Treating neoplasms with neurotoxin

Abstract

The present invention provides a method of treating a cancer using a neurotoxin, preferably Botulinum toxin (“BTX”). The application of a neurotoxin around a cancer acts to decrease the contractile forces of the muscles surrounding a neoplasm which normally squeeze cancer cells through efferent channels leaving the cancer vicinity to distant sites. Also, the application of the toxin at sites distant from the cancer enhances cellular and humoral immunologic functions which further contributes to cancer cell death and spread. Following administration of botulinum toxin around and distant to a cancer, it is noticed that local, regional, and distant spread is reduced or eliminated. Immunomodulation with botulinum toxin is also valuable in treating other disease that may or may not be associated with cancers, such as viral-induced growths, viral conditions, fungal disease, chronic wounds, graft versus host disease, autoimmune disease, and HIV.

What is claimed is: 
     
         1 . A method of inhibiting the growth or metastasis of a neoplasm in a patient which comprises applying to the area around said neoplasm a therapeutically effective amount a pharmaceutically acceptable neurotoxin so that a substantial portion of the neurotoxin surrounds but does not penetrate the neoplasm. 
     
     
         2 . The method of  claim 1 , wherein the neoplasim is selected from the group consisting of digestive/intestinal, nervous system, heptobiliary, genitourinary, breast, respiratory, integament, musculoskeletal, hematopoietic, sensory organ, endocrine or neoendocrine neoplasms. 
     
     
         3 . The method of  claim 1 , wherein the neurotoxin is botulinum neurotoxin. 
     
     
         4 . The method of  claim 3 , wherein the neurotoxin is botulinum toxin type A neurotoxin. 
     
     
         5 . The method of  claim 1 , wherein the dose of neurotoxin does not exceed 500 units per application. 
     
     
         6 . The method of  claim 5 , wherein the dose of neurotoxin is between 0.01 and 100 units per application. 
     
     
         7 . The method of  claim 6 , wherein the dose of neurotoxin is between about 1 unit to about 50 units per application. 
     
     
         8 . The method of  claim 1 , wherein the neurotoxin is applied topically, by inhalation or by injection. 
     
     
         9 . The method of  claim 8 , wherein the neurotoxin is applied by injection. 
     
     
         10 . A method of inhibiting the growth or metastasis of a neoplasm in a patient which comprises injecting into the area of said neoplasm a therapeutically effective amount of botulinum toxin type A so that a substantial portion of the botulinum toxin type A surrounds but does not penetrate the neoplasm. 
     
     
         11 . The method of  claim 1 , further comprising injecting a therapeutically effective amount of a pharmaceutically acceptable neurotoxin into a regional or distal lymph node or nodes, regional or distal nodal tissue, thymus, spleen or bone marrow of the patient. 
     
     
         12 . The method of  claim 11 , wherein the neurotoxin is botulinum neurotoxin. 
     
     
         13 . The method of  claim 12 , wherein the neurotoxin is botulinum type A neurotoxin. 
     
     
         14 . The method of  claim 10 , further comprising injecting a therapeutically effective amount of botulinum toxin type A into a regional or distal lymph node or nodes, thymus, spleen or bone marrow of the patient. 
     
     
         15 . A method of treating a non-cancerous disease in a human characterized by reduced NK cell numbers, function or activity which comprises:
 a. applying to and around an area of tissue affected by said disease a therapeutically effective amount of a pharmaceutically acceptable neurotoxin;   b. applying a therapeutically effective amount of said neurotoxin to one or more lymph nodes which are proximate to said affected tissue; and   c. optionally applying a therapeutically effective amount of said neurotoxin to one or more lymph nodes which are distal to said affected tissue.   
     
     
         16 . The method of  claim 15 , further comprising injecting the neurotoxin into the spleen, the thymus or both the spleen and the thymus. 
     
     
         17 . The method of  claim 15  or  claim 16 , wherein the neurotoxin is botulinum toxin type A. 
     
     
         18 . The method of  claim 15 , wherein the disease is selected from the group consisting of viral infections, viral diseases, viral-induced growths, autoimmune disease, multiple sclerosis, chronic wounds, rheumatoid arthritis, myasthenia gravis, HIV, chronic fatigue syndrome and hepatitis. 
     
     
         19 . A method of treating a symptom of a neoplasm in a patient which comprises applying to the area around said neoplasm a therapeutically effective amount a pharmaceutically acceptable neurotoxin so that a substantial portion of the neurotoxin surrounds but does not penetrate the neoplasm.