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Compassionate Use Programme and Trials Update
Compassionate Use Programme and Trials Update.
About this update from Theracryf Plc
[{"type":"text","content":"\n \nRNS Number : 7774G Evgen Pharma PLC 01 June 2017 \n\n \n\n\n\n\nFor immediate release\n\n\n 1 June 2017\n\n\n\n\n \n\n\n \n\n\n\n\nEvgen Pharma plc \n (\"Evgen Pharma\" or \"the Company\")\n \nInitiation of STEM Compassionate Use Programme\n and Clinical Trials Update\nEvgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, is pleased to announce an update on its two Phase II clinical trials.\nSTEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) is a multi-centre, Phase IIa clinical trial led by Principal Investigator Dr Sacha Howell of the Christie Hospital in Manchester, UK. The first patient was dosed in the study in January 2017.\nPrior to entry to the STEM trial, patients must have previously responded to their current hormone therapy for at least six months but then present with progressive disease, thereby demonstrating the start of resistance to the hormone therapy. Once entered into the trial, patients continue to receive their hormone therapy in addition to SFX-01 and have regular scans through to week 24. Patients discontinue the trial when one of the scans shows disease progression or at week 24. \nThe Company announces today that the first patient to enter the STEM trial is now approaching week 24, having demonstrated no disease progression for three consecutive scans. On this basis, the Company has initiated a compassionate use programme, so that patients can continue to receive SFX-01 after week 24.\nSTEM will recruit 60 patients from multiple sites in the UK and from sites in up to four other European countries. Two sites are currently open for recruitment (Manchester, UK, and Brussels, Belgium) and a total of nine patients have been enrolled so far. Due to protracted regulatory submissions in France, Spain and the Czech Republic, the Company is now projecting the final read-out from the study in the second half of calendar year 2018. The Company will issue an interim data analysis in the first half of calendar year 2018.\nThe primary endpoints of the STEM trial are safety, tolerability and clinical benefit rate (\"CBR\") as measured by RECIST (Response Evaluation Criteria In Solid Tumours). \nSAS (SFX-01 After Subarachnoi...