[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40138-40139]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy06-111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Convection Enhanced
Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to
the Central Nervous System
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive worldwide license to practice the invention embodied: HHS.
Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of
Therapeutic Agents,'' Provisional Patent Application, 60/413,673;
International Patent Application PCT/US03/30155, U.S. Patent
Application Serial No. 10/528,310; European Patent Applications Serial
No. 03756863.1; Australian Patent Application No. 2003299140; Canadian
Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and/1
``Method for Increasing the Distribution of Therapeutic Agents;'' and
``Method for Increasing the Distribution of Nucleic Acids;''
Provisional, Patent Application 60/250,286; Provisional Patent
Application No. 60/286,308; U.S. Patent Application No. 09/999,203;
U.S. Patent Application No. 10/132,681; and Canadian Patent Application
No. 2327208, to MedGenesis Therapeutix, Inc. a Canadian company having
its headquarters in Victoria, British Columbia. The United States of
America is the assignee of the patent rights of the above invention.
The contemplated exclusive license may be granted in a field of use
limited to the convection enhanced delivery and tracking of gadolinium
conjugated peptides, polypeptides or lipid-based therapeutic agents
within the central nervous system of subjects with cancer, Parkinson's
disease, Dementia with Lewy bodies or Alzheimer's disease.
DATES: Only written comments and/or applications for a licence received
by the NIH Office of Technology Transfer on or before September 12,
2006.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael A. Shmilovich, Esq., Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: shmilovm@mail.nih.gov. A
signed confidentiality nondisclosure agreement will be required to
receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent applications intended for
licensure disclose and/or cover the following:
E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic
Agents.'' The invention is a method for monitoring the spatial
distribution of therapeutic substances by MRI or CT that have been
administered to tissue using convection enhanced delivery, a technique
that is the subject of NIH-owned U.S. Patent No. 5,720,720. In one
embodiment, the tracer is a molecule, detectable by MRI or CT, which
functions as a surrogate for the motion of the therapeutic agent
through the solid tissue. In other particular embodiments, the tracer
is the therapeutic agent conjugated to an imaging moiety. The method of
this invention uses non-toxic macromolecular MRI contrast agents
comprised of chelated Gd(III). In particular, the surrogate tracer used
in this invention is a serum albumin conjugated with either a
gadolinium chelate of 2-(p-isothiocyanotobenzyl)-6-
methyldiethylenertriamine pentaacetic
[[Page 40139]]
acid or with iopanioc acid. These macromolecular imaging agents have
clearance properties that mimic the pharmacokinetic properties of co-
administrated drugs, so as to be useful in quantifying the range and
dosage level of therapeutic drugs using MR imaging.
E-206-2000 ``Method for increasing the distribution of therapeutic
agents:'' ``Method for increasing the distribution of nucleic acids.''
The invention pertains to the reliance of therapies on the local
parenchymal delivery of macromolecules or nucleic acids for success.
However, the volume of distribution of many of these potential
therapeutic agents is restricted by their interactions with the
extracellular matrix and cellular receptors. Heparin-sulfate
proteoglycans are cell surface components which bind to an array of
molecules such as growth factors, cytokines and chemokines and viruses
such as cytomegalovirus, herpes simplex virus and HIV. The invention
provides a method of dramatically increasing the volume of distribution
and effectiveness of certain therapeutic agents after local delivery by
the use of facilitating agents as described in Neuroreport. 2001 Jul
3;12(9):1961-4 entitled ``Convection enhanced delivery of AAV-2
combined with heparin increases TK gene transfer in the rat brain'' and
in Exp Neurol. 2001 Mar;168(1):155-61 entitled ``Heparin coinfusion
during convection-enhanced delivery (CED) increases the distribution of
the glial-derived neurotrophic factor (GDNF) ligand family in rat
striatum and enhances the pharmacological activity of neurturin.''
These methods are especially useful when used in conjunction with
technology described and claimed in the convection enhanced delivery
technology claimed in U.S. patent 5,720,720
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license may be granted unless, within sixty
(60) days from the date of this published notice. NIH receives written
evidence and argument that establishes that the grant of the license
would not be consistent with the requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response to
this notice will not be made available for public inspection, and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: July 5, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer,
Office of Technology Transfer, National Institutes of Health.
[FR Doc. 06-6213 Filed 7-13-06; 8:45 am]
BILLING CODE 4140-01-M