Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-08-13
2002-07-23
Goldberg, Jerome D. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S387000, C514S395000
Reexamination Certificate
active
06423734
ABSTRACT:
TECHNICAL FIELD
The present invention relates to methods of using one or more benzimidazole compounds and its pharmaceutically acceptable derivatives to treat and prevent cancer in both both human and warm blooded animals. In particular, this invention relates to benzimidazole and its derivatives in cancer prevention and maintenance therapy.
BACKGROUND OF THE INVENTION
Cancers are a leading cause of death in animals and humans. The exact cause of cancer is not known. There is evidence that certain activities such as smoking or exposure to carcinogens may enhance the risk for certain types of cancers and tumors.
Treatment of cancer in the early stages typically comprise local treatment such as, surgery and/or radiotherapy. While radiation therapy has been widely used in managing cancerous diseases, it is limited by lack or radiosensitivity of specific regions of malignant tumors. More advanced disease is treated by combining local treatment with chemotherapy. Although current chemotherapeutic agents have been shown to be effective against cancers and tumor cells, the use of combined treatment with all three regimens, surgery, radiotherapy, and chemotherapy, have not been shown to be effective against all cancer and tumor cells.
Much of the effort in therapeutics of cancer has focused on cancers that are metastasized. To date hormones, in particular estrogen, progesterone and testosterone, and some antibiotics produced by a variety of microbes, alkylating agents, and anti-metabolites form the bulk of therapies available to oncologists. Prostate cancer treatments, for example, rely on hormonal manipulation. However, in despite the initial high response rate, patients often develop hormone-refractory tumors. Unfortunately, the clinical usefulness of these treatments have been limited. This is because these therapies demonstrate only marginal levels of activity or generally unacceptable levels of cytotoxicity or both, thereby diminishing their usefulness in cancer treatment. Overall the results of cytotoxic chemotherapy have been disappointing indicating a long felt need for a new approach or treatment. Ideally cytotoxic agents that have specificity for cancer and tumor cells while not affecting normal cells would be extremely desirable. Unfortunately, none have been found and instead agents which target especially rapidly dividing cells (both tumor and normal) have been used.
SUMMARY OF THE INVENTION
A method of preventing cancer in a patient, especially colon cancer is disclosed. The patients are treated utilizing a benzimidazole compounds. its pharmaceutical addition salts, pharmaceutically acceptable derivatives or its prodrugs selected from the group having the formula:
wherein X is hydrogen, halogen, alkyl of less than 7 carbon atoms or alkoxy of less than 7 carbon atoms; n is a positive integer of less than 4; Y is hydrogen, chloro, oxychloro, nitro, methyl or ethyl; and R is hydrogen, or an alkyl group of from 1 to 8 carbon atoms and R
2
is NHCOOR
1
wherein R
1
is aliphatic hydrocarbon of less than 7 carbon atoms, and preferably an alkyl group of less than 7 carbon atoms is claimed.
Preferably the subjects are treated with compounds having the formula:
wherein R is an alkyl of 1 through 8 carbon atoms and R
2
is selected from the group consisting of NHCOOR
1
, wherein R
1
is methyl, ethyl or isopropyl and the non-toxic, pharmaceutically acceptable acid addition salts with both organic and inorganic acids. The most preferred compound is 2-methoxycarbonylamino-benzimidazole and its pharmaceutically acceptable salts.
Specifically, the invention provides a method of preventing various cancers associated with neoplasm or malignant tumors, for example, leukemia, sarcomas and lymphomas including prostate cancer, breast cancer, lung cancer, melanoma, and the like.
The present invention provides a method of treatment in a subject comprising administering a therapeutic amount of benzimidazole or a pharmaceutically acceptable derivative to humans or animals.
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Goldberg Jerome D.
Hersko Bart S.
The Procter & Gamble & Company
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