23rd Sep 2019 13:09
(Alliance News) - Evgen Pharma PLC said Monday two of the five patients entered into its extended stem clinical trial for metastatic breast cancer are still using the treatment.
Evgen said all five patients used the SFX-01 treatment for over one year, with all five reporting halt in 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.
The company said one patient has now reached 438 days of dosing and another on 476 days.
All five patients entering the trial had stage 4 metastatic breast cancer, with confirmed progressive tumour growth. As a result, the patients had become resistant to their previous 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," Evgen explained.
The trial met both its primary endpoints in March, with about 25% of patients seeing a clinical benefit during the six-month trial.
Patients that continued to have a benefit at six months were able to continue on SFX-01 in an extension phase.
"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," said Chief Executive Steve Franklin.
Franklin continued: "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," Franklin added.
Shares in Evgen Pharma were 2.3% higher in London on Monday at 16.50 pence each.
By Paul McGowan; [email protected]
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