Breast cancer is said to be the second most common cancer in women after skin cancer. As of January 2021, there were over 3.8 million women with a history of breast cancer in the U.S., according to BreastCancer.org. Estrogen receptor-positive (ER-positive) breast cancer accounts for 78% of the breast cancers.
if a cancer has receptors for estrogen, it is called estrogen-receptor-positive. This suggests that cancer cells, like normal breast cells, may be stimulated to grow by estrogen-related signals. Studies have indicated that the 5-year survival rate for women with ER-positive breast cancer is better than for those with ER-negative breast cancer patients.
The stock we are bringing to your attention today is that of a clinical-stage biopharmaceutical company which is developing a drug for breast cancer – Atossa Therapeutics Inc. (ATOS).
The company’s lead drug candidate is Endoxifen, window of opportunity, or neoadjuvant, setting for potential indications like avoidance of surgery in older or frail patients allowing for breast conservation surgery, and use of Endoxifen in place of other neoadjuvant therapies.
Earlier this month, the company announced favorable final data from its Australian phase II clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery.
The company has begun the formal non-clinical toxicology program that will be needed for a New Drug Application to seek marketing approval for Endoxifen and also plans to seek FDA clearance to conduct a clinical study in the United States as soon as possible.
A phase II clinical study of oral Endoxifen for the reduction of mammographic breast density (MBD) is expected to be initiated in Sweden next quarter.
Mammographic breast density reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer. Over 10 million women in the United States and many more worldwide are affected by MBD.
Under the FDA expanded access program, oral Endoxifen is also being tested in one patient with ovarian cancer. This patient began treatment, i.e. with the drug combination of approved drug Piqray and oral Endoxifen, recently. Depending upon the result from this single-patient program, the company will consider conducting additional clinical studies in patients with ovarian cancer.
Another indication on which the company is focusing is Covid-19, and the drug candidate for this indication is AT-301 administered by nasal spray.
AT-301 was considered to be safe and well tolerated in healthy volunteers in a phase I study. The company is now preparing to conduct an additional preclinical study, following which it intends to seek FDA clearance to commence a phase II study in the United States.
As of March 31, 2021, Atossa had cash, cash equivalents and restricted cash of roughly $137.7 million.
ATOS has traded in a range of $0.81 to $6.82 in the last 1 year. The stock closed Monday’s (Jun.14, 2021) trading at $4.62, up 7.19%.
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