NEW YORK – Atossa Therapeutics on Thursday said that it will begin evaluating z-endoxifen as a neoadjuvant therapy for estrogen receptor-positive, HER2-negative breast cancer patients in Canada.
Health Canada has given the Seattle-based firm the go-ahead to enroll Canadian breast cancer patients to the Phase II EVANGELINE study, which Atossa launched in the US earlier this year.
In the trial, Atossa is randomizing 175 pre-menopausal patients with stage IIA or IIB breast cancer to receive either its investigational selective estrogen receptor modulator or a standard hormone therapy combination treatment of Pfizer's Aromasin (exemestane) plus TerSera Therapeutics' Zoladex (goserelin). Patients receive these drugs in the neoadjuvant setting prior to surgery.
Atossa's primary goal in the trial is to evaluate patients' endocrine-sensitive disease rate, which they are measuring using the biomarker Ki-67. The firm is also evaluating the drug's safety, pharmacokinetics, and optimal dose.