National Center for Complementary & Alternative Medicine; Notice of Closed Meeting, 60866 [07-5310]
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60866
Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / Notices
rmajette on PROD1PC64 with NOTICES
Pre-immunization prior to
engraftment with foreign tissues
prolongs graft survival time.
With molecular identification of
allergy-evoking antigens, it will be
possible to immunize in cycle with IL–
4 to induce apoptosis of T cells involved
in allergic disorders.
It is envisioned that autoimmune
diseases such as multiple sclerosis,
rheumatic fever, lupus and others can
be treated using IL–2 and the relevant
peptide to cause apoptosis of the T cells
responsible for the disease.
The fact that interleukin-2 and 4
participates in the death of a
subpopulation of T lymphocytes cells
capable of causing diseases while
leaving the majority of T lymphocyte
cells substantially unaffected enhances
the therapeutic value of these
inventions.
The use of a novel therapeutic agent,
i.e., MP4, in the treatment of MS.
Competitive Advantage of Our
Technology
Autoimmune diseases result from a
dysfunction of the immune system in
which the body attacks its own organs,
tissues and cells. More than 80
clinically distinct autoimmune diseases
have been identified, including: type-1
diabetes (300,000–500,000 cases in the
U.S.); systemic lupus erythematosus
(240,000 cases in the U.S.); multiple
sclerosis (250,000 to 350,000);
rheumatoid arthritis (2.1 million cases
in the U.S.); inflammatory bowel
diseases, including both Crohn’s disease
and ulcerative colitis (800,000 in the
U.S.); hemolytic anemia; Graves’
disease; scleroderma; psoriasis (2% to
¨
4% of the U.S. population); Sjorgen’s
syndrome, Immune Thrombocytopenic
Purpura (ITP). Collectively,
autoimmune diseases afflict 14–22
million Americans or 5% to 8% of the
United States population.
Treatment of autoimmune diseases
generally involves suppressing the
immune system, and depending on the
particular disease, different treatments
are used. To demonstrate the diversity
among these treatments consider the
following: immunosuppressants such as
azathioprine, chlorambucil,
cyclophosphamide, cyclosporine or
methostrexate are among the category of
therapeutic agents employed in treating
some autoimmune diseases.
Corticosteroids such as prednisone are
also used for both their
immunosuppressive effect and antiinflammatory activities. Tumor Necrosis
Factor Antagonists, such as Etanercept
and Infliximab are also used in treating
some autoimmune disorders. Finally,
Platelet transfusion and Plasmapheresis
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15:23 Oct 25, 2007
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are used to treat a few autoimmune
disorders.
MS is an autoimmune disease
affecting the central nervous system,
characterized by disseminated patches
of demyelination in the brain and spinal
cord, resulting in multiple and varied
neurologic symptoms and signs, usually
with remissions and exacerbations. The
currently approved drugs for MS are
different recombinant forms of
interferons and are primarily used for
the treatment of RRMS. Antegren, which
blocks cellular adhesion, is currently in
the pipeline and will be useful in
treating SPMS patients.
There is a current theoretical patient
population of approx 368,000 patients
with MS in the U.S. and approx.
450,000 in Western Europe. Considering
an estimated yearly growth rate of this
market of 0.9%, this number will
increase to approximately 390,000 by
2010 and approximately 400,000 by
2013 in the U.S. alone.
The total U.S. sales in 2003 for the top
MS drugs, i.e., Rebif, Avonex,
Betaseron, and Copaxone, was about
$1.7 billion. However, within a sixmonth period, 6–10% of the patients
have to discontinue interferon therapy.
These patients are likely to switch to
new therapies as they become available.
Thus, this is the patient population that
will benefit from the compositions
discovered at the NIH, i.e., MP4 therapy.
Patent Estate
This technology consists of the
following patents and patent
applications:
1. U.S. Patent No. 6,083,503, entitled
‘‘Interleukin-2 stimulated T lymphocyte
cell death for the treatment of
autoimmune diseases, allergic
responses, and graft rejection’’ (E–137–
1991/0–US–03);
2. U.S. Patent No. 5,989,546, entitled
‘‘Interleukin-2 stimulated T lymphocyte
cell death for the treatment of allergic
responses’’ (E–137–1991/0–US–04);
3. U.S. Patent No. 5,935,575, entitled
‘‘Interleukin-4 stimulated T lymphocyte
cell death for the treatment of allergic
disorders’’ (E–151–1992/0–US–11);
4. U.S. Patent Application No. 08/
431,644 entitled ‘‘Modified Myelin
Basic Protein Molecules’’ (E–033–1996/
0–US–01); and
5. U.S. Patent Application No. 08/
482,114 entitled ‘‘Modified Proteolipid
Protein Molecules’’ (E–128–1996/1–US–
01).
Next Step: Teleconference
There will be a teleconference where
the principal investigator will explain
this technology. Licensing and
collaborative research opportunities will
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also be discussed. If you are interested
in participating in this teleconference
please call or e-mail Mojdeh Bahar;
(301) 435–2950; baharm@mail.nih.gov.
OTT will then e-mail you the date, time
and number for the teleconference.
Dated: October 22, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E7–21104 Filed 10–25–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Alternative Medicine
Special Emphasis Panel, Developmental
Center for Research on Complementary and
Alternative Medicine.
Date: November 12–14, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Marriott at
Washingtonian Center, 204 Boardwalk Place,
Gaithersburg, MD 20878.
Contact Person: Martina Schmidt, PhD.,
Scientific Review Administrator, Office of
Scientific Review, National Center for
Complementary & Alternative Medicine,
NIH, 6707 Democracy Blvd., Suite 401,
Bethesda, MD 20892, 301–594–3456,
schmidma@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Dated: October 22, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–5310 Filed 10–25–07; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Page 60866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5310]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice
of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Center for Complementary and
Alternative Medicine Special Emphasis Panel, Developmental Center
for Research on Complementary and Alternative Medicine.
Date: November 12-14, 2007.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard Marriott at Washingtonian Center, 204 Boardwalk
Place, Gaithersburg, MD 20878.
Contact Person: Martina Schmidt, PhD., Scientific Review
Administrator, Office of Scientific Review, National Center for
Complementary & Alternative Medicine, NIH, 6707 Democracy Blvd.,
Suite 401, Bethesda, MD 20892, 301-594-3456, schmidma@mail.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Dated: October 22, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 07-5310 Filed 10-25-07; 8:45 am]
BILLING CODE 4140-01-M