Seattle-based healthcare company Atossa Genetics Inc. (NASDAQ:ATOS) has announced that they have received approval from the Swedish Medical Products Agency (MPA) to move on to Phase 2 of their treatment of women with mammographic breast density (MBD), Endoxifen.
According to the company’s press release, Phase 2 of the study will be done at the Stockholm South General Hospital in Sweden and will be led by Dr. Per Hall, the Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet, in Sweden.
Endoxifen is a topical treatment that the company hopes will reach the goal of having a change in MBD, while the secondary goal of the study is safety and tolerability.
This new treatment is formed from tamoxifen, which is already a drug that has been approved by the United States Food and Drug Administration (FDA).
Tamoxifen is said to help prevent recurrent breast cancer in breast cancer patients.
The reduction of MBD is said to reduce the risk of breast cancer and may also allow cancer to be discovered more easily during a mammography.
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MBD in 90 patients participating in the trial will be measured after three and six months of being part of the study.
The 90 patients will be divided into three groups of 30, which will include one placebo group and two groups with different doses of topical Endoxifen.
President and CEO of Atossa Genetics, Dr. Steven C. Quay has said that they “are honored to be working with Dr. Hall and his colleagues on [the company’s] Phase 2 study of MBD.”
Phase 1 of the endoxifen study had results which showed that the topical treatment was safe and well tolerated.
Shares of Atossa rose 29.97% to USD $4.38 on Monday, while the closing value on for Friday was $3.37.
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