Northland Capital partners view of Evgen Pharma plc LON:EVG: In line with our expectations, Evgen has received regulatory approval to commence its second Phase 2 trial, a study that will examine the effect of adding SFX-01 to commonly used breast cancer therapies. The company has demonstrated that in mouse models SFX-01 decreases breast cancer stem cell populations. This evidence, supported by a large body of academic research demonstrating the active ingredient’s effects against cancer stem cells, suggest that SFX-01 may have a therapeutic role in treating the disease. With two Phase 2 trials now underway, and with both trials fully funded, Evgen is well positioned to deliver significant value creation.
| Evgen Pharma plc (EVG.L) – BUY*: Clinical trial approval |
| Market Cap: £18m; Current Price: 25p; Target Price: 79p |
| Approval for Phase 2 breast cancer study |
| n Evgen Pharma announced that it has received a Clinical Trial Approval (CTA) from the UK’s regulatory agency for the commencement of its Phase II clinical trial of SFX-01 in breast cancer.
n 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. n Further regulatory and Research Ethics approvals are also expected shortly at various sites across Europe in this multi-centre study. n 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+). n The primary objectives of the STEM trial are to evaluate safety and efficacy in patients starting to become resistant to mainstream hormone therapy. n 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. n The first patient is expected to be recruited in October 2016. |
