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 hell, when a project is stuck in development *Filmmaking, development phase, including finance and budgeting *Development (music), the process thematic material is reshaped * Photograph ...

Composition

Coramsine is a

chemotherapeutic Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs ( chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemothera ...

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 fetus ...

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 nightshade) ...

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 Solasodine is a poisonous alkaloid chemical compound ...

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 glycoalk ...

, 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 po ...

'' (Devil's Apple).

History

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

Queensland ) , nickname = Sunshine State , image_map = Queensland in Australia.svg , map_caption = Location of Queensland in Australia , subdivision_type = Country , subdivision_name = Australia , established_title = Before federation , establishe ...

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'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called " test-tube experiments", these studies in biology ...

'' 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

skin cancer Skin cancers are cancers that arise from the skin. They are due to the development of abnormal cells that have the ability to invade or spread to other parts of the body. There are three main types of skin cancers: basal-cell skin cancer (BCC) ...

.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 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 and Aged Care, the TGA regulates the quality, supply and advertising of medicines, p ...

(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 US investment market's late-2008 turmoil and ensuing

credit crunch A credit crunch (also known as 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 cr ...

. 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 (french: link=no, République de Vanuatu; bi, Ripablik blong Vanuatu), is an island country located in the South Pacific Ocean. The archipelago, which is of volcanic origin, is east of no ...

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