Evgen Pharma receives approval for breast cancer study

The AIM-traded firm said patient recruitment will begin in the UK at Manchester's Christie NHS Foundation Trust following Research Ethics approval, which is expected during the coming weeks.

Further regulatory and Research Ethics approvals are also expected shortly at various sites across Europe for the multi-centre study, the board reported.

It said the STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial will investigate SFX-01 in combination with different hormone-based therapies in 60 metastatic breast cancer patients whose cancer cells are estrogen-receptor positive (ER+).

The primary objectives of the STEM trial are to evaluate safety and efficacy via tumour imaging in patients starting to become resistant to mainstream hormone therapy.

Patients will be enrolled into one of three study arms - SFX-01 in combination with either aromatase inhibitors, tamoxifen or fulvestrant - based on their current therapy.

It will be led by chief investigator Dr Sacha Howell at Manchester's Christie NHS Foundation Trust, Europe's largest single-site cancer centre, and include several other sites across Europe.

The company says first patient is expected to be recruited in October 2016.

“Many therapies used in cancer ultimately fail as patients develop resistance - one hypothesis is that this resistance is driven by cancer stem cells which, unlike a mature cancer cell, do not respond to current standards of care,” said Evgen CEO Dr Stephen Franklin.

“Our excitement with SFX-01 is that it targets the cancer stem cell population and therefore has the potential to improve the efficacy and longevity of a range of drugs used in cancer therapy - both approved drugs and those in clinical development.”