Atossa’s Phase II trial aims to study the therapy as a treatment for pre-menopausal women with ER+/HER2 breast cancer. Credit: Angiola Harry / Unsplash.

US-based biopharmaceutical firm Atossa Therapeutics has finished enrolling a pharmacokinetic (PK) run-in cohort in its Phase II trial of (Z)-endoxifen and exemestane with goserelin.

The EVANGELINE trial is measuring the combination therapy’s efficacy as a neoadjuvant treatment for breast cancer.

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The study will evaluate the therapy in pre-menopausal women with Grade I or II Oestrogen Receptor positive (ER+) or Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.

The PK run-in cohort includes six patients, who will each receive 40mg of (Z)-endoxifen a day for four weeks.

This cohort aims to find out whether the 40mg dose provides steady-state plasma concentrations (Css) of between 500ng/ml and 1000ng/ml and if these can target PKCβ1 inhibition and improve the antitumor activity of (Z)-endoxifen.

Once the optimal dose of (Z)-endoxifen has been determined, Atossa will begin the treatment cohort.

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In the treatment cohort, patients will be given neoadjuvant treatment for up to six months followed by surgery.

The EVANGELINE trial’s primary objective is to examine the endocrine sensitive disease (ESD) rate as calculated by Ki-67 after four weeks of treatment with (Z)-endoxifen versus the existing standard of care treatment, exemestane plus goserelin.

Atossa Therapeutics president and CEO Dr Steven Quay said: “We are excited to fully enrol the EVANGELINE PK run-in cohort and look forward to seeing data in Q3 of this year.

“The data will show us if the 40mg dose delivers the steady-state plasma concentrations required to effectively target PKCβ1 inhibition and enhance (Z)-endoxifen’s antitumor mechanism of action, or if we need to further optimise the dose.

“Identifying the optimal dose is an important milestone as it will allow us to activate additional sites in the US and advance plans to open sites outside of the US, which will increase the speed of recruitment for the EVANGELINE treatment cohort.”