SomaDex is a medication candidate based on an endogenous hormone, somatostatin, with a range of effects on humans. One effect is that it acts as a natural “cut(turn)-off hormone”, i.e. it can cut(turn) off secretion of growth factors, proteins that stimulate growth, and various hormones such as the growth hormone in the event of acromegalia. Several tumour types express somatostatin receptors, recipient proteins for somatostatin, including certain types of pituitary gland tumours, neuroendocrine tumours and prostate cancer.
Natural somatostatin is unstable and breaks down quickly in the body, which means that it has very limited clinical applications. Synthetic somatostatin analogues are well-established medications for the treatment of neuroendocrine tumours and acromegalia (Sandostatin®, Novartis). Using the company’s technical platform, natural somatostatin has been stabilised, SomaDex, which gives a half-life of approx. 37 hours compared with approx. 3 minutes for natural somatostatin. Extended half-life along with somatostatin’s biological properties give SomaDex extensive clinical applications. SomaDex is intended for the treatment of acromegalia (abnormal bodily growth), neuroendocrine tumours (a type of hormone producing tumours) and palliative (symptom-relieving) treatment of CRPC.
Preclinical development took place between 1997-2000 and in 2003, a clinical phase I study was concluded in Helsinki. A clinical phase II/pilot study was conducted between 2006-2009 on CRPC patients using SomaDex as monotherapy in Mexico. The result of the study showed good symptom-relieving effect (regarding skeletal-related pain) and enhanced quality of life. Only a few and mild side effects are deemed to be associated with the treatment.
After completion of the pilot study, SomaDex was licensed to the Mexican medical company Techsphere Corp in 2009. DexTech withdrew the license for SomaDex in 2012. The company is now seeking a new licensee/development partner for SomaDex.