Evgen Pharma upbeat on latest news from SFX-01 studies
Evgen Pharma
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16:55 22/04/24
Clinical stage drug development company Evgen Pharma announced on Monday that five patients who participated in the ‘STEM’ trial received ‘SFX-01’ treatment for more than one year, with two of those patients continuing to be treated with SFX-01.
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The AIM-traded firm said that for those 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 had now reached 438 days of dosing, and the other 476 days, with the latter exceeding the previous best of 448 days.
Evgen explained that all patients entering STEM had ER+ metastatic, or stage four, breast cancer and had confirmed progressive disease at the point of entry into the study, meaning their tumours had grown at least 20% since their last scan.
As a result, they were considered to have 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 such an advanced stage of disease, to elicit a clinical benefit by halting growth or shrinking the tumours.
As it announced on 25 March, 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 board said the news of such a sustained response to SFX-01 was being welcomed “days” before it was due to present the STEM results via a scientific poster at the European Society for Medical Oncology in Barcelona.
“We are delighted that these patients continue to benefit from SFX-01 after their participation in the STEM trial,” said Evgen Pharma chief executive officer Steve Franklin.
“This patient group has failed on all previous therapies and have very few options remaining.”
Franklin said the company could not have expected to see such an enduring benefit in late stage disease, and so it was continuing to plan the on-going development of SFX-01 in ER+ metastatic breast cancer with elevated confidence - targeting the earlier stages of the disease before resistance to all endocrine therapies was 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.”