Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Reexamination Certificate
2000-10-20
2002-11-26
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
C424S600000, C424S617000, C424S635000, C424S639000, C424S646000, C424S653000, C424S630000, C514S788100
Reexamination Certificate
active
06485755
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to pharmaceutical compositions including at least one metal oxide, such as an electron active metal oxide, and methods of using such compositions, for the prevention, treatment, and management of cancer and conditions or diseases related to the presence of cancer or a predisposition to cancer.
BACKGROUND OF THE INVENTION
Cancers are a leading cause of death in animals and humans. The exact cause of cancer is not known, but links between certain factors, such as smoking or exposure to carcinogens including tobacco smoke and chromium (VI), exposure to radiation, such as from x-rays, radioisotopes, and ultra-violet light, viruses, such as papaloma, Espstein Barr, and Raus sarcoma virus and the incidence of certain types of cancers and tumors has been shown by a number of researchers. Genetic factors and genome defects such as those found a chromosome 11 have also been linked to cancer. Traditional methods of cancer therapy include treatment with chemotherapeutic agents that inhibit cell division or radiation therapy that disrupts DNA in dividing cells. These treatments, however, may also adversely affect normal cells that happen to be dividing or synthesizing DNA at the time of treatment. Dosage levels low enough to insure survival of a cancer patient often are not sufficiently cytotoxic to tumor cells to retard continuing cell division after treatment. Additionally, the mechanism for the action of these chemotherapeutic agents is frequently unknown, which complicates the safe and effective use of these agents. Several different cancers and conditions associated with cancer are discussed below as examples illustrating the importance of combating cancer and associated conditions.
Breast carcinoma is the most common malignancy among women and shares with lung carcinoma the highest fatality rate of all cancers affecting females. For example, approximately one of every 11 women in the U.S.A. will develop breast cancer. For white women, the probability is about 1 in 10; for African American women, the rate is close to 1 in 14. The annual mortality rate from 1930 to the present has remained fairly constant at about 27 deaths per 1000,000 females, and is slightly higher for whites than African Americans.
In women, breast carcinoma is rare before age 30 but the incidence rises rapidly after menopause. Post-menopausal breast masses are typically considered cancerous until biopsy proves otherwise. Cystosarcoma phyllodes, which are a non-cancerous tumor, are the most common tumor of the breast; other malignancies are significantly more rare. Breast cancer in men is rare and tends not to be recognized until late with poor therapeutic results.
Most breast cancers, including those frequently designated as scirrhus, infiltrative, papillary, ductile, medullary, and lobular, appear as a slowly growing, painless mass, though a vague discomfort may be present. Physical signs typically include a retracted nipple, bleeding from the nipple, a distorted areola or breast contour, skin dimpling over the lesion, attachment of the mass to surrounding tissue, including the underlying fascia and overlying skin, edema of the skin of the breast with an orange peel appearance, and axillary or supraclavicular lymph nodes. In advanced cases, skin nodules with ultimate breakdown and ulcer formation may be seen.
The presence of metastases should always be suspected as the disease metastasizes by direct extension and via the lymph system and the bloodstream. Among the most common sites are the lungs and pleura, the skeleton (especially skull, spine, and pelvis), and the liver. Although the exact causes of breast cancer are not known, a doctor from France discovered a virus called mice breast tumor virus (vtmr) in 1985 that was later described as an oncomavirus with particules type B. This virus caused breast cancer in mice breast. It can be transmitted by breast milk or it can be incorporated in the human genome. Current treatments for breast cancer in general include surgery, radiotherapy, chemotherapy and hormonal therapy.
Cervical cancer includes those cancer moieties which are indigenous to the cervix. These cancer moieties are referred to generally as cervical carcinomas of which 85-90% are squamous cell carcinomas, and the balance are largely adenocarcinomas. The severity of cervical cancers are gauged by the clinical tests called PAP smears which indicate whether the carcinoma cells are confined to the cervix or have penetrated beyond it but not to the pelvic wall, or to the pelvic wall itself and even beyond the pelvis. Cervical cancers kill about 33% of their victims annually in the United States.
Carcinoma of the uterine cervix, the second most common malignancy of the female reproductive tract, most commonly affects women aged 40 to 56 years old. The incidence is higher among women from lower socioeconomic groups and among those with a history of early and frequent coitus and multiple sexual partners. Recently, venereal transmission of human papilloma virus (hpv) and herpes virus type 2 (nsv-2) have been implicated as important in the etiology of cervical neoplasia.
The earliest histologic change in what is considered a continuum from normal to invasive cancer is minimal cervical dysplasia, in which abnormal cell proliferation occurs in the lower third of the epithelium. Most of the minimal dysplasias are self-limiting and regress to normal tissue. Most severe dysplasias in the upper two-thirds of the epithelium showing abnormal proliferation, however, progress to carcinoma in situ, in which a full thickness of the epithelium contains abnormal calls. When cancer cells penetrate the basement membrane and invade the stroma (invasive carcinoma) they can spread by direct extension to adjacent pelvic organs or by lymphatic permeation and dissemination.
Of cervical carcinomas, 85 to 90% are squamous cell carcinoma. These vary from well-differentiated cells with keratinization to the highly anaplastic spindle cells of cervical tumors. Adenocarcinomas, observed in only 10 to 15% of cases, are more rare.
Early cervical neoplasia can be detected pre-clinically by cytologic examination of cervical smears obtained during routine annual pelvic examinations. At this stage, the disease is asymptomatic. The cervical smears (pap test) can detect 90% of early cervical neoplasias. Thus, the use of cervical smears has reduced the death rate from cervical cancer by more than 50% through recognition and treatment of pre-invasive neoplasia. Treatment of cervical cancer typically involves conization, radiotherapy, surgical therapy, and chemotherapy.
For diagnostic and prognostic purposes, the results of cervical smear tests may be grouped into four categories: class I characterized by the absence of observed abnormal cells; class II characterized by the presence of atypical cells and usually associated with inflammation; class III characterized by the presence of cells representative of or suspicious of carcinoma; and classes IV and V each characterized by the presence of carcinoma cells.
Additionally, the clinical stage or progression of the cervical carcinoma may be further characterized as follows. Stage 0 is characterized by carcinoma in situ with intra epithelial carcinoma. Stage I includes carcinomas strictly confined to the cervix. Stage IA is characterized by micro invasive carcinoma and stage IB is characterized by occult cancer.
In stage II, the carcinoma extends beyond the cervix but not onto the pelvic wall. Stage IIA exhibits no obvious parametrial involvement while stage IIB exhibits obvious parametrial involvement. In stage III, the carcinoma extends onto the pelvic wall. Stage IIIA is characterized by the lack of extension onto the pelvic wall and stage IIIB is characterized by extension onto the pelvic wall.
In stage IV, the carcinoma has extended beyond the true pelvis or has clinically involved the mucosa of the bladder. Stage IVA is characterized by the spread of the growth to adjacent organs. Stage IVB is characterized by the spread to distant organs.
Skin cancer
Choi Frank
Dees Jose′ G.
Marantech Holding
Pennie & Edmonds LLP
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