computerized Tomography) 
can be prevented.
     The technology improves care for Intensive Care Unit 
patients, as developing effusion and the need for immediate drainage 
(as one of many examples) can be more effectively assessed with the 
present apparatus. A widespread use of the device will save lives 
through improved diagnosis and comparison of effusions.

Development Status

     A performance of a visual prototype was demonstrated. The 
visual prototype was imaged at 5 selected angles with a chest phantom. 
Initial in-vitro results demonstrate that angles can be quantified to 
within 30 degrees.
     Improved prototypes with more accuracy are currently being 
manufactured for patient use. In-vivo studies will soon be underway to 
validate clinical utility.
    Inventors: Les R. Folio (CC) and Lucas S. Folio.

Relevant Publications

    1. Wandtke JC. Bedside chest radiography. Radiology. 1994; 190:1-
10. [PMID: 8043058]
    2. Pneumatikos I, Bouros D. Pleural effusions in critically ill 
patients. Respiration. 2008; 76(3):241-248. [PMID: 18824883]
    3. Mattison LE, et al. Pleural effusions in the medical ICU: 
prevalence, causes, and clinical implications. Chest. 1997 
Apr;111(4):1018-1023. [PMID: 9106583]
    4. Fartoukh M, et al. Clinically documented pleural effusions in 
medical ICU patients: how useful is routine thoracentesis? Chest. 2002 
Jan;121(1):178-184. [PMID: 11796448]
    5. Bekemeyer WB, et al. Efficacy of chest radiography in a 
respiratory intensive care unit. A prospective study. Chest. 1985 Nov; 
88(5): 691-696. [PMID: 4053711]
    6. Tocino I. Chest imaging in intensive care unit. Eur J Radiol 
1996 Aug;23(1):46-57. [PMID: 8872073]
    Patent Status: U.S. Provisional Application No. 61/452,364 filed 
March 14, 2011 (HHS Reference No. E-063-2011/0-US-01).
    Licensing Status: Available for licensing.

Licensing Contacts

     Uri Reichman, PhD, MBA; 301-435-4616; UR7a@nih.gov.
     Michael Shmilovich, Esq.; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The NIH Clinical Center, 
Radiology and

[[Page 33770]]

Imaging Sciences, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize X-Clometer. Please contact Ken Rose, PhD at 
301-435-3132 or rosek@mail.nih.gov for more information.

HIF1[alpha]-Targeted Therapy for Diabetes and Obesity

    Description of Technology: This technology describes the use of 
hypoxia inducible factor 1 alpha (HIF1[alpha]) inhibitors for the 
reduction of body weight and treatment of diabetes.
    In obesity, the rapid expansion of adipose tissue outpaces the 
oxygen supply, resulting in hypoxia. HIF1[alpha], a transcription 
factor that plays an essential role in cellular and systemic responses 
to low oxygen levels, is activated in these tissues, and causes 
inflammation that has been linked to insulin resistance and other 
metabolic dysfunction.
    To examine the role of hypoxia in obesity and insulin resistance, 
investigators at the National Cancer Institute disrupted the 
HIF1[alpha] gene (or its dimerization partner, the HIF1[beta]) in the 
adipose tissue of transgenic mice, and found that these mice were 
protected from obesity and insulin resistance when fed a high-fat 
(western) diet. In further experiments, administration of an 
HIF1[alpha] inhibitor to wild-type mice achieved similar reductions in 
fat mass and insulin resistance, as well as other indicators of 
metabolic disease. Thus, HIF1[alpha] inhibitors represent promising new 
leads for obesity and diabetes therapeutics.
    Applications: HIF1[alpha]-targeted therapies for type 2 diabetes 
and obesity.
    Development Status: Proof of concept has been demonstrated in mouse 
models.
    Inventors: Frank J. Gonzalez and Changtao Jiang (NCI).
    Relevant Publications: In preparation.
    Patent Status: U.S. Provisional Application No. 61/423,936, filed 
December 16, 2010 (HHS Reference No. E-018-2011/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301-435-4426; 
tarak@mail.nih.gov
    Collaborative Research Opportunity: The Center for Cancer Research, 
Laboratory of Metabolism (LM), is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize HIF1[alpha] inhibitors that can be 
used for the treatment of obesity and type 2 diabetes. The LM will be 
willing to collaborate with parties to evaluate potential inhibitors 
using the HIF1[alpha] adipose-specific knockout mice. Please contact 
John Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

Synergistic Combination Agent (Ceramide and Vinca Alkaloids) for Cancer 
Therapy

    Description of Technology: Work by the Nanotechnology 
Characterization Laboratory (NCL), a joint initiative of NCI, NIST, and 
the FDA, has led to the discovery of a novel combination chemotherapy. 
This combination is shown to have synergistic effects on cytotoxicity 
to cancer cells in vitro, and to cause a substantial decrease in tumor 
growth in preclinical tumor models in vivo. Combination therapy using 
these agents may enhance the response rate of different cancers to 
these drugs and may significantly reduce side effects by permitting a 
lower therapeutic dose to be administered.
    The instant invention relates to a novel combination of ceramide 
and vinca alkaloids, which synergistically decrease cancer cell growth 
without increasing the toxicity profile compared to the individual 
drugs. The drug combination has been rigorously evaluated in both in 
vitro and in vivo models of cancer, and a dose range-finding toxicology 
study has been conducted in rodents.
    This combination induces cell death via a novel mechanism 
(induction of autophagy with simultaneous blockade of autophagy flux). 
This mechanism appears to impart selectivity of the therapy to cancer 
cells.
    Available for licensing are methods to use the combination therapy 
for cancer treatment.
    Applications: Cancer treatment, especially for cancers sensitive to 
treatment with vinca alkaloids such as breast cancer, testicular 
cancer, head and neck cancer, Hodgkin's lymphoma, and non-small cell 
lung cancer.
    Advantages: Vinca alkaloids alone at therapeutic doses produce the 
standard side effects of cancer chemotherapy. The vinca alkaloid-
ceramide combination can be administered at lower doses with comparable 
efficacy and may allow for more frequent dosing (metronomic dosing). 
The novel mechanism of action of this combination appears to be 
selective to cancer cells.
    Development Status: The drug combination has been evaluated in both 
human hepatocarcinoma models (in vitro cell culture assays) and human 
colon cancer models (in vivo mouse xenografts). Additional in vivo 
studies with other cancer types and early stage preclinical toxicology 
studies are being planned.
    Inventors: Stephan T. Stern, Scott E. McNeil, Pavan Adiseshaiah 
(NCL/NCI)
    Patent Status: U.S. Provisional Patent Application No. 61/451,925 
filed March 11, 2011 (HHS Reference No. E-007-2011/0-US-01)
    Licensing Status: Available for licensing or partnering for further 
development.
    Licensing Contact: Betty B. Tong, PhD; 301-594-6565; 
tongb@mail.nih.gov
    Collaborative Research Opportunity: The SAIC Frederick, 
Nanotechnology Characterization Laboratory, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize a ceramide and 
vinca alkaloid combination therapy for treatment of cancer. Please 
contact John Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more 
information.

Novel Small Molecule Inhibitors for the Treatment of Huntington's 
Disease

    Description of Technology: This technology is a collection of small 
molecules screened for their ability to prevent or reduce the cytotoxic 
effects of the protein, Huntingtin. Huntington's disease is a 
neurodegenerative disorder due to a dominantly acting expansion of a 
CAG trinucleotide repeat in exon 1 of the Huntington (HTT) gene 
resulting in production of the altered (mutant) protein Huntingtin, 
which has a long chain of polyglutamine (poly Q) attached to the exon 1 
encoded protein sequence. Clinical and statistical analyses have shown 
that an increased number of poly Q repetition correlates with the 
probability of developing the disease, with 36 to 40 being the accepted 
cut off number for developing the disorder with high probability. It is 
known that poly Q repetitions impact the physical properties of 
Huntingtin and cause it to produce aggregates that precipitate and form 
inclusion bodies, which are toxic to the neuronal cells. The compounds 
of this invention have been screened multiply in a neuronal cell model 
of Huntington's disease containing an HTT with an expanded repeat in 
exon 1 of 103 Qs for their ability to inhibit cytotoxicity and protein 
aggregation.
    Applications: Treatment of Huntington's disease.
    Development Status: Early development.

[[Page 33771]]

    Inventors: Juan Marugan, Joshua McCoy, Samarjit Patnaik, Steven 
Titus, Wei Zheng, Noel T. Southall, Wenwei Huang (NHGRI).
    Relevant Publications: None.
    Patent Status: U.S. Provisional Application No. 61/388,482 filed 
September 30, 2010 (HHS Reference No. E-258-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Steve Standley, PhD; 301-435-4074; 
sstand@od.nih.gov.
    Collaborative Research Opportunity: The National Center for 
Translational Therapeutics is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize this technology further. Please 
contact Ms. Lili Portilla at Lilip@nih.gov for more information.

    Dated: June 3, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-14261 Filed 6-8-11; 8:45 am]
BILLING CODE 4140-01-P

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