Evgen Pharma confirms positive results from latest 'SFX-01' trial

Clinical stage drug development company Evgen Pharma announced positive headline results from the open-label phase 2 trial of ‘SFX-01’ in 46 patients with estrogen-positive metastatic breast cancer on Monday.

The AIM-traded firm said the study showed “conclusive evidence” of anti-cancer activity via objective responses, or tumour shrinkage.

It reported that 24% of patients showed a “durable clinical benefit” for at least six months, despite the late stage of disease and patients' established resistance to hormone therapy.

The study also showed a “mild and favourable” side effect profile for an anti-cancer drug.

Further development of SFX-01 was planned for earlier stage patients, as an adjunct to a second-line hormone therapy to delay the onset of resistance.

“We are very excited by the STEM trial results,” said chief investigator at Manchester’s Christie Hospital, Dr Sacha Howell.

“This level of disease stabilisation, coupled with objective evidence of tumour shrinkage, bodes well for testing SFX-01 earlier in the treatment path.

“It would not be unreasonable to expect to see even greater efficacy when SFX-01 is given alongside a hormone therapy to which the cancer is naïve, with the intention of delaying the onset of hormone resistance.”

Dr Howell said the clinical need associated with improving the durability of response to hormone therapies was evidenced by recent commercial success of CDK4/6 inhibitors.

“However, metastatic breast cancer remains incurable and despite the initial success with these drugs all cancers will progress and patients require additional active therapies.

“If clinical development continues positively, we can foresee SFX-01 being used with second line hormone therapy after CDK4/6 inhibitors' failure,” Dr Howell explained.

“The excellent tolerability of SFX-01 makes this a very attractive proposition.”

Dr Stephen Franklin, chief executive of Evgen Pharma, said the company was “absolutely delighted” with the trial result, explaining that it had “galvanised” its enthusiasm and commitment to ensure SFX-01 continued 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,” Dr Franklin said.

“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.

“We now look forward to submitting the data to the 2019 ESMO Congress in Barcelona, a key event in terms of disseminating the results to the clinical community and supporting our ongoing business development activity.”