Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-12-09
2004-04-06
Zitomer, Stephanie W. (Department: 1634)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S014800, C514S017400, C530S312000, C530S327000, C530S330000
Reexamination Certificate
active
06716810
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition and method for regulation of body weight and conditions related thereto, and particularly, to uses of proopiomelanocortin (POMC) peptides and analogs thereof to control body weight and conditions related thereto.
BACKGROUND OF THE INVENTION
The regulation of body weight, and particularly, obesity and conditions related thereto, is a major health concern throughout the world, and particularly in the United States, contributing to morbidity and mortality. Obesity is a metabolic disorder characterized by excessive accumulation of fat stores in adipose tissue. In humans, its causes are a complex interplay of genetics, environment and culture. It is well known that a regimen of diet and exercise leading to weight loss is the best approach for treating obesity, but unfortunately, such regimens are frequently unsuccessful. Oftentimes, an individual's inability to lose weight may be due to genetically inherited factors that contribute to increased appetite, a preference for high calorie foods, reduced physical activity and an abnormal metabolism. People inheriting or acquiring such predispositions are prone to obesity regardless of their efforts to combat the condition.
On the other side of the spectrum of body weight problems, other individuals suffer from one or:more “wasting” disorders (e.g., wasting syndrome, cachexia, sarcopenia) which cause undesirable and/or unhealthy loss of weight or loss of body cell mass. In the elderly as well as in AIDS and cancer patients, wasting disease can result in undesired loss of body weight, including both the fat and the fat-free compartments. Wasting diseases can be the result of inadequate intake of food and/or metabolic changes related to illness and/or the aging process. Cancer patients and AIDS patients, as well as patients following extensive surgery or having chronic infections, immunologic diseases, hyperthyroidism, extraintestinal Crohn's disease, psychogenic disease, chronic heart failure or other severe trauma, frequently suffer from wasting disease which is sometimes also referred to as cachexia, a metabolic and, sometimes, an eating disorder. Cachexia is additionally characterized by hypermetabolism and hypercatabolism. Although cachexia and wasting disease are frequently used interchangeably to refer to wasting conditions, there is at least one body of research which differentiates cachexia from wasting syndrome as a loss of fat-free mass, and particularly, body cell mass (Mayer, 1999,
J. Nutr.
129(1S Suppl.): 256S-259S). Sarcopenia, yet another such disorder which can affect the aging individual, is typically characterized by loss of muscle mass. End stage wasting disease as described above can develop in individuals suffering from either cachexia or sarcopenia.
In addition to the obvious health risks associated with being overweight or underweight, the tangential detrimental effects of such conditions are equally troublesome. For the obese individual, health effects can include a myriad of physical conditions related to, or affected by, excess body weight (e.g., cardiovascular disease, diabetes, cancer, hypertension, etc.) as well as physiological damage due to an overweight person's loss of self-esteem, depression, etc. For example, obesity, and particularly upper body obesity, is frequently associated with NIDDM. Non-insulin dependent diabetes mellitus (NIDDM or Type II diabetes) is a metabolic disorder that is characterized by the failure of body tissues to store carbohydrates at a normal rate. Resistance to the action of insulin is the most common characteristic of a Type II diabetic. When this resistance exceeds the capacity of the insulin-producing beta cells of the Islets of Langerhans to produce insulin, clinical diabetes results. In addition to NIDDM, being overweight, even in the absence of clinical obesity, can significantly increase the risk of developing certain other conditions, and/or of exacerbating the symptoms associated with the condition once developed. For example, the risk of inquiring several forms of cancer is increased in obese patients. Such cancers include breast cancer and colon cancer. Moreover, it has been known for years that excess body weight can be a risk factor for cardiovascular disease, hypertension, stroke and gall bladder disease. Obesity can also contribute to the risk of acquiring, or exacerbating, respiratory problems and osteoarthritis.
Other conditions that are frequently associated with excess gain of body weight are affective and mood disorders, including atypical depression or dysthymia. Some patients may alternatively experience undesired loss of body weight. It has previously been shown that in patients with an affective disorder characterized by higher than normal levels of HPA axis activity, leptin levels are also increased from normal levels in the blood of such patients (U.S. Pat. No. 5,866,547 to Flier et al., incorporated herein by reference in its entirety). High cerebrospinal fluid (brain) leptin levels are needed to suppress the increased activity of the HPA axis in these patients.
Another factor which can significantly contribute to an individual's propensity to gain weight and/or an inability to lose weight may be a side effect associated with one or more pharmaceutical compounds that the individual is taking to treat another condition. For example, epilepsy, attention deficit hyperactivity disorder (ADHD), and recently, migraine, are often treated with the drug, valproic acid, also known commercially as Depakote, which has the well known and undesirable side affect of increasing body weight. Other drugs having a similar side effect include lithium, commonly used for bipolar disorder (manic depression) and a several other antidepressants, including tricyclic antidepressants and several selective serotonin reuptake inhibitors (SSRIs) including fluoxetine, also known commercially as Prozac. There are a number of other drugs which have similar side effects, or the opposite side effect (i.e., undesired loss of body weight), including many drugs used for chemotherapy. Indeed, Such side effects can have serious implications for the patient's compliance with the drug therapy, as well as the patient's general well being and health. Indeed, many patients are likely to choose a lower body weight and greater self esteem over the treatment of what can be a disabling and destructive disorder, which reduces the ability of both patient and physician to maintain control over the disorder. When the disorder is a bipolar disorder, for example, non-compliance can be life-threatening.
For the underweight individual, conditions related to or affected by low body weight can include heart failure, susceptibility to infectious disease as a result of immune system weakness, and depression. Moreover, the rise in bulemia and anorexia in the past few decades is alarming, and illustrates the disturbing emphasis on ideal body size and shape regardless of the severe health consequences.
In 1963, Kennedy and Mitra proposed that puberty is linked to body weight and more specifically, to fat storage which is concluded to be one of the signals responsible for the initiation of hypothalamic control of ovarian function (
J. Physiol.
166:408). Other researchers have proposed that the loss or restoration of menstrual cycles in young girls is related to a minimum weight for height (Frisch and McArthur, 1974,
Science
185:949). Frisch and McArthur proposed that normal girls become relatively fatter from menarche to reproductive maturity. Taken together, these studies indicate that there is a relationship between the initiation of reproduction and adiposity. In support of this relationship were the observations that very lean young female ballet dancers and college rowers have a delayed puberty (Frisch et al., 1980,
NEJM
303:17 and Frisch et al., 1981 ,
JAMA
246:1559), whereas obese girls have an acceleration of puberty (Zacharias et al., 1970,
Am. J. Obs. Gyn.
108:833). The amenorrhea of extremely lean
Brennan Miles B.
Hochgeschwender Ute
Brinks Hofer Gilson & Lione
Eleanor Roosevelt Institute
Zitomer Stephanie W.
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