Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Blood
Reexamination Certificate
2000-03-31
2004-10-05
Nolan, Patrick J. (Department: 1644)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Blood
C424S093100, C424S093700, C424S520000, C424S810000, C424S192100, C424S278100, C514S825000, C514S885000
Reexamination Certificate
active
06800300
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to medical treatments for autoimmune and alloimmune diseases, and more specifically to treatments comprising two components: a first component comprising a treatment which brings about a remission of a particular autoimmune or alloimmune disease and/or one or more symptoms associated with the disease; and a second component comprising administration of modified mammalian blood to effectively maintain remission of the disease and/or its symptoms.
BACKGROUND OF THE INVENTION
Autoimmune diseases are generally believed to be caused by the failure of the immune system to discriminate between antigens of foreign invading organisms (non-self) and tissues native to its own body (self). When this failure to discriminate between self and non-self occurs and the immune system reacts against self antigens, an autoimmune disorder may arise. Autoimmune diseases, or diseases having an autommune component, include rheumatoid arthritis, multiple sclerosis, systemic lupus erythromatosis (SLE), scleroderma, diabetes, inflammatory bowel disease, psoriasis and atherosclerosis. “Alloimmune diseases” are referred to herein as disorders such as graft versus host disease and tissue transplant rejection, in which an immune response against or by foreign, transplanted tissue can lead to serious complications or be fatal. In the treatment of these disorders, it is desired to prevent the body from reacting against non-self antigens.
While treatments are available which alleviate and bring about remission of autoimmune and alloimmune diseases and/or the symptoms associated with these diseases, many of these treatments do not treat the underlying cause of the disease and therefore must be continued indefinitely in order to maintain their beneficial effect.
Rheumatoid arthritis is an example of a common human autoimmune disease, affecting about 1% of the population. This disease is characterized by chronic inflammation of the synovial joints which may lead to progressive destruction of cartilage and bone.
Although there is no known cure for rheumatoid arthritis, a variety of drug treatments are currently available to alleviate symptoms of the disease and to slow the permanent and irreversible joint degradation associated with the disease. For example, treatment with non-steroidal anti-inflammatory drugs (NSAIDS) or glucocorticoids may provide relief of joint pain and swelling; disease-modifying anti-rheumatic drugs (DMARDS) such as hydroxychloroquine, methotrexate, sulfasalazine, D-penicillamine, gold (chrysotherapy) and azathioprine may be combined with NSAIDS and/or glucocorticoids to delay disease progression; and cyclosporines may be used to treat patients who do not respond to other therapies. Also known are type IV phosphodiesterase inhibitors, some of which have been shown to down-regulate the production of tumor necrosis factor-&agr; (TNF-&agr;).
A new class of agents under investigation are the biologic TNF inhibitors, which include soluble TNF receptors, recombinant TNF receptors and anti-TNF monoclonal antibodies. These agents inhibit the action of TNF, a pro-inflammatory cytokine. TNF is responsible for much of the inflammation and joint destruction in rheumatoid arthritis, both directly, by inducing inflammation, and indirectly, by mediating the cascade of other pro-inflammatory cytokines.
Specific examples of recombinant TNF receptors include recombinant human TNF receptor p55 Fc fusion protein (p55 TNFR:Fc) and recombinant human TNF receptor p75 Fc fusion protein (p75 TNFR:Fc), the latter being a dimeric form of the p75 TNF receptor created by fusion to the Fc fragment of human immunoglobulin IgG1. The p55 and p75 TNFR:Fc bind to soluble TNF present in the synovial fluid of a patient suffering from rheumatoid arthritis, thereby reducing its inflammatory action and resulting in a significant reduction in joint tenderness and swelling.
The above-mentioned drug treatments are typically administered to patients after the onset of rheumatoid arthritis, and may slow progression of the disease and provide some degree of relief from the symptoms associated with the disease. However, these drug treatments fail to address the underlying cause of rheumatoid arthritis which, as with autoimmune and alloimmune diseases in general, is an inappropriate immune response. Therefore, once these treatments are discontinued, the symptoms of rheumatoid arthritis typically re-appear. This is also true of other current drug treatments for other autoimmune and alloimmune disorders.
The use of drug treatments on a long-term basis can be costly and may have undesirable side effects and should therefore be avoided. Consequently, the need exists for alternate treatments which avoid the long-term use of drugs while providing long-term relief from symptoms of auto immune and alloimmune diseases such as rheumatoid arthritis.
SUMMARY OF THE INVENTION
The present invention provides a novel method of treating autoimmune and alloimmune diseases which provides advantages over previously known treatments, such as those discussed above for the treatment of rheumatoid arthritis.
The method of treatment according to the invention comprises a combination therapy for administration to a subject after the onset of an autoimmune or alloimmune disease in that subject. One component of the therapy comprises administration of a drug treatment to bring about at least a partial remission of the disease and/or one or more of the symptoms associated with the disease. Preferably, the drug treatment is one which does not have an effect on the underlying immune response of the subject but, as with the biologic TNF inhibitors mentioned above, blocks the effector stage of the immune response.
The other component of the combination therapy comprises administering to the subject autologous mammalian blood which has been modified extracorporeally by exposure to at least one stressor selected from the group consisting of an oxidative environment, an electromagnetic emission and a temperature above or below body temperature.
Mammalian blood modified in this manner has been shown to be effective for preventing the onset of autoimmune diseases. In this regard, see U.S. Pat. No. 5,980,954 to Bolton, issued on Nov. 9, 1999, entitled “Treatment of Autoimmune Diseases”, which is incorporated herein in its entirety.
A possible mechanism by which modified mammalian blood alleviates autoimmune and alloimmune diseases is discussed in detail in above-mentioned U.S. Pat. No. 5,980,954. This mechanism involves T-cells, a type of lymphocyte which play a significant role in the control of the immune system. T-cells include CD-8 cells, and CD-4 cells otherwise known as T-helper cells that are further subdividable into TH1 and TH2 cells. TH1 cells secrete pro-inflammatory cytokines such as interferon gamma, which leads to the production of TNF-&agr;. On the other hand, TH2 cells are considered to be regulatory cells and secrete regulatory cytokines, such as interleukins-4 and -10. In a normal, healthy individual, the ratio of TH1 cells to TH2 cells is about 3:1. In individuals suffering from an autoimmune or alloimmune condition, there is usually an imbalance in the TH cell types, often with an increase in the ratio of TH1 cells to TH2 cells, as in rheumatoid arthritis, which is believed to result in inflammatory conditions often noted in autoinimune diseases such as rheumatoid arthritis. It is believed that a number of components of modified autologous mammalian blood, upon re-injection into the patient, upregulate the proportion of TH2 cells in a patient's blood, thereby increasing the secretion of regulatory cytokines and preventing the secretion of abnormal amounts of pro-inflammatory cytokines and the consequent appearance of symptoms such as inflammation commonly associated with autoimmune and alloimmune diseases.
Therefore, the present invention provides a combination therapy for autoimmune and alloimmune diseases in which remission of the disease is reduced with certain drug therapies, and administration of modif
Miller Richard G.
Rabinovich Brian
Nolan Patrick J.
Vasogen Ireland Limited
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