Novel Breast Cancer Therapeutics Innovator Atossa (NasdaqCM: ATOS) Reports “All Objectives Successfully Met In Phase 1 Study”
Atossa Genetics Inc. (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported preliminary results this week from its Phase 1 dose escalation study of its proprietary topical Endoxifen. The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 48 healthy female subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of both topical and oral Endoxifen dosage forms in varying dose levels over 28 days. The study was conducted in two parts based on route of administration. Based on the number of women at high-risk of developing breast cancer and the number of patients who have survived breast cancer but are not benefiting from tamoxifen. Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could each potentially exceed $1 billion in annual sales. Additionally, Atossa expects to report the results from the oral arm of the study in the next 30 to 60 days.
Atossa confirmed that all objectives from its Phase 1 dose escalation study of its proprietary topical Endoxifen were successfully met as follows:
Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen.
Tolerability: Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.
Pharmacokinetics: Topical Endoxifen crossed the skin barrier when applied daily to the breast, as demonstrated by low but measurable Endoxifen blood levels detected in a dose-dependent fashion.
Dr. Steven C. Quay, CEO and President stated, “Based on these positive preliminary results, we are advancing our topical Endoxifen into Phase 2 studies. We look forward to announcing the results from the oral arm of our Phase 1 study in the coming 30 to 60 days.”
Atossa Genetics hosted a conference call to discuss their preliminary results A replay of the call is available through October 14, 2017. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10112105.
The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.
To learn more and track the progress of Atossa Genetics (NasdaqCM: ATOS) please visit the Vista Partners Company Dedicated Page and future commentary.
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