[Federal Register: January 3, 2005 (Volume 70, Number 1)]
[Notices]               
[Page 97-98]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja05-65]                         

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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 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.

Novel Compounds and Methods for Treating Alzheimer's and Related 
Diseases

Nigel H. Greig et al. (NIA)
U.S. Provisional Application filed 22 Oct 2004 (DHHS Reference No. E-
172-2004/0-US-01)
Licensing Contact: Norbert Pontzer; (301) 435-5502; 
pontzern@mail.nih.gov.

    The brain cholinergic system is thought to play an important role 
in learning and memory. The loss of cholinergic neurons early in the 
course of Alzheimer's Disease may thus be an etiological factor in the 
cognitive decline that is the hallmark of that disease. Therefore, 
potentiating cholinergic transmission has been the main pharmacological 
approach for the treatment of AD patients. Inhibition of 
acetylcholinesterase (AChE) or butyrylcholinesterase (BChE) enhances 
cholinergic transmission by reducing enzymatic degradation of 
acetylcholine.
    AChE inhibitors are now used clinically to help restore cognitive 
function in AD patients. However the therapeutic index for inhibition 
of AChE is quite low. Drugs with this mechanism of action have to have 
the proper pharmacodynamic properties to achieve even a marginally 
useful clinical effect without unacceptable side effects. The presence 
of BChE in brain tissue makes this enzyme another possible target for 
increasing the activity of the cholinergic system.
    The present invention provides a series of novel and potent 
tricyclic compounds that have a range of selectivity for inhibiting 
AchE, as compared to BchE, and possess neuroprotective activity in cell 
culture models. Also provided are methods of using these compounds to 
treat a number of different medical conditions such as Alzheimer's 
Disease, mild cognitive impairment, and other dementia-related 
disorders.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Novel Methods for Reducing Inflammation and Treating Diseases such as 
Parkinson's and Alzheimer's Disease

Jau-Shyong Hong et al. (NIEHS)
U.S. Provisional Application No. 60/570,566 filed 12 May 2004 (DHHS 
Reference No. E-130-2004/0-US-01)
Licensing Contact: Norbert Pontzer; (301) 435-5502; 
pontzern@mail.nih.gov.
    Activated microglia mediate inflammation in the CNS by secreting 
various cytokines and free radicals that could damage neurons. Brains 
from patients with Parkinson disease show microglia reaction, and 
previous studies by this laboratory show microglia activation leads to 
inflammation mediated dopaminergic degeneration. Thus identification of 
drugs that reduce microglia activation could prevent or reverse 
neuronal degeneration in Parkinson's Disease, Alzheimer's Disease, 
ischemia and other degenerative CNS disorders.
    Considerable research has shown the ability of various peptides to 
attenuate microglia activation and prevent neuronal degeneration in 
vitro with a bi-modal dose response curve. These peptides demonstrate 
maximum effects at femto-molar and micro-molar concentrations. These 
inventors have now discovered small-peptide and non-peptide molecules 
that also inhibit microglia and prevent neuronal degeneration with the 
same bi-modal dose response curve. The non-peptide compounds have also 
been shown to prevent dopamine neuronal degeneration in animal models. 
The present invention provides compositions and methods for inhibiting 
inflammatory mechanisms and treating inflammation-related condition by 
administering ultra-low (femto-molar) doses of at least one compound of 
the invention. These compounds include morphinans, opioid peptides, and 
the tripeptide GGF.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Multi-Domain Amphipathic Helical Peptides and Methods of Their Use

Alan Remaley et al. (NHLBI)
U.S. Provisional Application filed 15 Oct 2004 (DHHS Reference No. E-
114-2004/0-US-01)
Licensing Contact: Fatima Sayyid; (301) 435-4521; sayyidf@mail.nih.gov.

    Mutations in the ABCA1 transporter lead to diseases characterized 
by the accumulation of excess cellular cholesterol, low levels of HDL 
and an increased risk for cardiovascular disease. Currently, there are 
a wide variety of treatments for dyslipidemia, which include, but are 
not limited to,

[[Page 98]]

pharmacologic regimens (mostly statins), partial ileal bypass surgery, 
portacaval shunt, liver transplantation, and removal of atherogenic 
lipoproteins by one of several apheresis procedures.
    The present invention relates to the composition of peptides or 
peptide analogs with multiple amphipathic [alpha]-helical domains that 
promote lipid efflux from cells. It further relates to methods for 
identifying non-cytotoxic peptides that promote lipid efflux from cells 
that are useful in the treatment and prevention of dyslipidemic and 
vascular disorders. Dyslipidemic and vascular disorders amenable to 
treatment with the isolated multi-domain peptides include, but are not 
limited to, hyperlipidemia, hyperlipoproteinemia, hypercholesterolemia, 
hypertriglyceridemia, HDL deficiency, apoA-I deficiency, coronary 
artery disease, atherosclerosis, thrombotic stroke, peripheral vascular 
disease, restenosis, acute coronary syndrome, and reperfusion 
myocardial injury.

    Dated: December 22, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-28688 Filed 12-30-04; 8:45 am]

BILLING CODE 4140-01-P