This week Atossa Therapeutics’ President and CEO Dr. Steven C. Quay Issued an Annual Letter to Shareholders Highlighting Key Accomplishments and Strategy for 2020. Please review it below. TO OUR VALUED SHAREHOLDERS: 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 (MBD) 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. Recent highlights in advancing our goals include:
- Oral Endoxifen for MBD. Our lead program is to develop our proprietary oral Endoxifen to reduce MBD. MBD is an emerging public health issue affecting over 10 million women in the United States. Studies conducted by others have shown that MBD increases the risk of developing breast cancer and that reducing MBD can reduce the incidence of breast cancer. In 2019, we completed additional Phase 1 work with our oral Endoxifen, and, in December 2019, we contracted with South General Hospital in Stockholm, Sweden to conduct a Phase 2 study of our proprietary oral Endoxifen to reduce MBD.
- Oral Endoxifen in the Window of Opportunity Between Diagnosis and Surgery. In an FDA-approved, single patient, expanded access (or “compassionate use”) study, a breast cancer patient receiving our oral Endoxifen experienced a significant reduction in cancer cell biological activity – the Ki-67 activity decreased by 50 percent, and the estrogen receptor content decreased by over 20 percent. The patient has continued to take oral Endoxifen in the adjuvant setting following her surgery. We also have an ongoing Phase 2 study underway in Australia administering our oral Endoxifen to women in the window of opportunity.
- Topical Endoxifen for MBD. We have also been developing a topical form of Endoxifen which is applied to the skin like a lotion. In June 2019, we announced the results from our Phase 2 study using this topical formulation to reduce MBD, which indicated that our proprietary 20mg daily topical Endoxifen showed significant and rapid reduction in MBD. Because study participants experienced skin rashes and local irritation we will reevaluate the topical form once we complete the Phase 2 study of oral Endoxifen.
- Intraductal Microcatheter Technology. We recently advanced our intraductal microcatheter technology program with the IRB approval of a Phase 2 clinical study using our intraductal microcatheter technology to administer fulvestrant in patients with early-stage breast cancer or ductal carcinoma in situ (DCIS). The study is being conducted at a world-class teaching, research and healthcare organization based in the United States. We also advanced our intraductal R&D program by developing a model in mice using our intraductal microcatheter technology. This is an important accomplishment, as this model will enable us to identify potential immunotherapy candidates to move forward into clinical trials.
- 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.
Please visit the Atossa Genetics (ATOS) page at Vista Partners to keep up with their progress and to learn more daily about their work and developments in diagnosing and treating breast cancer.