[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Pages 60865-60866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Public Teleconference Regarding Licensing and Collaborative 
Research Opportunities for: Treatment of Autoimmune and Allergic 
Disorders (NIAID)

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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Technology Summary

    These technologies relate to compositions and methods useful in 
treating autoimmune diseases generally, and Multiple Sclerosis 
specifically.

Technology Description

    Scientists at the NIH have discovered a method for the treatment or 
prevention of autoimmune diseases, allergic or atopic disorders, and 
graft rejections. This method selectively induces apoptosis of disease 
causing T lymphocytes, while sparing the majority of T-cells. Cell 
death is achieved by the cyclical administration of disease specific 
antigens and IL-2.
    Further, the NIH scientists have developed compositions and methods 
for clinical assessment, diagnosis and treatment of Multiple Sclerosis 
(MS). The compositions are molecules related to the human proteolipid 
protein (PLP), and the 21.5 kDA fetal isoform of human myelin basic 
protein (MBP), including nucleic acids and polypeptides. The 
polypeptides can be used to assay T-cells for responsiveness to MBP and 
PLP epitopes. They are further useful as therapeutic agents for 
treating MS by inducing T-cell apoptosis. The inventors have 
demonstrated that treatment with MP4, a protein chimera of MBP, and a 
modified form of PLP, termed PLP4, prevented clinical symptoms of MS in 
both rodent and non-human primates. They have also completed primate 
toxicity tests demonstrating the compounds are non-toxic.
    Novel application of these methods described in these technologies 
include:
    Infusion of autoimmune disease antigen peptides reduces the 
severity of allergic diseases.

[[Page 60866]]

    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); Sj[ouml]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 anti-
inflammatory 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 six-month 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; [email protected]. 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