Government-Owned Inventions; Availability for Licensing, 72450-72452 [E5-6802]
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Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices
Evaluation and Research (mail stop
5411), Food and Drug Administration,
10903 New Hampshire Ave., bldg. 22,
Silver Spring, MD 20993, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 23,
2002 (67 FR 3060), FDA published a
final rule establishing criteria and
procedures for additional conditions to
become eligible for consideration in the
OTC drug monograph system. These
criteria and procedures, codified in
§ 330.14 (21 CFR 330.14), permit OTC
drugs initially marketed in the United
States after the OTC drug review began
in 1972 and OTC drugs without any
marketing experience in the United
States to become eligible for FDA’s OTC
drug monograph system. The term
‘‘condition’’ means an active ingredient
or botanical drug substance (or a
combination of active ingredients or
botanical drug substances), dosage form,
dosage strength, or route of
administration, marketed for a specific
OTC use (§ 330.14(a)). The criteria and
procedures also permit conditions that
are regulated as cosmetics or dietary
supplements in foreign countries but
that would be regulated as OTC drugs in
the United States to become eligible for
the OTC drug monograph system.
Sponsors must provide specific data
and information in a TEA to
demonstrate that the condition has been
marketed for a material time and to a
material extent to become eligible for
consideration in the OTC drug
monograph system. When the condition
is found eligible, FDA publishes a
notice of eligibility and request for
safety and effectiveness data for the
proposed OTC use. The TEAs that FDA
reviewed (Refs. 1 and 2) and FDA’s
evaluation of the TEAs (Refs. 3 and 4)
have been placed on public display in
the Division of Dockets Management
(see ADDRESSES) under the docket
number found in brackets in the
heading of this document. Information
deemed confidential under 18 U.S.C.
1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j)
(section 301(j) of the Federal Food,
Drug, and Cosmetic Act) was deleted
from the TEAs before they were placed
on public display.
II. Request for Comments, Data, and
Information
17:14 Dec 02, 2005
Jkt 208001
III. Marketing Policy
Under § 330.14(h), any product
containing the conditions for which
data and information are requested may
not be marketed as an OTC drug in the
United States at this time unless it is the
subject of an approved new drug
application or abbreviated new drug
application.
IV. References
FDA has determined that the
information submitted in this TEA
satisfies the criteria of § 330.14(b). FDA
will evaluate bisoctrizole, up to 10
percent, and bemotrizinol, up to 10
percent, as sunscreen single active
VerDate Aug<31>2005
ingredients and in combination with
other existing monograph sunscreen
active ingredients, for inclusion in the
monograph for OTC sunscreen drug
products (21 CFR part 352).
Accordingly, FDA invites all interested
persons to submit data and information,
as described in § 330.14(f), on the safety
and effectiveness of these ingredients as
single active ingredients for this use so
that FDA can determine whether they
can be GRAS/E and not misbranded
under recommended conditions of OTC
use. Additional data should be included
to establish the safety and effectiveness
of sunscreen drug products containing a
combination of bisoctrizole and/or
bemotrizinol with other existing
sunscreen monograph active
ingredients.
Neither of the TEAs included an
official or proposed United States
Pharmacopeia-National Formulary
(USP–NF) drug monograph. According
to § 330.14(i), an official or proposed
USP–NF monograph for each ingredient
must be included as part of the safety
and effectiveness data for these
ingredients. Interested parties should
provide an official or proposed USP–NF
monograph for each ingredient.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments, data, and information.
Submit three copies of all comments,
data, and information. Individuals
submitting written information or
anyone submitting electronic comments
may submit one copy. Submissions are
to be identified with the docket number
found in brackets in the heading of this
document and may be accompanied by
supporting information. Received
submissions may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Information submitted after the closing
date will not be considered except by
petition under 21 CFR 10.30.
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
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1. TEA’s for bisoctrizole submitted by
CIBA Specialty Chemicals Corp., April
11, 2005.
2. TEA’s for bemotrizinol submitted
by CIBA Specialty Chemicals Corp.,
April 11, 2005.
3. FDA’s evaluation and comments on
the TEA for bisoctrizole.
4. FDA’s evaluation and comments on
the TEA for bemotrizinol.
Dated: November 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23576 Filed 12–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
Modified Recombinant Anti-Tumor
RNase
Dianne L. Newton, David F. Nellis,
Susanna M. Rybak (NCI)
U.S. Provisional Application filed 30
Sep 2005 (HHS Reference No. E–265–
2005/0-US–01)
Licensing Contact: Jesse Kindra; 301/
435–5559; kindraj@mail.nih.gov.
Members of the ribonuclease A
(RNase A) superfamily such as
Onconase or rapLR1 have potential for
clinical use either alone, combined with
drugs, or as the toxic component of
targeted therapy. In targeted therapies,
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices
the RNase is conjugated to a targeting
moiety, such as an antibody. Typically
the RNase is chemically modified before
it can be linked to another molecule.
These methods usually require a large
excess of unmodified RNase. The
current invention provides genetically
modified thiol-containing RNase
molecules that can be used in much
lower amounts to generate chemical
conjugates. Additionally, the inserted
thiol group provides the advantage of a
site-directed and specific attachment of
the RNase to targeting moieties. The
invention also provides methodologies
for generating cysteine-modified RNase
conjugates and methods of using such
conjugates.
Methods and Compositions for the
Inhibition of SARS-CoV Replication
Propagation and Transmission
Sharon M. Wahl and Gang Peng
(NIDCR)
U.S. Provisional Application No. 60/
713,724 filed 06 Sep 2005 (HHS
Reference No. E–253–2005/0-US–01)
Licensing Contact: Michael Shmilovich;
301/435–5019;
shmilovm@mail.nih.gov.
Available for licensing and
commercial development is a method of
inhibiting SARS-CoV replication,
propagation and transmission using 2cyano-3,12-dioxooleana-1,9-dien-28-oic
(CDDO). Severe acute respiratory
syndrome (SARS) is an infectious
atypical pneumonia that has recently
been recognized in patients in 32
countries and regions. The atypical
pneumonia with unknown etiology was
initially observed in Guangdong
Province, China. This observation was
followed by reports from Hong Kong,
Vietnam, Singapore, Canada and Beijing
of severe febrile respiratory illness that
spread to household members and
health care workers. This disease was
later designated ‘‘severe acute
respiratory syndrome (SARS)’’ by the
World Health Organization (WHO).
Until May 19, 2003, a cumulative total
of 7,864 SARS cases were reported to
WHO from 29 countries. A total of 643
deaths (case-fatality proportion: 8.2%)
were reported.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Methods of Treating and Preventing
Renal Cancer Using a Dimethane
Sulfonate Compound
Drs. Susan Mertins, David Covell and
Geoffrey Patton (STB, NCI-Fredrick),
Melinda Hollingshead (BTB, DTB,
NCI-Fredrick), B. Rao Vishnuvajjala
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17:14 Dec 02, 2005
Jkt 208001
(PRB, DTP, NCI-Bethesda), and Susan
Bates (CTB, CCR, NCI-Bethesda).
HHS Reference No. E–249–2005/0-PCT–
01
Licensing Contact: George G. Pipia; 301/
435–5560; pipiag@mail.nih.gov.
Currently only a few small molecule
inhibitors are effective in patients with
renal cell carcinoma. Approximately
30,000 patients per year are diagnosed
with this disease but many of them are
untreatable because of intrinsic drug
resistance, and efficient drug transport
and detoxification mechanisms. This
invention described and claimed in the
patent application describes a series of
dimethane sulfonate compounds based
on NSC 281612 that are suitable for the
treatment of renal cancer. Compositions
comprising a pharmaceuticallyacceptable carrier and a compound, or
a salt suitable for use in the treatment
or prevention of renal cancer are also
described. The anti-tumor activity of
NSC 281612 has been established in
vivo against human renal tumor
xenografts in mice. Suitable dosing and
administration schedules for treatment
of renal tumors have also been
determined in this study.
Noncovalent HIV Env-CD4 Complexes
for Generation of Broadly Neutralizing
Antibodies
Jinhai Wang and Michael Norcross
(FDA)
U.S. Provisional Application No. 60/
711,985 filed 25 Aug 2005 (HHS
Reference No. E–173–2005/0-US–01)
Licensing Contact: Susan Ano; 301/435–
5515; anos@mail.nih.gov.
HIV vaccine technology based on HIV
envelope protein (Env) have been less
successful than anticipated to date. One
possible reason for this is the potential
conformational masking of neutralizing
epitopes. The current technology
combines HIV Env and cell surface
polypeptides CD4 in non-covalent
complexes to expose epitopes not
present on the uncomplexed Env
molecules. These complexes can thus be
used to elicit neutralizing antibodies
when used as vaccines, immunogenic
compositions or immunotherapies. The
CD4 inducing epitopes found in regions
of the virus that are most conserved
across clades are unmasked, thus
making this technology potentially
effective against HIV viruses from
several clades. Additionally, cell surface
polypeptide CD4 is in its native
conformation and masked by Env,
therefore it is unlikely to induce
autoantibodies.
In addition to licensing, the
technology is available for further
development through collaborative
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72451
research opportunities with the
inventors. If you are interested in
additional information on this
collaborative opportunity, please
contact Ms. Beatrice A. Droke at
bdroke@oc.fda.gov.
Synthesis of Indenoisoquinoliniums
and Methods of Use
Yves Pommier et al. (NCI).
PCT Application No. PCT/US2005/
08491 filed 15 Mar 2005 (HHS
Reference No. E–058–2005/0-PCT–
02).
Licensing Contact: George G. Pipia; 301/
435–5560; pipag@mail.nih.gov.
The technology relates to compounds
and methods for treating cancer.
Specifically, novel Topoisomerase I
(Top I) inhibitors are disclosed. Top I is
a DNA-modifying enzyme whose
activity is required for viability of
rapidly dividing cells such as cancer
cells. Top I is a target of the potent anticancer drug Camptothecin, which
inhibits Top I activity. However,
camptothecin-based cancer therapies
can produce side effects caused by
toxicity of camptothecin.
The disclosed compounds are
substituted indenoisoquinolinium
compounds that inhibit Top I activity.
The compounds exhibit anti-cancer
activity and have chemical properties
that may facilitate the development of
novel anti-cancer therapies with
reduced toxicity.
Confocal Fiber-Optic Laser Method for
Intraocular Lens Power Measurement
Ilko K. Ilev (FDA).
U.S. Provisional Application No. 60/
668,239 filed 03 Mar 2005 (HHS
Reference No. E–039–2005/0-US–01)
Licensing Contact: Michael Shmilovich;
301/435–5019;
shmilovm@mail.nih.gov.
Available for licensing and
commercial development is a novel
apertureless fiber-optic laser confocal
design. Intraocular lens (IOL) dioptic
power is a fundamental parameter
whose precise measurement is of critical
importance for characterizing and
evaluating the effectiveness and safety
of IOL’s. The present invention relates
to a simple, accurate, objective, quick
and relatively inexpensive method for
IOL power measurement. The principle
of operation of this method is based on
an apertureless fiber-optic laser confocal
design. The key element in this design
is a single-mode optical fiber coupler
that simultaneously performs several
essential functions. First, it provides
effective launching and delivery of the
input laser emission. Second, the fiber
tip serves as a point light source used
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Federal Register / Vol. 70, No. 232 / Monday, December 5, 2005 / Notices
for formation of a collimated Gaussian
laser beam profile for IOL testing. Third,
the tip serves as a highly sensitive point
receiver of the back reflectance laser
emission. Fourth, the fiber coupler
provides delivery of the spatially
separated back reflected laser emission
to a detector system. The combination of
these unique features of the confocal
fiber-optic laser method provides high
accuracy (exceeding 1 µm) in spatially
locating the IOL focal point and
measuring the IOL power. A unique
feature of this method is that it allows
for measurement of a wide range of both
positive and negative powers including
high-magnification IOL’s with power
greater than ±20 diopters. The simple
and high-sensitive IOL power testing
method will provide the CDRH/FDA
and the scientific community with an
independent source of measurement
data and information for evaluating the
effectiveness and safety of novel IOL
products.
Minimally Immunogenic Variants of
SDR-Grafted Humanized Antibody
CC49 and Their Use
Syed Kashmiri (NCI), Jeffrey Schlom
(NCI), and Eduardo Padlan (NIDDK)
U.S. Provisional Application No. 60/
493,903 filed 29 Aug 2003 (HHS
Reference No. E–323–2003/0-US–01)
and PCT Application No. PCT/US04/
28004 filed 27 Aug 2004 (HHS
Reference No. E–323–2003/0-PCT–
02).
Licensing Contact: Michelle Booden;
301/451–7337;
boodenm@mail.nih.gov.
Tumor Associated Glycoprotein 72
(TAG)–72 is an oncofetal antigen
expressed on a majority of human
carcinomas, including colorectal,
gastric, pancreatic, breast, lung, and
ovarian. The murine monoclonal
antibody (mAb) CC49 specifically
recognizes TAG–72 and has a higher
affinity for TAG–72 than its
predecessor, B72.3.
The present invention relates to
humanized monoclonal antibodies that
have high binding affinity for the tumorassociated glycoprotein (TAG)–72 with
minimal immunogenicity. This antiTAG–72 antibody binds to the same
epitope as the CC49 murine variant
developed at the National Cancer
Institute. The variants of CC49
described in this patent application
have been shown to have a decreased
immune response, with comparable
binding affinity, than the parent murine
antibodies.
These variants have potential benefits
for use in the detection and/or treatment
of a range of human carcinomas. Certain
fields of use may not be available.
VerDate Aug<31>2005
17:14 Dec 02, 2005
Jkt 208001
Please contact OTT for information
regarding the availability of specific
fields of use. This variant was published
in Kashmiri et al., ‘‘Minimizing
Immunogenicity of the SDR-grafted
Humanized Antibody CC49 by Genetic
Manipulation of the Framework
Residues,’’ Molecular Immunology, 40
(2003), 337–349.
Restenosis/Atherosclerosis Diagnosis,
Prophylaxis, and Therapy
Toren Finkel et al. (NHLBI)
U.S. Patent No. 6,183,752 issued 06 Feb
2001 (HHS Reference No. E–258–
1994/0-US–01)
Licensing Contact: Fatima Sayyid; 301/
435–4521; sayyidf@mail.nih.gov.
This technology relates to the
compositions and methods for the
diagnosis, prevention, and therapy of
restenosis and atherosclerosis. It
involves the use of an agent for
decreasing viral load, preferably a
vaccine, against cytomegalovirus (CMV)
and p53, including a method for
providing the therapy and administering
the agent. This invention thus relates to
stimulating an immune response,
preferably a cellular immune response,
directed against CMV and p53 to inhibit
or prevent restenosis, atherosclerosis,
and smooth muscle proliferation.
Therefore, the technology offers
methods for inducing cell death with
the purpose of inhibiting smooth muscle
proliferation as a means of preventing or
treating restenosis and atherosclerosis.
Dated: November 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–6802 Filed 12–2–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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.
Mitotic Spindle ASPM as a Diagnostic
Marker for Neoplasia and Uses Thereof
Paul K. Goldsmith, Vladmir Larionov,
Natalay Kouprina and John I. Risinger
(NCI)
U.S. Provisional Application No. 60/
696,212 filed 01 Jul 2005 (HHS
Reference No. E–210–2005/0–US–01)
Licensing Contact: Mojdeh Bahar; 301/
435–2950; baharm@mail.nih.gov.
Cancer is responsible for
approximately 23% of deaths in the
United States of America. A high
percentage of these deaths are caused by
the lack of a precise diagnostic method
that can detect malignancy in a
particular tissue at an early stage. This
invention provides for diagnostic
methods, compositions, and kits that are
useful for identifying neoplasia by
measuring Abnormal Spindle-like
Microcephaly associated (ASPM)
expression in a patient sample. The
ASPM gene is the human ortholog of the
Drosophila melanogaster ‘abnormal
spindle’ gene (asp), which is essential
for normal mitotic spindle function in
embryonic neuroblasts. By measuring
ASPM expression levels one can also
determine if a particular subject has a
higher propensity to develop neoplasia.
This invention is particularly useful in
detecting neoplasia in hard to diagnose
cancers like ovarian and uterine cancer.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Monoclonal Antibodies That Bind or
Neutralize Hepatitis B Virus
Robert H. Purcell (NIAID) et al.
U.S. Provisional Application No. 60/
644,309 filed 14 Jan 2005 (HHS
Reference No. E–144–2004/0-US–01)
Licensing Contact: Chekesha S.
Clingman; 301/435–5018;
clingmac@mail.nih.gov..
Hepatitis B virus (HBV) chronically
infects over 300 million people
worldwide. Many of them will die of
chronic hepatitis or hepatocellular
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]]>Agencies
[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72450-72452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-6802]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
Modified Recombinant Anti-Tumor RNase
Dianne L. Newton, David F. Nellis, Susanna M. Rybak (NCI)
U.S. Provisional Application filed 30 Sep 2005 (HHS Reference No. E-
265-2005/0-US-01)
Licensing Contact: Jesse Kindra; 301/435-5559; kindraj@mail.nih.gov.
Members of the ribonuclease A (RNase A) superfamily such as
Onconase[supreg] or rapLR1 have potential for clinical use either
alone, combined with drugs, or as the toxic component of targeted
therapy. In targeted therapies,
[[Page 72451]]
the RNase is conjugated to a targeting moiety, such as an antibody.
Typically the RNase is chemically modified before it can be linked to
another molecule. These methods usually require a large excess of
unmodified RNase. The current invention provides genetically modified
thiol-containing RNase molecules that can be used in much lower amounts
to generate chemical conjugates. Additionally, the inserted thiol group
provides the advantage of a site-directed and specific attachment of
the RNase to targeting moieties. The invention also provides
methodologies for generating cysteine-modified RNase conjugates and
methods of using such conjugates.
Methods and Compositions for the Inhibition of SARS-CoV Replication
Propagation and Transmission
Sharon M. Wahl and Gang Peng (NIDCR)
U.S. Provisional Application No. 60/713,724 filed 06 Sep 2005 (HHS
Reference No. E-253-2005/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019;
shmilovm@mail.nih.gov.
Available for licensing and commercial development is a method of
inhibiting SARS-CoV replication, propagation and transmission using 2-
cyano-3,12-dioxooleana-1,9-dien-28-oic (CDDO). Severe acute respiratory
syndrome (SARS) is an infectious atypical pneumonia that has recently
been recognized in patients in 32 countries and regions. The atypical
pneumonia with unknown etiology was initially observed in Guangdong
Province, China. This observation was followed by reports from Hong
Kong, Vietnam, Singapore, Canada and Beijing of severe febrile
respiratory illness that spread to household members and health care
workers. This disease was later designated ``severe acute respiratory
syndrome (SARS)'' by the World Health Organization (WHO). Until May 19,
2003, a cumulative total of 7,864 SARS cases were reported to WHO from
29 countries. A total of 643 deaths (case-fatality proportion: 8.2%)
were reported.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Methods of Treating and Preventing Renal Cancer Using a Dimethane
Sulfonate Compound
Drs. Susan Mertins, David Covell and Geoffrey Patton (STB, NCI-
Fredrick), Melinda Hollingshead (BTB, DTB, NCI-Fredrick), B. Rao
Vishnuvajjala (PRB, DTP, NCI-Bethesda), and Susan Bates (CTB, CCR, NCI-
Bethesda).
HHS Reference No. E-249-2005/0-PCT-01
Licensing Contact: George G. Pipia; 301/435-5560; pipiag@mail.nih.gov.
Currently only a few small molecule inhibitors are effective in
patients with renal cell carcinoma. Approximately 30,000 patients per
year are diagnosed with this disease but many of them are untreatable
because of intrinsic drug resistance, and efficient drug transport and
detoxification mechanisms. This invention described and claimed in the
patent application describes a series of dimethane sulfonate compounds
based on NSC 281612 that are suitable for the treatment of renal
cancer. Compositions comprising a pharmaceutically-acceptable carrier
and a compound, or a salt suitable for use in the treatment or
prevention of renal cancer are also described. The anti-tumor activity
of NSC 281612 has been established in vivo against human renal tumor
xenografts in mice. Suitable dosing and administration schedules for
treatment of renal tumors have also been determined in this study.
Noncovalent HIV Env-CD4 Complexes for Generation of Broadly
Neutralizing Antibodies
Jinhai Wang and Michael Norcross (FDA)
U.S. Provisional Application No. 60/711,985 filed 25 Aug 2005 (HHS
Reference No. E-173-2005/0-US-01)
Licensing Contact: Susan Ano; 301/435-5515; anos@mail.nih.gov.
HIV vaccine technology based on HIV envelope protein (Env) have
been less successful than anticipated to date. One possible reason for
this is the potential conformational masking of neutralizing epitopes.
The current technology combines HIV Env and cell surface polypeptides
CD4 in non-covalent complexes to expose epitopes not present on the
uncomplexed Env molecules. These complexes can thus be used to elicit
neutralizing antibodies when used as vaccines, immunogenic compositions
or immunotherapies. The CD4 inducing epitopes found in regions of the
virus that are most conserved across clades are unmasked, thus making
this technology potentially effective against HIV viruses from several
clades. Additionally, cell surface polypeptide CD4 is in its native
conformation and masked by Env, therefore it is unlikely to induce
autoantibodies.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors. If you are interested in additional information on this
collaborative opportunity, please contact Ms. Beatrice A. Droke at
bdroke@oc.fda.gov.
Synthesis of Indenoisoquinoliniums and Methods of Use
Yves Pommier et al. (NCI).
PCT Application No. PCT/US2005/08491 filed 15 Mar 2005 (HHS Reference
No. E-058-2005/0-PCT-02).
Licensing Contact: George G. Pipia; 301/435-5560; pipag@mail.nih.gov.
The technology relates to compounds and methods for treating
cancer. Specifically, novel Topoisomerase I (Top I) inhibitors are
disclosed. Top I is a DNA-modifying enzyme whose activity is required
for viability of rapidly dividing cells such as cancer cells. Top I is
a target of the potent anti-cancer drug Camptothecin, which inhibits
Top I activity. However, camptothecin-based cancer therapies can
produce side effects caused by toxicity of camptothecin.
The disclosed compounds are substituted indenoisoquinolinium
compounds that inhibit Top I activity. The compounds exhibit anti-
cancer activity and have chemical properties that may facilitate the
development of novel anti-cancer therapies with reduced toxicity.
Confocal Fiber-Optic Laser Method for Intraocular Lens Power
Measurement
Ilko K. Ilev (FDA).
U.S. Provisional Application No. 60/668,239 filed 03 Mar 2005 (HHS
Reference No. E-039-2005/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019;
shmilovm@mail.nih.gov.
Available for licensing and commercial development is a novel
apertureless fiber-optic laser confocal design. Intraocular lens (IOL)
dioptic power is a fundamental parameter whose precise measurement is
of critical importance for characterizing and evaluating the
effectiveness and safety of IOL's. The present invention relates to a
simple, accurate, objective, quick and relatively inexpensive method
for IOL power measurement. The principle of operation of this method is
based on an apertureless fiber-optic laser confocal design. The key
element in this design is a single-mode optical fiber coupler that
simultaneously performs several essential functions. First, it provides
effective launching and delivery of the input laser emission. Second,
the fiber tip serves as a point light source used
[[Page 72452]]
for formation of a collimated Gaussian laser beam profile for IOL
testing. Third, the tip serves as a highly sensitive point receiver of
the back reflectance laser emission. Fourth, the fiber coupler provides
delivery of the spatially separated back reflected laser emission to a
detector system. The combination of these unique features of the
confocal fiber-optic laser method provides high accuracy (exceeding 1
[mu]m) in spatially locating the IOL focal point and measuring the IOL
power. A unique feature of this method is that it allows for
measurement of a wide range of both positive and negative powers
including high-magnification IOL's with power greater than 20 diopters. The simple and high-sensitive IOL power testing
method will provide the CDRH/FDA and the scientific community with an
independent source of measurement data and information for evaluating
the effectiveness and safety of novel IOL products.
Minimally Immunogenic Variants of SDR-Grafted Humanized Antibody CC49
and Their Use
Syed Kashmiri (NCI), Jeffrey Schlom (NCI), and Eduardo Padlan (NIDDK)
U.S. Provisional Application No. 60/493,903 filed 29 Aug 2003 (HHS
Reference No. E-323-2003/0-US-01) and PCT Application No. PCT/US04/
28004 filed 27 Aug 2004 (HHS Reference No. E-323-2003/0-PCT-02).
Licensing Contact: Michelle Booden; 301/451-7337; boodenm@mail.nih.gov.
Tumor Associated Glycoprotein 72 (TAG)-72 is an oncofetal antigen
expressed on a majority of human carcinomas, including colorectal,
gastric, pancreatic, breast, lung, and ovarian. The murine monoclonal
antibody (mAb) CC49 specifically recognizes TAG-72 and has a higher
affinity for TAG-72 than its predecessor, B72.3.
The present invention relates to humanized monoclonal antibodies
that have high binding affinity for the tumor-associated glycoprotein
(TAG)-72 with minimal immunogenicity. This anti-TAG-72 antibody binds
to the same epitope as the CC49 murine variant developed at the
National Cancer Institute. The variants of CC49 described in this
patent application have been shown to have a decreased immune response,
with comparable binding affinity, than the parent murine antibodies.
These variants have potential benefits for use in the detection
and/or treatment of a range of human carcinomas. Certain fields of use
may not be available. Please contact OTT for information regarding the
availability of specific fields of use. This variant was published in
Kashmiri et al., ``Minimizing Immunogenicity of the SDR-grafted
Humanized Antibody CC49 by Genetic Manipulation of the Framework
Residues,'' Molecular Immunology, 40 (2003), 337-349.
Restenosis/Atherosclerosis Diagnosis, Prophylaxis, and Therapy
Toren Finkel et al. (NHLBI)
U.S. Patent No. 6,183,752 issued 06 Feb 2001 (HHS Reference No. E-258-
1994/0-US-01)
Licensing Contact: Fatima Sayyid; 301/435-4521; sayyidf@mail.nih.gov.
This technology relates to the compositions and methods for the
diagnosis, prevention, and therapy of restenosis and atherosclerosis.
It involves the use of an agent for decreasing viral load, preferably a
vaccine, against cytomegalovirus (CMV) and p53, including a method for
providing the therapy and administering the agent. This invention thus
relates to stimulating an immune response, preferably a cellular immune
response, directed against CMV and p53 to inhibit or prevent
restenosis, atherosclerosis, and smooth muscle proliferation.
Therefore, the technology offers methods for inducing cell death with
the purpose of inhibiting smooth muscle proliferation as a means of
preventing or treating restenosis and atherosclerosis.
Dated: November 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E5-6802 Filed 12-2-05; 8:45 am]
BILLING CODE 4140-01-P
