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Atossa Therapeutics, Inc. Files for Swedish Regulatory Approval to Initiate a Phase 2 Study of Oral Endoxifen to Reduce Mammographic Breast Density
Drug Manufacturing for Clinical Study has been Established SEATTLE, March 02, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq:ATOS), a
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Drug Manufacturing for Clinical Study has been Established\nSEATTLE, March 02, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced that it has filed with the Swedish Medical Product Agency and the Institutional Review Board to initiate a Phase 2 study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States. Studies conducted by others have shown that MBD increases the risk of developing breast cancer, and reducing MBD can reduce the incidence of breast cancer.\n “This is an important milestone in the development of our oral Endoxifen product. Regulatory approval is necessary to commence the Phase 2 randomized, double-blinded, placebo-controlled study in Stockholm, which will include approximately 1,000 pre-menopausal women with MBD who will receive daily doses of Endoxifen or placebo for six months. We expect the Medical Product Authority will respond within 30 days and that the IRB approval will follow in the second quarter,” commented Steven Quay, M.D., Ph.D., Atossa’s Chairman and CEO. Atossa has established both primary and secondary sources of manufacturing for the clinical supply of its oral Endoxifen capsules. With over three years of experience manufacturing and supplying the oral Endoxifen capsules for its completed clinical studies, Atossa believes adequate drug supply will be available to support this Phase 2 study. The primary objective of the study is to determine if breast density changes compared to placebo and among different doses, with secondary endpoints to assess and characterize safety and tolerability. South General Hospital in Stockholm will be conducting this study at multiple sites, after having recently completed the company’s Phase 2 study of its topical form of Endoxifen. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. About Atossa Therapeutics Atossa Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breas...