Atossa Therapeutics Inc (ATOS)

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About Atossa's Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to treat ovarian and breast cancer. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. In third party preclinical studies, endocrine-sensitive and letrozole-resistant breast tumors, Z-endoxifen resulted in robust antitumor and antiestrogenic activity compared to tamoxifen and aromatase inhibitor monotherapy.

Atossa has been developing its proprietary oral Endoxifen for breast cancer and other breast conditions and has successfully completed five clinical studies with this drug, including an expanded access study of a female breast cancer patient who has been taking oral Endoxifen for over two years, with no recurrence to date.

About Ovarian Cancer

In 2021 ovarian cancer will be diagnosed in about 21,400 women in the United States and about 13,770 women will die from the disease. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

About Alpelisib

Alpelisib was approved in the United States in 2019 for use in combination with the endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. PIK3 is a family of lipid kinases and one of them, PIK3CA, has mutations or gene amplification detected in 30.5% of all ovarian cancers and 45% of the endometrioid and clear cell subtypes. Alpelisib is marketed by Novartis under the brand name of Piqray.

About Atossa Therapeutics

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com

https://www.globenewswire.com/news-release/2021/03/11/2191501/0/en/Atossa-Therapeutics-Announces-Receipt-of-FDA-Safe-to-Proceed-Letter-for-Treatment-of-an-Ovarian-Cancer-Patient-with-Oral-Endoxifen-Under-Expanded-Access-Pathway.html