Coramsine (SBP002) was an experimental cancer drug that was evaluated in preliminary clinical trials, but was abandoned by Solbec Pharmaceuticals Ltd after the results were insufficient for them to raise investment capital to continue its

development Development or developing may refer to: Arts *Development (music), the process by which thematic material is reshaped * Photographic development *Filmmaking, development phase, including finance and budgeting * Development hell, when a proje ...

Composition

Coramsine is a

chemotherapeutic Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) in a standard regimen. Chemotherapy may be given with a curat ...

and immunomodulating agent whose primary ingredients are two

solasodine Solasodine is a poisonous alkaloid chemical compound that occurs in plants of the family Solanaceae such as potatoes and tomatoes. Solasonine and solamargine are glycoalkaloid derivatives of solasodine. Solasodine is teratogenic to hamster fe ...

glycoalkaloid Glycoalkaloids are a family of chemical compounds derived from alkaloids to which sugar groups are appended. Several are potentially toxic, most notably the poisons commonly found in the plant species '' Solanum dulcamara'' (bittersweet nightshad ...

solasonine Solasonine is a glycoalkaloid that is found in ''Solanum'' plants of the family Solanaceae. Solasonine is a poisonous chemical compound when used at high levels. It is a glycoside of solasodine. Glycoalkaloids such as solasonine have various appl ...

and

solamargine Solamargine is a cytotoxic chemical compound that occurs in plants of the family Solanaceae, such as potatoes, tomatoes, and eggplants. It has been also isolated from ''Solanum nigrum'' fungal endophyte ''Aspergillus flavus''. It is a glycoalkaloi ...

, which are derived from the plant ''

Solanum linnaeanum ''Solanum linnaeanum'' is a nightshade species known as devil's apple and, in some places where it is introduced, apple of Sodom. The latter name is also used for other nightshades and entirely different plants elsewhere, in particular the poiso ...

'' (devil's apple).

History

The study of glycoalkaloids as potential anti-cancer agents began with

Queensland Queensland ( , commonly abbreviated as Qld) is a States and territories of Australia, state in northeastern Australia, and is the second-largest and third-most populous state in Australia. It is bordered by the Northern Territory, South Austr ...

researcher Bill Cham in the late 1970s. Cham heard 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'' (meaning ''in glass'', or ''in the glass'') Research, studies are performed with Cell (biology), cells or biological molecules outside their normal biological context. Colloquially called "test-tube experiments", these studies in ...

'' studies 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 is the most dangerous type of skin cancer; it develops from the melanin-producing cells known as melanocytes. It typically occurs in the skin, but may rarely occur in the mouth, intestines, or eye (uveal melanoma). In very rare case ...

skin cancer Skin cancers are cancers that arise from the Human skin, skin. They are due to the development of abnormal cells (biology), cells that have the ability to invade or metastasis, spread to other parts of the body. It occurs when skin cells grow ...

.Solbec Pharmaceuticals
Retrieved on 15 October 2008. In 2000, Solbec Pharmaceuticals Ltd. licensed the intellectual property rights to BEC from Cham and after it displayed good results against

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 provides a lubricating fluid to enable the organs to move and work ...

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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

in the treatment of

renal cell carcinoma Renal cell carcinoma (RCC) is a kidney cancer that originates in the lining of the Proximal tubule, proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. RCC is the most common type of kidney cance ...

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 The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertisi ...

(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 coramsine further, abandoning its development, as they changed the company's direction as well as its legal business name in December 2008, following the

Great Recession The Great Recession was a period of market decline in economies around the world that occurred from late 2007 to mid-2009.

and

credit crunch A credit crunch (a credit squeeze, credit tightening or credit crisis) is a sudden reduction in the general availability of loans (or credit) or a sudden tightening of the conditions required to obtain a loan from banks. A credit crunch generally ...

. The subsequent company licensed the technology back to the original founder, Bill Cham, who manufactures it from his private company in

Vanuatu Vanuatu ( or ; ), officially the Republic of Vanuatu (; ), is an island country in Melanesia located in the South Pacific Ocean. The archipelago, which is of volcanic origin, is east of northern Australia, northeast of New Caledonia, east o ...

and markets it worldwide via the internet under the name Curaderm BEC5, a cream of solasodine rhamnosyl glycosides (BEC). Curaderm BEC5 has not been approved for medical use by any regulatory agency.

Mechanism of action

Cormasine is thought to kill tumor cells by direct cell

lysis Lysis ( ; from Greek 'loosening') is the breaking down of the membrane of a cell, often by viral, enzymic, or osmotic (that is, "lytic" ) mechanisms that compromise its integrity. A fluid containing the contents of lysed cells is called a ...

, showing selectivity for cancer cells as opposed to healthy cells via a

rhamnose Rhamnose (Rha, Rham) is a naturally occurring deoxy sugar. It can be classified as either a methyl- pentose or a 6-deoxy- hexose. Rhamnose predominantly occurs in nature in its L-form as L-rhamnose (6-deoxy-L- mannose). This is unusual, since mo ...

binding protein. Coramsine also has the potential to modulate the production of

interleukin-6 Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. In humans, it is encoded by the ''IL6'' gene. In addition, osteoblasts secrete IL-6 to stimulate osteoclast formation. Smoo ...

References

{{Reflist, 2 Alkaloids Abandoned drugs