Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – C-o-group doai
Reexamination Certificate
2000-06-15
2003-11-11
Padmanabhan, Sreeni (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
C-o-group doai
C514S730000, C514S728000, C514S717000, C514S678000, C514S725000, C514S258100, C514S248000, C514S458000, C514S562000, C514S025000
Reexamination Certificate
active
06646013
ABSTRACT:
BACKGROUND OF THE INVENTION
Human studies demonstrate that cancer is largely a preventable disease and that 35-40% of cancer incidence and mortality worldwide can be substantially reduced by changes in the human diet. Specifically, there is compelling worldwide evidence of an association between fruit and vegetable consumption and cancer risk reduction. Other human and animal diseases, as well, are influenced by diet and can be substantially reduced by changes in diet. Examples include diabetes (especially type II diabetes), cardiovascular diseases, Alzheimers disease, osteoporosis, and many others. Likewise, other physical conditions that involve bodily attributes or performance issues, other than diseases, may be affected by diet. The present invention relates to nutrient formulations useful in reducing (including preventing, delaying, inhibiting and/or treating) cancers and other human and animal (especially mammalian) diseases and physical conditions, methods of using such formulations, and methods of identifying such formulations and the components (particularly nutrient ingredients) to be included in the formulations to achieve optimal disease reduction.
As one disease example, tumor development in cancers (carcinogenesis) proceeds through a series of multiple overlapping stages, including initiation (change in DNA), promotion (proliferation of cells with damaged DNA) and progression (growth of cells with cumulative genetic changes, including changes in key control genes that lead to malignant cells and to the emergence of a clinically detectable cancer). Since cancer development may take from 10-30 years, a preferred cancer risk reduction strategy is to insure optimum cellular and tissue health and to minimize cellular events involved in the tumor development process in healthy individuals (typically including those of ages 20-44 or younger) during the early phases of potential or actual carcinogenesis. In one aspect of the invention, this is achieved by the preferably regular, systematic and long-term administration of one or more formulations having multiple active components that, in combination, provide focused antioxidant protection and oxidative balance in the subject. These antioxidant/oxidative balance formulations of the invention provide a particularly useful approach in reducing the risk of cancer diseases generally. In another aspect of the invention, the nutrient formulation contains nutrient components specifically identified and selected to reduce or interfere with a particular disease or disease etiology (such that of a specific cancer disease, e.g. colorectal cancer as discussed below). The invention provides a method of screening and identifying useful components for such formulations. In still another aspect of the invention, the formulations, and the method of screening their components, are directed to the reduction of multiple individual diseases.
Additional protection against disease is required with age (e.g., 45-65, and over 65 years of age) and customized doses of the nutrient formulations of the invention will typically be recommended for high-risk populations (e.g., smokers, genetic risk, cancer survivors, etc.). In the case of cancer, many of these individuals will already have initiated cells, but both promotion and progression are targets for control according to the invention. Accordingly, the nutrient formulations (and their dosage components) are designed specifically for each of the various age groups and relative risk populations.
A comparison of regional human diets with worldwide patterns of cancer incidence strongly suggests that food and nutrition affect cancer incidence and mortality, and therefore cancer risk. Epidemiologic and ecologic evidence indicates that cancer incidence varies significantly between different regions and populations around the world. The observation that the patterns of cancer are sensitive to human migration and urbanization, and the lack of simple patterns of genetic inheritance for most human cancers, indicate that cancer rates are strongly influenced by environmental factors, especially diet. Individual-level epidemiological studies (particularly cohort and case-control studies) provide specific evidence for the identity of some of the dietary patterns and food that may alter risk. Thus, data support the hypothesis that cancer is largely a preventable disease and that the incidence of cancer can be substantially reduced by modifying dietary intake.
The results of a recent report commissioned by the executive officers of the World Cancer Research Fund and the American Institute for Cancer Research estimated that 30-40% of cancer cases throughout the world are preventable by modifications of diet and nutrition [1]. (The references cited herein by reference numeral are listed in the Appendix to this specification.) There is strong and consistent evidence of an association between fruit and vegetable consumption and cancer risk reduction on a worldwide basis [1-4]. In addition, low fruit and vegetable intake is associated with 1.5 to 2 times greater risk of cancer at many sites compared with high intake. Recent reviews have evaluated the large body of evidence concerning the relationship between fruit and vegetable intake and cancer incidence [5-9]. For all cancer sites, a statistically significant protective effect of fruit and vegetable consumption is found in 128 of the 156 dietary studies [3]. The evidence is strongest for lung cancer [5, 8]. In addition, fruit and vegetable consumption is associated with decreased risk for cancers of the pancreas, breast, stomach, colorectal, bladder, cervix, ovaries and endometrium [3].
Evidence now indicates that several types of cancer develop through the progressive acquisition and accumulation of mutations in multiple genes [10, 11]. Genetic mutations can be initiated via a variety of cellular events that are triggered by environmental factors. For example, genotoxic carcinogens or their metabolites act as mutagens by covalently modifying DNA, resulting in chemical changes in the genetic material. In addition, endogenously formed reactive oxygen species (ROS) and metabolites of nitrogen oxide also contribute to DNA damage.
Experimental studies have shown that tumor development proceeds through a series of multiple overlapping stages [12] defined as initiation (changes in DNA), promotion (expansion of numbers of cells with non-repaired or mis-repaired genes) and progression (growth of cells with accumulated genetic changes, some of which are in key genes that lead to cells that are aggressively malignant). In both experimental animal models and humans, there is a latency period between the original carcinogenic event and the development of a malignant tumor. This latency period may be due to several factors, including the complexity of the multistage tumor development process and/or the host's range of natural defenses against the carcinogenesis process. This long latency period and the multi-stage tumor development process provide multiple opportunities for intervention to prevent and/or delay the development of malignant tumors (i.e., risk reduction).
Numerous scientific studies offer compelling evidence that formulations of mixtures of individual compounds acting at multiple stages of carcinogenesis are most likely to be optimal for cancer risk reduction. For example, epidemiologic studies have demonstrated that diet diversity or the overall pattern of dietary intake may have a greater impact on cancer risk than any one food [435, 436]. In addition, the administration of multiple agent formulations has been shown in some cases to result in synergistic effects, i.e., increased efficacy and potency over individual components, and generally to be significantly less toxic [13-20].
To take the example of colorectal cancer, the now widely accepted adenoma-to-carcinoma progression for colorectal cancer, originally proposed by Hill [255], provides multipl
Barker Anna D.
Day Robert W.
Dennis Anthony J.
Farnsworth Norman R.
Haack Julie A.
Baker & Daniels
Jiang S.
Nutri-Logics
Padmanabhan Sreeni
LandOfFree
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