Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-02-07
2002-11-26
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C514S002600, C514S009100, C514S019300, C530S351000, C530S303000
Reexamination Certificate
active
06485480
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the treatment of disorders such as chronic viral infections, cancer and diabetes, and conditions such as inflammation, joint and muscle pain, muscle weakness, fatigue, sinus and nasal congestion, breathing difficulties, poor digestion, neuropathy, headaches, reduced mental acuity, poor memory, skin conditions, poor fitness, weight imbalances, and a variety of psychological conditions, such as mood swings, depression, anxiety, confusion and anger, and relates more particularly to the use of homeopathic dilutions of one or more growth factors to treat such disorders. Use of the homeopathic growth factors of the present invention have also surprisingly been demonstrated to increase lean muscle mass while reducing body fat, and improve overall health, fitness and mental clarity. The present invention also relates to homeopathic preparations of growth factors and delivery systems for such preparations.
BACKGROUND OF THE INVENTION
One aspect of this invention relates to the treatment of chronic viral infections by administration of homeopathic dilutions of growth factors. Chronic viral infections, such as herpes simplex virus, Epstein-Barr virus (EBV), human immunodeficiency virus (HIV), papilloma virus, Coxsackie B, hauta virus and hepatitis virus, affect signal transduction mechanisms with deleterious effects within and between the host's immune and nervous systems. During chronic viral infection, host cell signal transduction and cell cycle regulation are altered, often causing cell injury and cell death.
Viruses lack the necessary biochemical machinery to manufacture proteins and must therefore insert their genetic material into a host cell genome in order to proliferate. Viruses consist of a protein coat and genetic material. RNA viruses additionally contain reverse transcriptase, an enzyme that translates the RNA into a DNA strand before insertion in the host cell genome.
During viral infection, the protein coat binds to the host cell's surface membrane enabling viral genetic information to subsequently enter the host cell. Entry occurs via various methods, one of which is attachment to specific membrane receptors, including growth factor receptors. For example, the cell receptors for the Epstein Barr and herpes simplex type 1 viruses have been identified as the third component of the complement receptor and the fibroblast growth factor receptor, respectively. Insertion of viral genetic information into the host cell's genome subverts the cell's normal metabolic and genetic mechanisms in order to prioritize viral gene expression and replication.
Chronic, or long-term, viral infections occur when the virus overcomes or effectively disrupts the normal neuronal and immunological defense mechanisms of the host. During early infection, several viruses, such as herpes simplex virus, EBV, human herpes 6 virus (HH6V), hepatitis and HIV can be asymptomatic as immune responses and viral replication remain in balance in specific cell populations. Viral replication occurs in response to extracellular stimuli (Garcia-Blanco, M. A. and Cullen, B. R. 1991 Science 254:815-820). Infections persist as continuous viral replication occurs without substantial disruption of host cell function. Chronic viral infection s terminate only when viral replication is disrupted.
Viral infection erodes feedback communication between the host's immune and nervous systems. For example, synthesis of adrenocorticotrophic hormone (ACTH) by lymphocytes after viral infection disrupts the normal feedback loop between pituitary/hypothalamus secretion of ACTH and the adrenal gland's synthesis of glucocorticoids in response to ACTH signals. Over-expression of ACTH causes increased expression of glucocorticoids which consequentially down-regulates the pituitary and suppresses the activities of T lymphocytes. This constant stress response often leads to extreme fatigue and exhaustion in patients with chronic viral infections. In an immune compromised patient, chronic infection leads to entry of virions into the bloodstream, the lymphatic vessels and/or the nerve pathways resulting in infection of new and distant cell populations.
Long-term DNA viral infections correlate with chronic or cancerous illnesses. For example, hepatitis B viral infection was correlated with liver cirrhosis 44% of the time and primary hepatocellular carcinoma 58% of the time compared to 17% in a control group. EBV infection was correlated with Hodgkin's disease of the mixed cellularity type 60% of the time. Herpes type viral nucleic acid sequences from herpes simplex 1 and 2, cytomegalovirus and EBV was found in the cerebrospinal fluid of patients with acute encephalitis. HH6V has been found to be a cofactor in causing chronic fatigue syndrome and AIDS. The ability of viruses to cause cancer is contained within specific sequences of the viral genome, known as oncogenes, that modulate gene transcription and regulation.
Gene transcription and regulation are modulated under normal conditions by growth factors. Growth factors are cell signaling polypeptides that bind to specific cell membrane receptors and initiate a cascade of intracellular events that affect cell proliferation and differentiation. As stated above, many growth factors bind to the same cell surface receptors as viruses and therefore activate the same metabolic pathways used by viral infected or transformed cells.
There are gene sequence homologies between growth factors, proto-oncogenes and viral oncogenes. Normal non-cancer cells contain proto-oncogenes that are homologous to the oncogene sequences found in some cancer causing viruses. Proto-oncogene as well as oncogene sequences have the power to regulate the cell cycle. Growth factors regulate the cell cycle by manipulating proto-oncogenes. Some proto-oncogene sequences are homologous with growth factors or their receptors. For example, the B chain of platelet-derived growth factor (PDGF) is homologous to the proto-oncogene c-sis (Doolittle, R. F., et al. 1983 Science 221:275-77). The receptor for epidermal growth factor (EGF) is homologous to the proto-oncogene c-erbb (Downward, et al. 1984 Nature 307:521-527).
Growth factors and viruses use the same transcription sites to regulate cell proliferation and/or viral replication, and are thus in a somewhat competitive state with one another. For example, TGF&bgr; plays a critical role in the transmission of biological information by acting as an on/off switch that couples cell behavior to the external environment. Within the TGF&bgr; promoter lies the proto-oncogene c-fos which codes for key transcription factors located at AP-1 transcription sites. Subversion of c-fos gene expression by HIV enhances HIV transcription and replication independent of control sites located at tat and NF
k
&bgr; (Roebuck, K. A. et al. 1993 J. Clin. Invest. 92:1336-1348). Viral transcription in the human T-cell leukemia virus type 1 (HTLV-1), a virus with many characteristics similar to HIV, is tightly regulated by a Tax transactivator site located at the c-fos AP-1 site within the TGF&bgr; promoter (Kim et al. 1990 J. Exp. Med. 172:121-129). When the TGF&bgr; promoter is activated so is HTLV-1 Tax. Chronic viral infection coincides with aberrant expression of growth factors throughout the body as viruses have evolved to successively overcome the regulatory actions of their competitors, growth factors.
Chronic viral infections can lead to up-regulation of growth factor expression. For example, HIV infection up-regulates expression of tumor necrosis factor alpha (TNF&agr;) and transforming growth factor beta (TGF&bgr;). Over-expression of either of these growth factors disrupts normal transcriptional control of gene expression, leading to suppression of hematopoietic progenitor cells and increased HIV replication. TGF&bgr;, secreted by HIV-infected lymphocytes, also promoters growth of Kaposi's sarcoma cells, fibroblasts and endothelial cells.
Specific hemopoietic growth factors have been used to treat diseases such a
Benado Lisa N.
Casler Brian L.
Klaniecki James E.
Speckman Ann W.
Thissell Jeremy
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