25th Mar 2019 10:23
LONDON (Alliance News) - Evgen Pharma PLC on Monday announced positive headline results from its phase two Stem trial of SFX-01 in advanced breast cancer.
Shares in the clinical-stage drug developer were up 24% at 25.35 pence on Monday.
The trial of 46 patients with oestrogen-positive metastatic breast cancer found "conclusive evidence of anti-cancer activity", as seen in tumour shrinkage.
Oestrogen-positive breast cancers have receptors to the hormone oestrogen and can be treated through hormone therapy, but resistance to this therapy often develops over time.
Metastatic breast cancer is the most advanced stage of breast cancer, but despite this 24% of patients in the study showed durable clinical benefit - either by at least 30% tumour shrinkage or stable disease - for a minimum of six months.
Evegen described SFX-01's side effect profile in the study as "mild and favourable", particularly compared to other anti-cancer drugs.
Looking ahead, Evgen hopes to develop SFX-01 as a treatment for earlier stage patients who have only had one previous type of hormone therapy, to assess how well SFX-01 can delay resistance.
Evgen Pharma Chief Executive Stephen Franklin said: "We are absolutely delighted with the trial result and it has galvanised our enthusiasm and commitment to ensure SFX-01 continues its development in breast and other cancers. In the context of this particular patient group, the clinical benefit observed is very encouraging and we have a high level of confidence that it will perform even better when used to delay the resistance to a newly presented second-line hormone therapy.
"Apart from meeting the primary endpoints, we can also report that of the 46 patients in the trial, 13 registered for the compassionate use programme enabling access to the drug after completion of the study and the longest period for which a patient derived clinical benefit was an outstanding 448 days."
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