Evgen Pharma plc (LON:EVG), the clinical stage drug development company focused on cancer and neurological conditions, announces its unaudited interim results for the six months ended 30 September 2016.
Highlights in the year to date:
· First patient dosed (April 2016) in the Company’s Phase II clinical trial SAS (SFX-01 after subarachnoid haemorrhage) and patient recruitment rates in-line with expectations
· US Food & Drug Administration (“FDA”) granted the Company orphan drug designation (August 2016) for the use of stabilised sulforaphane in subarachnoid haemorrhage (“SAH”)
· First clinical site is now open for patient recruitment for the Company’s Phase II clinical trial STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer), with further sites due to open across Europe in H1 CY 2017
· Further preclinical data to be presented at the San Antonio Breast Cancer Symposium (December 2016) entitled SFX-01 targets Wnt signalling to inhibit stem-like cells in breast cancer patient-derived xenograft tumours
· Positive data from preclinical studies of SFX-01 in various models of the relapsing remitting form of multiple sclerosis (“MS”) presented (September 2016) at leading MS conference
· Dr Bob Holland and Dr Tom Morris appointed as Medical Advisers, in neurology and oncology respectively (September 2016)
· The total comprehensive loss for the period was £1.7m (30 September 2015: total comprehensive loss £1.2m)
· The cash position (including short-term deposits) at 30 September 2016 was £5.5m (30 September 2015: £1.8m); the IPO placing in October 2015 raised £7.0m (gross), fully funding the Company to complete two Phase II studies and to support further preclinical work
Stephen Franklin, Chief Executive Officer of Evgen Pharma plc, said: “We are pleased with the significant progress made this year. The SAS trial is recruiting patients as planned and the STEM trial has now opened for recruitment at the first site in Europe. Both trials are projected to report in-line with expectations in the first half of calendar year 2018. Furthermore, we have secured orphan designation for our lead product in the treatment of subarachnoid haemorrhage, a type of stroke for which there has been no material advance in treatment for over 20 years.
“In addition to the clinical programmes, we were delighted to present positive preclinical data for SFX-01 at this year’s ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis), the largest annual conference dedicated to basic and clinical research in MS. The data demonstrated that SFX-01 was superior to the active principle in Biogen’s Tecfidera®, particularly in the way that it improved neurological recovery in the chronic stage after relapse. As part of an ongoing strategic review, the Company continues to assess all options for a potential third clinical programme.”