Steven Quay, MD, PhD, CEO & Founder, Kyle Guse CFO, & B. Heather Fraser, Ph.D. VP Clinical, Regulatory & CMC of Atossa Therapeutics (NASDAQ: ATOS) delivered a Tribe Public Event presentation titled “Discussion of Atossa’s Final Data from its Phase 2 Study of Endoxifen Administered to Breast Cancer Patients Prior to Surgery.” They were also be available for a Q&A session at the end of the presentation.
Dr. Quay is an author, entrepreneur, and accomplished physician-scientist that has founded six startups invented seven FDA-approved pharmaceuticals and holds 87 US patents. Over 80 million people have benefited from the medicines he invented. He received his M.D., M.A., and Ph.D. from The University of Michigan. He was a postdoctoral fellow at MIT with Nobel Laureate H. Gobind Khorana and a resident at the Harvard-Massachusetts General Hospital. He was on the faculty of Stanford University School of Medicine for almost a decade.
Atossa Therapeutics (NASDAQ: ATOS), is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19.
Prior to the event Atossa announced the following final data from its Phase 2 clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery.
Primary Endpoint Met:
Reduction in Ki-67 was achieved. Ki-67, a common measure of tumor cell activity, was reduced from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. Ki-67 was reduced below 25% for all patients, which is potentially clinically meaningful because studies by others have shown that a reduction below 25% improves long term survival.
Secondary Endpoints Were as Follows:
Safety and tolerability: All adverse events were mild and considered related to the study drug. There were no abnormal laboratory findings (serum chemistry, hematology, coagulation, urinalysis) and no differences in vital signs, physical examinations and ECGs. Based on these results, Endoxifen was considered safe and well tolerated in this study. No adverse events led to discontinuation of the study.
Other Results:
Estrogen receptor expression decreased from 100% at screening to 88.6% on the day of surgery and progesterone receptor expression increased from 84.3% at screening to 92.9% on the day of surgery. No correlation between Ki-67 expression and Endoxifen levels was observed.
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