Pre-menopausal women with breast cancer will receive the neoadjuvant treatment for up to six months, followed by surgery. Credit: EM Karuna/Shutterstock.com.

Atossa Therapeutics has received approval from Health Canada to initiate the Phase II Endoxifen Versus exemestANe GosEreLIn (EVANGELINE) study in pre-menopausal women with breast cancer.

With the ‘No Objection Letter’ from Health Canada, the company will enrol patients throughout Canada and open sites to conduct the study.

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The ongoing, non-inferiority, randomised study intends to assess Atossa’s (Z)-endoxifen, a patented selective estrogen receptor modulator (SERM), along with exemestane and goserelin.

Pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer are randomised to receive the combined therapy as a neoadjuvant treatment.

They will receive the treatment for up to six months, followed by surgery.

Evaluating the endocrine-sensitive disease rate, as measured by Ki-67, after treatment for four weeks with (Z)-endoxifen against exemestane plus goserelin is the primary objective of the study.

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The study intends to enrol nearly 175 patients across Canada and the US.

Atossa president and CEO Dr Steven Quay said: “The authorisation of our Clinical Trial Application in Canada will increase the geographic scope of our enrolment efforts for EVANGELINE and broaden the network of breast cancer specialists familiar with (Z)-endoxifen in the neoadjuvant setting.

“In the coming weeks, we will have data from the pharmacokinetic run-in cohort, which is designed to identify the optimal dose for the treatment arm.

“Once the dose is confirmed, we expect the pace of enrolment to increase as we activate additional sites in the US and Canada.”