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Evgen provides impressive update on extended-use phase of STEM trial

Evgen provides impressive update on extended-use phase of STEM trial

Evgen Pharma Plc recently updated the market with impressive data on its STEM trial. The regulatory announcement below provides further detail on the sustained response of SFX-01 in patients.

Evgen Pharma (AIM: EVG) a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces that five patients who participated in the STEM trial (“STEM”) received SFX-01 treatment for over one year, with two of these five patients continuing to be treated with SFX-01. For these five patients, SFX-01 halted their previously progressive tumour growth for the full six month period of the trial and for at least a further six months of extended use on compassionate grounds. Of the two patients continuing to be treated with SFX-01, one has now reached 438 days of dosing, and the other, 476 days; the latter exceeding the previous best of 448 days. 

All patients entering STEM had ER+ metastatic (Stage 4) breast cancer and had confirmed progressive disease at the point of entry into the study (i.e. their tumour(s) had grown more than 20% since their last scan) and thus become resistant to their current and all prior treatments. SFX-01 was then administered in addition to the current failing therapy to investigate whether it was possible, in this advanced stage of disease, to elicit a clinical benefit by halting growth or shrinking the tumours(s).

As announced on 25 March 2019, the trial met both primary endpoints with approximately 25% of patients demonstrating clinical benefit for the full six month duration of the trial. Patients that continued to have a benefit at six months were able to continue on SFX-01 in an extension phase.

The news of this sustained response to SFX-01, comes just days before the Company is due to present the STEM results via a scientific poster at ESMO (European Society for Medical Oncology) in Barcelona on 29 September. A link to the poster will be announced shortly after its presentation.

Steve Franklin, CEO of Evgen Pharma, commented: “We are delighted that these patients continue to benefit from SFX-01 after their participation in the STEM trial. This patient group has failed on all previous therapies and have very few options remaining. We could not have expected to see this kind of enduring benefit in such late stage disease and so we continue to plan with heightened confidence the on-going development of SFX-01 in ER+ metastatic breast cancer – targeting the earlier stages of the disease before resistance to all endocrine therapies is established. In this earlier part of the treatment path, one would expect SFX-01 to have even more impact where its role will be to significantly extend the utility of endocrine therapies without increasing the side effect burden.”