Atossa Therapeutics Due To Meet FDA To Discuss The Clinical Development of Oral Endoxifen to Reduce Mammographic Breast Density (MBD)

By John Heerdink LinkedIn Disclaimer

MBD is an emerging public health issue affecting over 10 million women in the U.S. MBD is a recognized risk factor for future breast cancer and there is no approved therapy to reduce MBD. High-risk women are usually advised to have more frequent or sophisticated mammograms and to make lifestyle changes.

Today, Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced that it will meet with the U.S. FDA on April 30, 2020. The objective of this meeting is to discuss the clinical development of oral Endoxifen to reduce mammographic breast density (MBD).

This important meeting with the FDA is a critical step in developing our oral Endoxifen for the U.S. market. We expect a fruitful discussion that will help us shape our development program in the United States.” stated, Janet R. Rea, SVP Regulatory, Quality and Clinical Affairs (pictured).

Atossa further stated that as envisioned, a short course of oral Endoxifen may provide another option for women with high MBD. Atossa’s offices are located in Seattle, Washington and ongoing or planned clinical trials of Atossa’s Endoxifen are located in Australia and Sweden. Despite the well-publicized impacts of the current COVID-19 outbreak, Atossa’s operations, including clinical studies and the supply of Endoxifen, have not been negatively impacted. Sufficient quantities of the active pharmaceutical ingredient, Endoxifen, for the currently ongoing and planned clinical trials have been previously manufactured and are in secure storage. Management instituted a temporary policy of working from home, which has been in place since February 26, 2020, and of limited business travel. These policies remain in effect as of today. Finally, the Company has not been notified of any employee illness, as would be required by policy.

On March 3rd,  Atossa Therapeutics, Inc. (Nasdaq: ATOS) 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). 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.

“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” stated Atossa’s Chairman, and CEO, Steven Quay M.D., Ph.D. (pictured). Steven Quay received an M.D. and Ph.D. from The University of Michigan was a postdoctoral fellow at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital, and was on the faculty of Stanford University School of Medicine. His contributions to medicine have been cited over 9,600 times. He has founded six startups, invented seven FDA-approved pharmaceuticals, and holds 87 US patents. It is estimated that over 80 million people have benefited from the medicines he invented. His current passion is the prevention of the two million yearly breast cancer cases worldwide. 



Please visit the Atossa Therapeutics (ATOS) page at Vista Partners to keep up with their progress and to learn more daily about their work and developments in diagnosing and treating breast cancer. Shares of Atossa are trading up ~+17% currently today.

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