Atossa Therapeutics Inc. (NASDAQ: ATOS) has announced that the Swedish Ethics Review Authority has given it the approval to commence Phase 2 oral Endoxifen clinical study for mammographic breast density (MBD) reduction.
MBD is an emerging public health concern
MBD is a growing public health concern affecting more than 10 million women in the US and many more globally. According to studies, MBD lowers the effectiveness of mammography to detect cancer and raises the chance of developing breast cancer. However, other studies have found a link between lowering MBD and reducing the risk of breast cancer.
CEO and Chairman Steven Quay said, “With this ethics approval and the previously reported regulatory approval to conduct the clinical study, we plan to start enrolling participants in fourth quarter 2021. We are excited to be working with Dr. Per Hall, a world leader in the field of breast density reduction, once again with our Endoxifen program.”
Per Hall, who is the head of the medical epidemiology and biostatistics department at Karolinska Institutet, will be the principal investigator of the study. The Karisma-Endoxifen research is a Phase 2 randomized, double-blind, placebo-controlled dose-response study in healthy premenopausal women with enhanced breast density using Atossa’s unique oral Z-Endoxifen. The study’s primary goal is to establish the dose-response relation of daily administration of Endoxifen on reduction of MBD.
Study to take place in Stockholm
Also, the secondary endpoints will be assessing tolerability and safety and an exploratory endpoint evaluating MBD changes’ persistence. The study will take place in Stockholm, with roughly 240 participants receiving daily doses of oral Endoxifen or a placebo for six months. Stockholm’s South General Hospital will be conducting the study.
Atossa has successfully completed four clinical studies with its proprietary oral Endoxifen for the treatment of breast cancer and other breast disorders. Furthermore, Endoxifen has been employed in two extended access studies involving a breast cancer patient and an ovarian cancer patient.