Swedish MPA (Medical Product Agency) approved Atossa Therapeutics Inc (NASDAQ: ATOS) to carry out a phase 2 clinical trial of Oral Endoxifen to minimize mammographic breast density.
More than 10 million females in the US and several women worldwide are suffering from mammographic breast density (MBD).
According to recent studies, MBD reduces the chances of identifying cancer. As a result, females are prone to developing breast cancer. Reducing MBD helps females in reducing breast cancer incidence.
Atossa’s CEO, Steven Quay, said the company achieved a significant milestone in developing oral Endoxifen and expects to commence clinical trials after easing covid-19 restrictions in Stockholm. It is an encouraging sign that daily covid cases are declining in the past six weeks in Sweden.
If the same trend continues, Atossa will initiate a randomized, placebo-controlled, and double-blinded phase 2 clinical trial of oral Endoxifen in the next quarter. MPA also transmitted helpful information for the development of Endoxifen to Atossa.
Atossa will consider these inputs to conduct further trials of Endoxifen to measure its effectiveness in mitigating MBD and prevent breast cancer incidence. The company will also conduct toxicology studies of the drug and provide information about the manufacture of Oral Endoxifen for regulatory approval.
Atossa established two production sources for its innovative formulation to commence clinical studies and commercialization in the future. It already commenced a preclinical trial to support NDA (New Drug Application).
The primary endpoint of phase 2 clinical trial of Endoxifen is to identify the optimum dose for its effectiveness in reducing MBD. Atossa will assess the tolerability and safety of Endoxifen as a secondary objective of the trial.
Enrolls 240 subjects in Phase 2 clinical study
The company will enroll 240 pre-menopausal females with measurable MBD in phase 2 clinical trial. It will administer daily doses of Endoxifen or placebo for six months on the selected subjects at a Stockholm-based South General Hospital. Per Hall, the principal investigator will lead the trial.
Atossa stock trades at $5.35 (up 4.09%) on June 18, 2021. The stock gained 251% in just two months.
It will be included in the Russell 3000 Index and Russell 2000 Indexes with effect from June 28, 2021.
