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SFX-01 meets primary endpoints in STEM trial
SFX-01 meets primary endpoints in STEM trial.
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[{"type":"text","content":"\n \nRNS Number : 8076T Evgen Pharma PLC 25 March 2019 \n\n \n\n\n\n\nFor immediate release\n\n\n25 March 2019\n\n\n\n\n \n \n \n \n \nEvgen Pharma plc\n(\"Evgen\" or \"the Company\")\n \nSFX-01 meets primary endpoints in Phase II STEM trial\nfor the treatment of metastatic breast cancer\n \nEvgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, today announces positive headline results from the open-label Phase II trial of SFX-01 in 46 patients with estrogen-positive (ER+) metastatic breast cancer. \n \nHighlights\n \n· Conclusive evidence of anti-cancer activity via objective responses (tumour shrinkage)\n \n· 24% of patients show a durable clinical benefit for at least 6 months, despite the late stage of disease and patients' established resistance to hormone therapy\n \n· Mild and favourable side effect profile for an anti-cancer drug\n \n· Further development of SFX-01 planned for earlier stage patients as an adjunct to a second line hormone therapy to delay onset of resistance\n \nThe STEM trial's Chief Investigator, Dr Sacha Howell of the Christie Hospital, will discuss the headline results today at 9am GMT via a live webcast and simultaneous conference call. Further details are set out below.\n \nThe STEM trial is the first study of SFX-01 in cancer patients and had the objectives of evaluating the safety and tolerability of SFX-01 in combination with an aromatase inhibitor (AI) or tamoxifen or fulvestrant; and of determining the clinical benefit rate (\"CBR\") at 24 weeks.\nWith regards to safety and tolerability, the primary endpoint was the number and severity of treatment-emergent adverse events (side effects). As expected, SFX-01 had a favourable side effect profile, particularly when compared with other drugs used in cancer therapy. The main side effects were mild (Grade 1) gastrointestinal symptoms, including nausea and reflux. \nWith regards to efficacy, the primary endpoint was CBR at 24 weeks - the percentage of patients that had an objective response (tumour shrinkage by at least 30%) or stable disease for at least 24 weeks. CBR is a standard tool for assessing drug activity ...