Atossa Therapeutics Inc. (NASDAQ: ATOS) has commenced enrolment in Phase 2 clinical trial of oral Z-Endoxifen in Sweden. Study participants will be premenopausal women with elevated mammographic breast density, a public health issue that over 10 million the US and more globally face.
Study to determine Z-endoxifen in reduction of MBD
The company’s CEO and chairman Steven Quay stated, “This is an extremely important milestone as it marks the next phase of developing our proprietary Z-Endoxifen. This study will help determine the relationship between daily doses of Endoxifen and reduction in breast density and will help us further assess safety and tolerability. We look forward to providing progress updates as they become available.”
The Karisma-Endoxifeb trial is a second phase, a double-blind, randomized, placebo-controlled, dose-response trial of the company’s novel Oral Z-Endoxifen in premenopausal healthy women having measurable breast density. The study’s secondary endpoints will be to assess the tolerability and safety of the product, and the study includes an exploratory endpoint assessing the durability of breast density changes. The company will conduct the study at the South General Hospital in Stockholm. Around 240 subjects will be enrolled to receive oral Z-Endoxifeb or placebo for around six months. Per Hall, Head of De[apartment of Medical Epidemiology and Biostatistics at Karolinska Institutet will be the study’s principal investigator.
Endoxifen used in breast cancer treatment
Endoxifen is an FDA-approved active metabolite drug called tamoxifen that has been used wilder for almost 40 years in preventing and treating breast cancer. Most importantly, tamoxifen is a “pro-drug” that needs to be metabolized into active components for it to be effective. However, despite the drug’s success on estrogen-receptor-positive breast cancer, its system adverse events have contributed to low acceptance as a treatment in the reduction of breast cancer risk.
Presently there are over ten million women with mammographic breast density in the US, and there is no FDA-approved therapy for that. In addition, according to studies, MDB reduced mammograms’ ability to detect cancer which increases the risk of having breast cancer.
