Studies show that a reduction in breast density reduces the risk of developing breast cancer in women and could improve the accuracy of mammography in finding cancer.
The primary endpoint of this Phase 2 study is to determine if topical Endoxifen results in a change in mammographic breast density (MBD), which will be measured at three months and at six months after entering the study. The secondary endpoints in the study, which will analyze ninety participants, are safety and tolerability.
“The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study,” according to Atossa.
The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by Dr Per Hall, head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.
Last week, the company completed dosing and clinical visits in a Phase 1 study of its proprietary topical endoxifen for treatment of gynecomastia, or male breast enlargement, in men.
Maxim has bullish take
Jason McCarthy, a research analyst with Maxim Group, is bullish on Endoxifen and is keeping a Buy rating and a $10 price target on Atossa’s stock.
“Catalysts lay ahead as data emerges from ongoing and upcoming studies, which if positive should drive a higher valuation,” he wrote. “Both the topical and oral formulations of endoxifen continue to advance and management is executing on its clinical strategy.”
Atossa also plans to start a Phase 2 study to assess the worth of Endoxifen when taken orally by newly-diagnosed breast cancer patients.
Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients.
Atossa shares were recently up 1.6% to US$2.38.