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Government-Owned Inventions; Availability for Licensing

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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 Start Printed Page 40314applications 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.

Cytochrome P450 Inhibitors for Treatment of Cocaine-Induced Fetal Brain Injury

Description of Technology: It is estimated that one percent of pregnant women use cocaine at some point in their pregnancies. In addition to increased risk for complications during pregnancy such as stillbirth, stroke, and low birth weight, cocaine appears to affect both short-term and long-term mental development. Animal studies indicate changes in brain development and behavior in response to prenatal cocaine exposure, and research has shown that children exposed to cocaine before birth are at risk of learning and behavioral problems. Children exposed to cocaine before birth are twice as likely to have significant delays in mental skills by age two. Treatment for pregnant women who use cocaine is typically directed to cocaine avoidance, but these treatments do not directly address the problem of cocaine-induced damage in the developing fetus, particularly in the fetal brain. Thus, there exists a critical need for drugs that can prevent or treat cocaine-induced damage to the fetal brain.

The inventors have demonstrated that N-oxidative metabolism of cocaine causes oxidative stress to the endoplasmic reticulum, which ultimately results in cell cycle arrest and abnormal development of the fetal cerebral cortex. They have also shown that cytochrome P450 inhibitors can block the inhibition of cell proliferation by cocaine. This invention discloses methods of using cytochrome P450 inhibitors to treat or prevent cocaine-induced fetal brain injury, as well as methods for screening for inhibitory drugs to treat or prevent cocaine-induced fetal brain injury.

Applications: Development of cytochrome P450-based therapeutics for fetal brain injury caused by cocaine exposure; Assay to screen for new drugs that prevent cocaine-induced fetal brain injury.

Development Status: The inventors plan to test cytochrome P450 inhibitors in animal models.

Inventors: Chun-Ting Lee and William Freed (NIDA).

Publication: In preparation.

Patent Status: U.S. Provisional Application No. 60/893,218 filed 06 Mar 2007 (HHS Reference No. E-025-2007/0-US-01).

Licensing Status: This technology is available for exclusive, co-exclusive, or nonexclusive licensing.

Licensing Contact: Tara L. Kirby, PhD; 301/435-4426; tarak@mail.nih.gov.

Collaborative Research Opportunity: The Cellular Neurobiology Research Branch of the National Institute on Drug Abuse is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the development of P450 inhibitors and related compounds for the prevention of cocaine-induced developmental brain damage Please contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for more information.

Methods and Materials for Identifying Polymorphic Variants, Diagnosing Susceptibilities, and Treating Disease

Description of Technology: This invention relates to materials and methods associated with polymorphic variants in two enzymes involved in folate-dependent and one-carbon metabolic pathways important in pregnancy-related complications and neural tube birth defects: MTHFD1 (5,10-methylenetetrahydrofolate dehydrogenase, 5,10-methylenetetrahydrofolate cyclohydrolase, 10-formyltetrahydrofolate synthase) and methylenetetrahydrofolate dehydrogenase (NADP + dependent) 1-like (MTHFD1L). These enzymes are extremely important in the promotion of DNA synthesis, a process that is critical for normal placental and fetal development.

Recently, the inventors have discovered that a MTHFD1 polymorphism is also a maternal genetic risk factor for placental abruption, premature separation of a normally implanted placenta. This polymorphism may also be a risk factor for first and second trimester miscarriages. Diagnostic and therapeutic methods are provided in this invention involving the correlation of polymorphic variants in MTHFD1 and MTHFD1L and other genes with relative susceptibility for various pregnancy-related and other complications such as cancer, cardiovascular disease, developmental anomalies and psychiatric illnesses. Both nutrient status and genetic background are independent yet interacting risk factors for impaired folate metabolism. However, the mechanisms that lead to pathology or the mechanisms whereby folate prevents these disorders are unknown. Therefore, a diagnostic and therapeutic invention of this kind would significantly improve the detection and treatment of disorders associated with folate metabolism.

Inventors: Lawrence C. Brody (NHGRI) et al.

Publications:

1. A Parle-McDermott et al. MTHFD1 R653Q polymorphism is a maternal genetic risk factor for severe abruptio placentae. Am J Med Genet A. 2005 Feb 1;132(4):365-368.

2. A Parle-McDermott et al. A polymorphism in the MTHFD1 gene increases a mother's risk of having an unexplained second trimester pregnancy loss. Mol Hum Reprod. 2005 Jul;11(7):477-480.

3. A Parle-McDermott et al. Confirmation of the R653Q polymorphism of the trifunctional C1-synthase enzyme as a maternal risk for neural tube defects in the Irish population. Eur J Hum Genet. 2006 Jun;14(6):768-772.

4. B Kempisty et al. MTHFD 1958G>A and MTR 2756A>G polymorphisms are associated with bipolar disorder and schizophrenia. Psychiatr Genet. 2007 Jun;17(3):177-181.

Patent Status: International Application No. PCT/US2005/21288 filed 16 Jun 2005, which is published as WO 2007/001259 on 04 Jan 2007 (HHS Reference No. E-149-2005/0-PCT-01).

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Tara L. Kirby, PhD; 301/435-4426; tarak@mail.nih.gov.

Collaborative Research Opportunity: The National Human Genome Research Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Claire Driscoll at 301-402-2537 or cdriscol@mail.nih.gov for more information.

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Dated: July 16, 2007.

Steven M. Ferguson,

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

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[FR Doc. E7-14204 Filed 7-23-07; 8:45 am]

BILLING CODE 4140-01-P