Atossa Therapeutics Inc (NASDAQ:ATOS), a company specializing in developing pharmaceuticals, has announced that a pre-menopausal breast cancer patient has completed a successful five-year treatment using its drug (Z)-endoxifen.
The Seattle-based company reported that the patient, diagnosed with Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer, remains cancer-free with no significant safety or tolerability issues reported throughout the treatment period.
The treatment involved administering (Z)-endoxifen both before and after surgery, known as neoadjuvant and adjuvant therapy respectively, and was conducted under the FDA’s expanded access program, which allows patients to access investigational drugs outside of clinical trials.
Dr. Steven Quay, Atossa's CEO, expressed optimism regarding the potential of (Z)-endoxifen to revolutionize breast cancer treatment, particularly for the 250,000 women diagnosed with ER+ breast cancer annually in the US.
Quay noted that the current standard of care, which often involves treatments associated with adverse effects, is “sub-optimal” as it requires ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women.
The patient, a 51-year-old premenopausal woman, initially presented with a moderately differentiated invasive ductal breast carcinoma, demonstrating favorable response indicators following neoadjuvant (Z)-endoxifen therapy. Notably, post-surgery, the patient continued adjuvant (Z)-endoxifen treatment, with no recurrence of breast cancer or adverse symptoms reported to date.
“She remains cancer-free today and we are grateful to have been able to help her with a difficult treatment problem,” Quay said in a statement.
Atossa’s success underscores the potential of (Z)-endoxifen as a viable treatment option, especially for patients with genetic factors limiting traditional therapies like tamoxifen. Under the FDA Expanded Access program, Atossa's (Z)-endoxifen remains restricted to this patient.
Atossa Therapeutics remains committed to advancing innovative medicines in oncology, with a focus on addressing significant unmet medical needs in breast cancer treatment.