Atossa Hits Enrolment Milestones In Three Phase 2 Trials Of Endoxifen In Breast Cancer

(RTTNews) - Atossa Therapeutics, Inc. (ATOS) said on Monday that it has achieved major enrollment milestones in three ongoing Phase 2 clinical trials for its drug candidate (Z) Endoxifen.

The lead drug candidate is a proprietary oral formulation of (Z)-endoxifen, which is being developed for breast cancer.

Atossa is evaluating (Z)-endoxifen in three Phase 2 studies, dubbed EVANGELINE, Karisma-Endoxifen, and I-SPY trial.

EVANGELINE is a phase II randomized non-inferiority trial of (Z)-endoxifen, and exemestane plus goserelin as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Enrollment in the pharmacokinetic (PK) run-in cohort, of the EVANGELINE trial was completed in June of this year. The PK run-in cohort consists of six patients.

Karisma-Endoxifen is a phase II study investigating (Z)-endoxifen in premenopausal women with measurable breast density. The study is 70% enrolled and is expected to be fully enrolled by year-end 2023. Data from this study is anticipated in 2024.

In the study arm of the phase II I-SPY trial, (Z)-endoxifen is being evaluated as a neoadjuvant treatment in patients with newly diagnosed estrogen receptor-positive invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. About 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery. This study is 30% enrolled.

The pipeline update was provided by the company when reporting second-quarter financial results today.

For the second-quarter, Atossa has posted a net loss of $9.830 million or $0.08 per share, compared with $6.672 million or $0.05 per share in loss, registered for the same period of last year.