Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-02-18
2001-06-26
Davenport, Avis M. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C530S324000
Reexamination Certificate
active
06251863
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to symptoms associated with aging and/or neurodegenerative dysfunctions and their treatment with relaxin.
No one can avoid aging and the effects it has on our ability to think, act and feel. Many prominent conditions are associated with aging including lack of mobility and flexibility, osteoporosis, loss of skin elasticity, respiratory distress, muscle loss, memory loss, cognitive and affective impairment, osteodegenerative impairment of the joints, and cardiac failures, etc. In addition to impairment of many body functions associated with normal aging, some people develop advanced forms of these dysfunctions. For example, Alzheimer's disease and Parkinson's disease commonly afflict the elderly population.
An estimated four million Americans have Alzheimer's disease. The disease primarily affects those over 65 years of age, particularly over age 85. Women also have a greater risk of developing Alzheimer's. While there is no cure for Alzheimer's disease, the list of potential agents to treat its symptoms keep growing. For example, current attempts at treatment include cholinesterase inhibitors, ginkgo, acetyl-L-carnitine, ampakines, calcium channel blockers, antioxidants, and nerve growth factors, among others.
Parkinson's disease is another debilitating malady affecting a large segment of the elderly population. Parkinson's disease is commonly characterized by rigidity of the musculature, tremors at rest, and a serious inability to initiate movement. These symptoms are likely caused by a loss of dopamine secretion and destruction of the substantia nigra, which permits hyperactivity of the acetylcholine pathways.
Given the already large elderly population, and its sure, booming growth in the United States in the next thirty years, treatments that either cure or substantially reduce the symptoms of these widespread diseases and normal aspects of aging will become quite valuable. These treatments will enable a greater segment of the population to remain active without assistance and will reduce the staggering cost of nursing and health care for these patients.
SUMMARY OF THE INVENTION
The present invention is based on the recognition that some of the symptoms associated with aging and/or neurodegenerative dysfunctions (such as memory loss, poor cognitive function, negative behavioral patterns, and sleep disturbance) can be alleviated by relaxin, and may in fact be caused by a decrease of relaxin in the bloodstream. This lack of relaxin in the blood stream may be congenital or the result of another mechanism which suppresses the normal production or action of relaxin. In addition, relaxin stimulates and/or modulates other hormones, proteins, and vital body fluids, which all affect these symptoms. Accordingly, a method of the present invention of treating symptoms associated with aging and/or neurodegenerative disease and dysfunctions comprises administering to a patient exhibiting symptoms associated with these conditions a therapeutically effective amount of relaxin.
This recognition is based on clinical observations by the inventor of the symptoms reported by patients with fibromyalgia syndrome (FMS) when these patients take relaxin. In particular, the basic observation is that fibromyalgia patients no longer report or exhibit the same symptoms (e.g., poor memory, poor cognition, sleep disturbance, and poor behavior) when they are receiving relaxin that they report and/or exhibit without taking relaxin. In short, many or all of the symptoms associated with these conditions diminish or disappear when these patients are receiving relaxin therapy.
Many of these signs and symptoms affecting FMS patients are also symptoms affecting patients that have aged or that have Alzheimer's, Parkinson's, and/or other conditions such as ADD. Accordingly, to the extent that relaxin alleviates these symptoms in FMS patients, relaxin will alleviate the same symptoms in naturally aging patients and/or in Alzheimer's, Parkinson's, and ADD patients. This relationship primarily stems from the way that relaxin acts on different parts and pathways of the body, most notably the brain. Of course, many of these symptoms treatable with relaxin also are associated with aging, whether the symptoms stem from a particular disease or not.
REFERENCES:
patent: 4267101 (1981-05-01), Bigazzi
patent: 4624804 (1986-11-01), Voelter et al.
patent: 4656249 (1987-04-01), Tregear et al.
patent: 4835251 (1989-05-01), Burnier et al.
patent: 5089419 (1992-02-01), Kuniyuki
patent: 5108897 (1992-04-01), Steinetz et al.
patent: 5145962 (1992-09-01), Hudson et al.
patent: 5166191 (1992-11-01), Cronin et al.
patent: 5179195 (1993-01-01), Hudson et al.
patent: 5223408 (1993-06-01), Goeddel et al.
patent: 5279942 (1994-01-01), Kuniyuki
patent: 5320953 (1994-06-01), Hudson et al.
patent: 5326694 (1994-07-01), Hudson et al.
patent: 5451572 (1995-09-01), Cipolla et al.
patent: 5464756 (1995-11-01), Henner et al.
patent: 5478807 (1995-12-01), Cronin et al.
patent: 5612051 (1997-03-01), Yue
patent: 5656592 (1997-08-01), Seed et al.
patent: 5753623 (1998-05-01), Amento et al.
patent: 5759807 (1998-06-01), Breece et al.
patent: 5811388 (1998-09-01), Friend et al.
patent: 5811395 (1998-09-01), Schwabe et al.
Guller, S., et al., “Negative Regulation of Placental Fibronectin Expression by Glucocorticoids and Cyclic Adenosine 3′, 5′-Monophosphatea,b,” Annals New York Academy of Sciences, 734:132-142, (1994).
MacLennan, A.H., et al., “Ripening of the Human Cervix and Induction of Labor With Intracervial Purified Porcine Relaxin,” Obstetrics & Gynecology, 68(5):598-601, (1986).
Poisner, A.M., et al., “Relaxin Stiumulates the Synthesis and Release of Prorenin from Human Decidual Cells: Evidence for Autocrine/Paracrine Regulation,” Journal of Clinical Endocrinology and Metabolism, 70:(6):1765-1767, (1990).
Büllesbach, E.E., et al., “Total Synthesis of Human Relaxin and Human Relaxin Derivatives by Solid-phase Peptide Synthesis and Site-directed Chain Combination,” The Journal of Biological Chemistry, 266(17):10754-10761, (1991).
O'Day-Bowman, M.B., et al., “Hormonal Control of the Cervix in Pregnant Gilts. III. Relaxin's Influence on Cervical Biochemical Properties in Ovariectomized Hormone-Treated Pregnant Gilts,” Endocrinology, 129(4): 1967-1976, (1991).
Saugstad, L.F., “Persistent Pelvic Pain and Pelvic Joint Instability,” European Journal of Obstetrics & Gynecology and Reproductive Biology, 41:197-201, (1991).
Büllesbach, E.E., et al., “The Receptor-binding Site of Human Relaxin II,” The Journal of Biological Chemistry, 267(32):22957-22960, (1992).
Hall, J.A., et al., “Influence of Ovarian Steroids on Relaxin-Induced Uterine Growth in Ovariectomized Gilts,” Endocrinology, 130(6):3159-3166, (1992).
Kibblewhite, D., et al., “The Effect of Relaxin on Tissue Expansion,” Arch Otolaryngol Head Neck Surgery, 118:153-156, (1992).
Lee, A.B., et al., “Monoclonal Antibodies Specific for Rat Relaxin. VI. Passive Immunization with Monoclonal Antibodies throughout the Second Half of Pregnancy Disrupts Histological Changes Associated with Cervical Softening at Parturition in Rats,” Endocrinology, 130(4):2386-2391, (1992).
Bell, R.J., et al., “A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety of Vaginal Recombinant Human Relaxin for Cervical Ripening,” Obstetrics & Gynecology, 82(3):328-333, (1993).
Bryant-Greenwood, G.D., et al., “Sequential Appearance of Relaxin, Prolactin and IGFBP-1 During Growth and Differentiation of the Human Endometrium,” Molecular and Cellular Endocrinology, 95:23-29, (1993).
Chen, S.A., et al., “The Pharmacokinetics of Recombinant Human Relaxin in Nonpregnant Women After Intravenous, Intravaginal, and Intracervical Administration,” Pharmaceutical Research, 10(6):834-838, (1993).
Huang, C., et al., “Stimulation of Collagen Secretion by Relaxin and Effect of Oestrogen on Relaxin Binding in Uterine Cervical Cells of Pigs,” Journal of Reproduction and Fertility, 98;153-158, (1993).
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Davenport Avis M.
Fredrikson & Byron , P.A.
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