Evgen Pharma's Sulforadex has successfully completed Phase I clinical development

6th June 2014

Evgen Pharma can announce that Sulforadex has successfully completed Phase I clinical development. The completion of the multiple-ascending dose (MAD) trial in healthy human volunteers follows the successful single-ascending dose trial that completed last year. The trials have established the dosing limits and have delivered excellent oral pharmacokinetics with no unexpected or serious adverse effects. 

Evgen Pharma is now preparing to initiate a number of patient trials in the UK and US. These include clinical trials in breast cancer, prostate cancer, Acute Lymphoblastic Leukaemia (ALL) and Subarachnoid Haemorrhage (SAH). Sulforadex has also recently produced compelling preclinical efficacy data in animal models for osteoarthritis and COPD. 

Whilst the market, and current drug pipeline, for advanced prostate cancer is extremely competitive, Evgen is initially targeting patients diagnosed with early-stage indolent prostate cancer that elect active surveillance. There are currently no approved drugs for this large population of men, representing approximately 30% of all diagnoses. 

In the breast cancer field, Sulforadex® has recently been demonstrated by Evgen Pharma to be a potent agent against breast cancer stem cells derived from patients. Cancer stem cells are believed to be a major factor behind the recurrence of many cancers and are thus targets of major interest to large biotechnology and pharmaceutical companies. 

Commenting on the completion of the Phase I clinical development, Evgen Pharma Chief Executive Dr Stephen Franklin said:

'It is a strong testament to our business model, and the experience of the team, that we have completed Phase I development so efficiently. We now aim to advance Sulforadex into proof-of-concept patient trials and we head into those in the unusual position of having an unprecedented amount of published data on regular sulforaphane, which in its native form is not a viable pharmaceutical product. The compelling nature of the published science, together with our own data on Sulforadex (the stable form of this molecule) leads us to believe that the probability of success in the clinic is atypically high.'