Atossa Therapeutics, Inc. (NASDAQ: ATOS) stock declined by 27.51% at the last close while the ATOS stock price rises further by 9.09% in the pre-market trading session. Atossa Therapeutics is a clinical-stage biopharmaceutical business focused on discovering and developing new medications in unmet medical needs, with a current emphasis on breast cancer and COVID-19.
Significant Development
ATOS has released the final results of its Phase 2 clinical research of oral Endoxifen given within the “window of opportunity” between breast cancer diagnosis and surgery.
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- Primary Endpoint Met: Ki-67 was found to be reduced. Ki-67, a frequent indicator of tumor cell activity, was decreased by 65.1 percent from 25.6% at the screening to 6% on the day of surgery. Ki-67 was lowered by less than 25% in all patients, which might be clinically significant because past studies have demonstrated that a decrease of less than 25% improves long-term survival.
The following were the secondary endpoints:
Tolerance and safety: All adverse events were minimal and thought to be attributable to the study medication. There were no variations in vital signs, physical exams, or ECGs, and no aberrant laboratory findings (serum chemistry, hematology, coagulation, and urinalysis). Endoxifen was found to be safe and well-tolerated in this investigation based on these findings. The trial was not terminated due to any adverse occurrences.
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Other findings: Estrogen receptor expression declined from 100% attesting to 88.6% on operation day, but progesterone receptor expression rose from 84.3 percent to 92.9 percent. There was no link discovered between Ki-67 expression and Endoxifen levels.
Steven Quay, Atossa’s President, and Chief Executive Officer stated:
Based on these encouraging results, they are taking a variety of efforts to accelerate Endoxifen development. ATOS has started the official non-clinical toxicology study that will be required for a New Drug Application to gain marketing clearance for Endoxifen, and they want to submit to the US FDA as soon as feasible for authorization to perform clinical research here in the US. The next clinical trial will quantify pathological full response in the neoadjuvant context, according to their expectations. Despite the fact that there are many FDA-approved neoadjuvant treatments for breast cancers that are not estrogen receptor positive (ER+), there are presently very few approved therapies for the nearly 78 percent of breast cancers that are ER+, which they believe creates a significant unmet need for their Endoxifen.