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ATOS

Atossa Genetics

$1.50 /

-0.02 (-1.32%)

08:40
01/22/20
01/22
08:40
01/22/20
08:40

Atossa says advancing oral Endoxifen through phase 2 study primary goal in 2020

Atossa Therapeutics issued the following letter from Dr. Steven Quay, President and CEO, to Atossa shareholders. The letter read in part, "I begin this letter with a sense of great pride about our accomplishments at Atossa. During 2019, we focused on developing our proprietary drug Endoxifen to reduce mammographic breast density and to treat breast cancer after a woman is diagnosed but before her surgery. We advanced our goal of developing our intraductal microcatheter technology to deliver drugs and immunotherapies to treat breast cancer...Moving forward in 2020, we will continue to pursue our mission with vigor and dedication: Oral Endoxifen to Reduce MBD. Our primary goal in 2020 is advancing oral Endoxifen through a Phase 2 study to reduce MBD. The primary objective of this randomized, double-blinded, placebo-controlled study is to determine if there was a change in breast density compared to placebo and among different doses, with secondary endpoints to assess and characterize safety and tolerability. South General Hospital in Stockholm will be conducting this study at multiple sites, after having recently completed our Phase 2 study of our topical form of Endoxifen. The study is being led by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. We expected to enroll approximately 1,000 pre-menopausal participants in four groups who will be dosed for six months. In 2019, we completed additional Phase 1 work using our capsule Endoxifen and a new modified-release form of our oral Endoxifen. Study results showed that the capsule and tablet were safe and well-tolerated. Because the pharmacokinetics of the tablet did not appear to be significantly improved over our capsule and because the capsule is more cost-effective to manufacture, we plan to use our capsule formulation of Endoxifen in our upcoming Phase 2 study to reduce MBD. Upcoming 2020 milestones with this program include receiving approval to open the study from the Institutional Review Board and Medical Products Authority in the first quarter 2020. We will then begin enrolling participants in the first or second quarter of 2020 and we expect to report periodically the progress with enrollment. Oral Endoxifen in the "Window of Opportunity" Between Diagnosis of Breast Cancer and Surgery. We plan to continue enrolling participants in this Phase 2 study being conducted in Australia. Intraductal Technology. We plan to continue our Phase 2 study using our intraductal technology to administer Fulvestrant and we will be conducting additional pre-clinical work to identify potential immunotherapy candidates. Gynecomastia. Completing our Phase 2 study of MBD will help inform next steps with our program to treat and/or prevent gynecomastia with our proprietary Endoxifen. Accordingly, we don't anticipate advancing our gynecomastia program in 2020."

ATOS Atossa Genetics
$1.50 /

-0.02 (-1.32%)

12/18/19 Maxim
Atossa Genetics upgraded to Buy from Hold at Maxim
06/27/19 Maxim
Maxim downgrades Atossa Genetics to Hold on high endoxifen discontinuations
06/27/19 Maxim
Atossa Genetics downgraded to Hold from Buy at Maxim

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