Atossa Therapeutics Inc (NASDAQ:ATOS) has announced that its Karisma-Endoxifen clinical trial has reached full enrollment, sending its shares more than 2% higher on Monday morning.
The clinical-stage biopharmaceutical company said participants in the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with measurable mammographic breast density (MBD) have been randomized to placebo, 1 mg, and 2 mg daily doses of (Z)-endoxifen and will be treated for six months.
Throughout the trial, it said mammograms will be conducted to measure reduction in MBD, with any change used as a proxy for therapy response.
“Many of the risk factors for breast cancer, including breast density, are known, which means treating at-risk patient populations before the disease develops could significantly lower incidence rates,” commented Dr Per Hall, Professor of Epidemiology at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, and principal investigator of the Karisma-Endoxifen study.
“I expect the medical community and government entities to increase their focus on breast cancer prevention, which should expedite the development and availability of novel treatments like (Z)-endoxifen.”
Atossa noted that between 40% and 50% of all women are estimated to have mammographically dense breasts, which makes mammography less sensitive and mammograms more difficult to interpret since cancer and dense breast tissue both appear white on a mammogram.
In women with the highest density, approximately 50% of all breast cancers are missed on a mammogram and diagnosed in the interval between two screening rounds. Because of this, interval cancers are often larger, more advanced, and more difficult to treat.
The company said women with the highest density are also four to six times more likely to develop breast cancer in their lifetime compared to women with the least dense breasts.
“While significant progress has been made in breast cancer treatment, the same cannot be said about breast cancer prevention, particularly in high-risk women,” said Dr Steven Quay, Atossa’s president and CEO.
“(Z)-endoxifen is currently being studied in two populations that are at high risk of developing breast cancer, women with elevated breast density and women with ductal carcinoma in situ. Both diagnoses are strong, independent predictors of breast cancer risk that we feel are modifiable with (Z)-endoxifen.”
The company's shares traded 2.2% up at $0.70 by midday in New York.
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
~Updated with share price movement~
Contact the author at stephen.gunnion@proactiveinvestors.com