Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-11-20
2002-05-07
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06384044
ABSTRACT:
This invention relates to the treatment of cancer and is concerned more especially with treatment of cancer of the prostate gland in human males by administration of an essentially pure opiate receptor antagonist such as Naltrexone and Naloxone at a low level dosage.
SUMMARY OF RELATED DISCLOSURES USING ESSENTIALLY PURE OPIATE ANTAGONISTS
The use of an essentially pure opiate receptor antagonist in the treatment of several diseases has already been disclosed in patents in which I am named as an inventor. In U.S. Pat. No. 4,888,346, issued Dec. 19, 1989, the treatment was for the acquired immune deficiency syndrome (or AIDS) in any of its known states, including AIDS-related complex. In U.S. Pat. No. 5,013,739, issued May 7, 1991, the disease treated was chronic fatigue syndrome while in U.S. Pat. No. 5,346,900, issued Oct. 18, 1994, the disease was chronic herpes virus infections. In the latter patent, examples of treatment of multiple sclerosis and chronic inflammation of the connective tissue, such as arthritis and lupus, was also disclosed.
For the treatment of all these diseases, the amount of the essentially pure opiate receptor antagonist to be administered was required to be at a quite low level corresponding in results achieved thereby to those obtained by the administration of Naltrexone at a dosage level of from 1.0 mg. to 10 mg per day., preferably at a dosage level of 1.0 mg. to about 5 mg., and most preferably at about 3.0 mg per day. At dosage levels above about 10 mg per day, not only were the desired therapeutic results not obtained but the effect of the treatment appeared to be negative in exacerbating the disease.
In provisional application Ser. No. 60/108,838, filed Nov. 17, 1998, I disclosed that administration at a low dosage level of an essentially pure opiate receptor antagonist gives desirable therapeutic results in the treatment of a group of closely related malignancies known as lymphoproliferative syndrome, which includes malignant lymphoma, chronic lymphocytic leukemia, Hodgkin's disease (or Hodgkin's lymphoma), and non-Hodgkin's lymphoma. As the generic name suggests, these diseases are characterized by the multiplication or proliferation of tissue of the lymphatic system, especially lymphocytes (cells) produced in the lymph nodes. Lymphocytes are important components of the human immune response system and upon exposure to a foreign antigen in the human body naturally proliferate or multiply to combat the antigen. In this group of malignancies, the proliferation goes out of control, resulting in an abnormal level of lymphocytes in the blood stream, enlargement of the lymph nodes due to accumulation of the lymphocytes there, and other symptomatic characteristics. Administration of an essentially pure opiate receptor antagonist such as Naltrexone and Naloxone at a low level dosage appears by means of some up until now inexplicable mechanism to be useful in the treatment of this group of malignancies.
Finally, in provisional application Ser. No. 60/139,482, filed Jun. 17, 1999, I disclosed that administration at a low dosage level of an essentially pure opiate receptor antagonist gives desirable therapeutic results in the treatment of various cancers of the gastrointestinal tract including cancers of the esophagus, stomach, large and small intestines, rectum, pancreas and liver.
In addition to my prior disclosures identified above, the action of opiate receptor antagonists. exemplified by Naltrexone and Naloxone, when administered to a variety of living organisms, including tissue and cells, has been studied by Zagon et al in U.S. Pat. No. 4,689,332, among other patents and published papers. According to these studies, these antagonists can exert either a growth accelerating or a growth inhibiting effect dependent upon the length of time the opiate receptor sites of the organism are “completely and continuously” blocked or occupied by the antagonist. Specifically, a growth accelerating or promoting action occurs with blockage for a period of at least 12 hours per day, as can be achieved with a dosage of at least about 10 mg. and preferably about 20 mg. per day, whereas a growth inhibiting action occurs with blockage for only a period of about 2 to 12 hours per day, as can be achieved with a dosage of less than 10 mg. down to about 0.1 mg. per day.
The growth accelerating embodiment is said to be effective “to proliferation, migration, and differentiation of certain specific cells or tissue, including organ tissues, neural tissue, bone marrow, red blood cells, lymphocytes, liver cells, etc.” (See patent, col. 9, lines 15-25.) This disclosure, however, is silent as to whether these any of these same “cells or tissues” can be subject to the growth inhibiting embodiment, the focus of the inhibiting embodiment disclosure paralleling the above excerpt being on weight loss of the organism as a whole. (See col. 9, lines 32-45 and col. 10, lines 45-59.)
In addition, the growth inhibiting aspect is described as “related to the prevention, treatment and control of cancer” (see col. 10, line 60—col. 11, line 47), the essential disclosure in this connection being as follows: “The action of the compounds of the invention can be employed to terminate the rapid growth patterns of cancer and related abnormalities. It should be understood, that a regime of the present compounds cannot dissipate or reduce a tumor mass or other metastasized growth. These compounds can only terminate the growth of the abnormal cells and inhibit the continued growth thereof. However, by preventing tumor growth to continue [sic], i.e. reducing the tumor burden, the body's own defense mechanism, i.e. the immune system, has the opportunity to rid the body of the cancerous growth whether benign or malignant. This aspect of the invention is particularly significant in light of early diagnostic techniques which do reduce tumor size, or with procedures for tumor excision. Moreover, naloxone, naltrexone, or the other related compounds can be administered as a prophylaxis to human or animal subjects who may be exposed to potentially carcinogenic agents.”
The only cancer specifically identified in the patent for treatment by the Zagon etal concept is neuroblastoma in mice, which is illustrated by specific examples 2, 3, and 5, the only examples concerned with cancer. Neuroblastoma is a rather rare and special type of cancer, occurring in the sympathetic autonomous nervous system, i.e. mainly the nerves of the spinal column, and is essentially limited in occurrence to young children up to about 10 years of age. Evidence has been reported that neuroblastoma is peculiarly susceptible to natural immunobiological resistance. According to “IMMUNOBIOLOGY FOR THE CLINICIAN” by Barber, Copyright 1977, John Wiley & Sons, the lymphocytes of disease-free mothers of young neuroblastoma patients are able to kill neuroblastoma cells extracted from their diseased children but had no effect on normal tissue cells or tumor cells of other than neuroblastoma and lymphocytes of siblings of such patients also were able to kill neuroblastoma cells of the patients. (Cf p. 69). The same text states (at p. 102) that incidence of neuroblastoma nodules found by autopsy is “40-50 times greater” than the overall incidence of clinically diagnosed neuroblastoma. This obviously suggests that a competent immune system exerts a strong controlling action on neuroblastoma which is found in few if any other kinds of cancers.
While there is a tendency among the general public (and even the often equally uninformed media) to generalize among all “cancers”, (a conception which unfortunately appears to be shared by Zagon et al) “cancer” is, in fact, a collection of many distinct malignancies, each with its unique characteristics, behavior, and treatment response (which is one reason for the tortuously slow progress in the treatment of “cancer”), and this individualistic nature is especially applicable in the case of neuroblastoma. One cannot, therefore, reasonably extrapolate from the response of neuroblastom
Daniel William J.
Reamer James H.
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