Atossa Therapeutics Inc (NASDAQ:ATOS) has received what’s known as a no objection letter from Health Canada in response to its clinical trial application, the company announced.
This means the company is clear to begin enrolling patients and opening sites in Canada for its Phase 2 EVANGELINE study.of its patented breast cancer treatment.
Atossa has developed an oral formulation of a selective estrogen receptor modulator (SERM) called (Z)-Endoxifen designed to treat pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
An estimated 175 patients in Canada and the US will receive neoadjuvant treatment (ie, the first step to shrink a tumor) for six months, followed by surgery.
The goal of the study is to evaluate the endocrine sensitive disease (ESD) rate after four weeks of treatment compared to treatment with the current standard of care,
"The authorization of our clinical trial application in Canada will increase the geographic scope of our enrollment efforts for EVANGELINE and broaden the network of breast cancer specialists familiar with (Z)-endoxifen in the neoadjuvant setting,” CEO Steven Quay said in a statement.
"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 enrollment to increase as we activate additional sites in the United States and Canada.”
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