Evgen Pharma’s anti-stress drug SFX-01, which is currently in its Phase II study has shown good results and it can proceed as planned.
Independent Data Safety Monitoring Board (DSMB) reviewed the product as the twentieth patient was for a minimum of seven days whilst in hospital care. The trial can now proceed as planned, allowing continuation of dosing after discharge from hospital and up to 28 days.
The cancer focused drugmaker and nerve specialist Evgen Pharma received orphan drug designation from the US Food & Drug Administration in August 2016 for the use of stabilised sulforaphane for the treatment of SAH, a rare form of stroke. Orphan designation gives anti-cancer agent and neuro-protective SFX-01 the potential for US market exclusivity for seven years from the date of marketing approval.
SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.
Dr Stephen Franklin, CEO of Evgen Pharma, said: “We are delighted that the DSMB has given a favourable review of our Phase II study of SFX-01 in subarachnoid haemorrhage, a rare but devastating condition with high unmet clinical need. This is the first safety review of SFX-01 in a patient cohort and as such represents an important milestone in the clinical development of SFX-01.”