60866 Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / 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); Sjo ̈rgen’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 

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 

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] 

BILLING CODE 4140–01–P 

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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