[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Notices]
[Pages 42064-42065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18009]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by agencies 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.

Detection of Mutational Frequency in Human Bone Marrow

Neal S. Young et al. (NHLBI)
DHHS Reference No. E-320-2002 filed 06 Nov 2002
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected]

    To date there have been no adequate methods to determine the 
frequency of mutations in humans. This invention discloses a method of 
measuring the mutational frequency of a mitochondrial DNA sequence by 
sequencing mitochondrial DNA from clonally expanded single cells such 
as CD34+ human stem cells. Sequencing for mitochondrial DNA 
polymorphisms and mutations may also be useful as a general method to 
detect minimal residual disease in leukemia. The mitochondrial genome 
is particularly susceptible to mutations and these may be used to 
measure genomic mutagenesis by virtue of comparison. The application of 
this invention includes the determination of mutational frequency after 
chemotherapy, radiation, environmental toxic exposure and genetic 
disease. The invention also provides a screening for an agent that has 
a mutagenic effect on a cell.

Structurally Rigid Dopamine D3 Receptor Selective Ligands as Cocaine 
and Methamphetamine Abuse Therapeutics

Amy Newman et al. (NIDA)
DHHS Reference No. E-251-2002/0-US-01 filed 14 Sep 2002
Licensing Contact: Norbert Pontzer; 301/435-5502; [email protected]

    The dopamine D3 receptor subtype has been implicated in a number of 
central nervous system (CNS) disorders including but not limited to 
drug abuse, schizophrenia and Parkinson's disease. Since D3 receptor 
ligands show efficacy in animal models of cocaine self-administration 
and Parkinson's disease, there has been a significant effort to design 
and develop novel dopamine D3 ligands. However most currently known 
compounds are highly lipophilic, leading to poor bioavailablility and 
toxicity, or are not highly D3 selective.
    The present invention provides a family of structurally rigid, 
potent and selective D3 receptor antagonists and partial agonists with 
lowered lipophilicity. Bioavailable compounds that bind with high 
affinity and selectivity to D3 receptors can not only provide important 
tools with which to study the structure and function of this receptor 
subtype, but may also have therapeutic uses in psychiatric, behavioral 
and neurologic disorders. More information on these potential 
therapeutic agents was recently published in Newman et al., Bioorganic

[[Page 42065]]

Medicinal Chemistry Letters 13 (2003) 2179-2183.

Oral Treatment of Hemophilia

Oral Alpan et al. (NIAID)
DHHS Reference No. E-281-2001/0-PCT-02 filed 02 Aug 2002 (PCT/US02/
24544)
Licensing Contact: Fatima Sayyid; 301/435-4521; [email protected]

    This invention portrays a simple method for treatment of antigen-
deficiency diseases by orally administering to a subject a 
therapeutically effective amount of the deficient antigen, wherein the 
antigen is not present in a liposome. This method increases hemostasis 
in a subject having hemophilia A or B, by orally administering to the 
hemophiliac a therapeutically effective amount of the appropriate 
clotting factor, sufficient to induce oral tolerance and supply 
exogenous clotting factor to the subject.

Long-Acting Insulinotropic Peptides and Uses Thereof

Dr. Josephine Egan et al. (NIA)
Serial No. 60/309,076 filed 31 Jul 2001; PCT/US02/24141 filed 30 Jul 
2002
    Licensing Contact: Pradeep Ghosh; 301/435-5282; 
[email protected]

    Type-2 diabetes and neurodegeneration (e.g., Alzheimer's disease, 
Parkinson's disease, peripheral neuropathy, stroke) are leading causes 
of death in the United States and worldwide. The present invention 
pertains to the disclosure of novel peptide analogues of Glucagons-like 
peptide-1 (GLP-1) and Exendin-4 and their uses in the treatment of (i) 
diabetes and (ii) neurodegenerative disorders.
    (i) Type-2 diabetes is caused by dysfunction of the pancreatic beta 
cells that may result in concomitant decrease in insulin production. 
Insulin replacement has been an effective therapy for the treatment of 
Type-2 diabetes. However, insulin therapy, although life saving, does 
not restore normal levels of glucose and postprandial levels of glucose 
continues to be excessively high in individuals on insulin therapy. 
Further, the therapy may result in adverse effects including 
hyperglycemia, hypoglycemia, metabolic acidosis and ketosis. Therefore, 
a better therapeutic formula may be needed that may increase the 
efficacy of the treatment and minimize the side effects. The present 
invention discloses a method of treating a subject with diabetes with 
novel GLP-1/Exendin-4 peptides. These are GLP-1 agonists and elicit 
insulinotropic actions.
    (ii) The GLP-1 receptor is additionally found in the brain as well 
as associated to pancreatic islets cells. Its stimulation in brain has 
been found to be neurotrophic and neuroprotective in both tissue 
culture and in vivo against a variety of toxic insults. Peptides of the 
said invention possess activity in a variety of predictive models of 
neurodegeneration, and may have potential in a variety of diseases both 
associated (peripheral neuropathy) and unassociated (Alzheimer's 
disease, Parkinson's disease, stroke and peripheral neuropathy) with 
diabetes (J. Alz. Dis. 4: 487-96, 2002; J. Pharmacol. Exp. Ther. 
300:958-66, 2002 & 302:881-888, 2002, TIPS in press).
    In conclusion, compounds of the present patent application possess 
potent insulinotrophic, neuroprotective and neurotrophic effects that 
derive from their GLP-1 agonist action and may have a great market 
potential as therapeutic agents for the treatment of diabetes and/or 
neurodegenerative disorders.

    Dated: July 10, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health
[FR Doc. 03-18009 Filed 7-15-03; 8:45 am]
BILLING CODE 4140-01-P