Coramsine
Encyclopedia
Coramsine or Coramsine/SBP002 is a chemotherapeutic and immunomodulating
agent whose primary ingredients are two solasodine glycoalkaloid
s, solasonine and solamargine, derived from Solanum linnaeanum
(Devil's Apple).
The use of glycoalkaloids as anti-cancer agents was discovered by Queensland
researcher Dr. Bill Cham in the late 1970s after hearing reports from farmers that topical application of the Devil's Apple plant was effective in slowing the growth of various skin cancers on horses and cattle.
Animal studies and in vitro
human trials showed positive results, however Cham decided to focus his energies on developing the glycoalkaloid mixture, patented as BEC, as a topical cream for non-melanoma
skin cancer
.
In 2000 Solbec Pharmaceuticals Ltd. licensed BEC's intellectual property rights from Dr. Cham and after displaying good results against peritoneal mesothelioma
in animals Solbec initiated human trials which also yielded encouraging results. Other researchers have also demonstrated antiproliferative activity of steroidal glycosides against cancer cells.
During 2005 and 2006 Solbec was granted orphan drug designation for Coramsine by the U.S. Food and Drug Administration in the treatment of renal cell carcinoma
and for malignant melanoma respectively. 2006 also saw the completion of Phase I/IIa trials and the commissioning of Phase IIb trials that would target renal cell carcinoma (stage III/IV) and malignant melanoma (stage III/IV), but in November 2006 shortly before their commencement Solbec postponed the trials due to Australia's Therapeutic Goods Administration
(TGA) having concerns about the drug's pre-clinical data. A development plan for Coramsine was approved by the TGA in May 2007 resulting in further pre-clinical studies, which were successfully completed in March 2008. Solbec unsuccessfully sought a business partner to develop Corasmine further but changed business name and direction in December 2008 and subsequent company licensed the technology back to the original founder.
Cormasine is thought to kill tumor cells by direct cell lysis
, showing selectivity for cancer cells as opposed to healthy cells via a patented rhamnose
binding protein. Coramsine also has the potential to modulate the production of Interleukin-6.
Immunomodulator
An immunomodulator, also known as an immunotherapy is a substance which has an effect on the immune system.- Immunosuppressants :Inhibits immune response in organ transplantation and autoimmune diseases.- Immunostimulants :...
agent whose primary ingredients are two solasodine glycoalkaloid
Glycoalkaloid
Glycoalkaloids are a family of poisons commonly found in the plant species Solanum dulcamara . There are several glycoalkaloids that are potentially toxic. A prototypical glycoalkaloid is called solanine , which is found in potato...
s, solasonine and solamargine, derived from Solanum linnaeanum
Solanum linnaeanum
Solanum linnaeanum is a nightshade species known as Devil's Apple and in some places where it is introduced as "Apple of Sodom"...
(Devil's Apple).
The use of glycoalkaloids as anti-cancer agents was discovered by Queensland
Queensland
Queensland is a state of Australia, occupying the north-eastern section of the mainland continent. It is bordered by the Northern Territory, South Australia and New South Wales to the west, south-west and south respectively. To the east, Queensland is bordered by the Coral Sea and Pacific Ocean...
researcher Dr. Bill Cham in the late 1970s after hearing reports from farmers that topical application of the Devil's Apple plant was effective in slowing the growth of various skin cancers on horses and cattle.
Animal studies and in vitro
In vitro
In vitro refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments...
human trials showed positive results, however Cham decided to focus his energies on developing the glycoalkaloid mixture, patented as BEC, as a topical cream for non-melanoma
Melanoma
Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye...
skin cancer
Skin cancer
Skin neoplasms are skin growths with differing causes and varying degrees of malignancy. The three most common malignant skin cancers are basal cell cancer, squamous cell cancer, and melanoma, each of which is named after the type of skin cell from which it arises...
.
In 2000 Solbec Pharmaceuticals Ltd. licensed BEC's intellectual property rights from Dr. Cham and after displaying good results against peritoneal mesothelioma
Peritoneal mesothelioma
Peritoneal mesothelioma is the name given to the cancer that attacks the lining of the abdomen. This type of cancer affects the lining that protects the contents of the abdomen and which also provides a lubricating fluid to enable the organs to move and work properly.The peritoneum is made of two...
in animals Solbec initiated human trials which also yielded encouraging results. Other researchers have also demonstrated antiproliferative activity of steroidal glycosides against cancer cells.
During 2005 and 2006 Solbec was granted orphan drug designation for Coramsine by the U.S. Food and Drug Administration in the treatment of renal cell carcinoma
Renal cell carcinoma
Renal cell carcinoma is a kidney cancer that originates in the lining of the proximal convoluted tubule, the very small tubes in the kidney that filter the blood and remove waste products. RCC is the most common type of kidney cancer in adults, responsible for approximately 80% of cases...
and for malignant melanoma respectively. 2006 also saw the completion of Phase I/IIa trials and the commissioning of Phase IIb trials that would target renal cell carcinoma (stage III/IV) and malignant melanoma (stage III/IV), but in November 2006 shortly before their commencement Solbec postponed the trials due to Australia's Therapeutic Goods Administration
Therapeutic Goods Administration
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
(TGA) having concerns about the drug's pre-clinical data. A development plan for Coramsine was approved by the TGA in May 2007 resulting in further pre-clinical studies, which were successfully completed in March 2008. Solbec unsuccessfully sought a business partner to develop Corasmine further but changed business name and direction in December 2008 and subsequent company licensed the technology back to the original founder.
Cormasine is thought to kill tumor cells by direct cell lysis
Lysis
Lysis refers to the breaking down of a cell, often by viral, enzymic, or osmotic mechanisms that compromise its integrity. A fluid containing the contents of lysed cells is called a "lysate"....
, showing selectivity for cancer cells as opposed to healthy cells via a patented rhamnose
Rhamnose
Rhamnose is a naturally occurring deoxy sugar. It can be classified as either a methyl-pentose or a 6-deoxy-hexose. Rhamnose occurs in nature in its L-form as L-rhamnose . This is unusual, since most of the naturally occurring sugars are in D-form...
binding protein. Coramsine also has the potential to modulate the production of Interleukin-6.