[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40313-40314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14204]


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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

[[Page 40314]]

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.

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; 
[email protected].
    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 [email protected] 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; 
[email protected].
    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 [email protected] for more information.

    Dated: July 16, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-14204 Filed 7-23-07; 8:45 am]
BILLING CODE 4140-01-P