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Atossa Therapeutics Announces Clinical Progress
SEATTLE, April 02, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, April 02, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced recent progress with its Phase 2 study administering oral Endoxifen in the “window of opportunity” between diagnosis of breast cancer and surgery, as well as the company’s proposed Phase 2 clinical trial to reduce mammographic breast density (MBD).\n Updates on the company’s “window of opportunity” (WOO) Phase 2 trial include: Completed treating a sufficient number of patients to permit an initial report of study results from the pilot portion of the study.Contracted with Avance Clinical to open a second site for the study in Geelong, Victoria, Australia, with the goal of increasing the rate of enrollment.Applied to the Institutional Review Board for approval to open the second site in Geelong, Australia.Manufactured sufficient Endoxifen necessary for all patients expected to enroll in this study. Updates on the company’s planned Phase 2 trial to reduce MBD include: In February 2020, we applied with the Swedish regulatory authorities (the MPA and IRB) for approval to begin our Phase 2 clinical study of our oral Endoxifen to reduce MBD. The MPA provided questions about our application, as is typical, and we will be addressing those questions over the coming weeks. Because of the outbreak of COVID-19, health facilities in Sweden are not currently providing screening mammograms. As a practical matter, we cannot begin enrolling patients until screening mammograms recommence in Stockholm. We plan to begin this study as soon as we receive approval from the Swedish regulatory authorities and screening mammograms recommence.The company has manufactured all of the drug necessary for three months of dosing for the first 90 patients to be enrolled in the planned Phase 2 study. Additionally, Atossa submitted materials to the FDA in advance of its scheduled April 30 meeting, and has confirmed at least three years of stability data on its proprietary Endoxifen. “We are very pleased with the recent progress,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Once a patient is diagnosed with early stage breast cancer, it typically takes two to three weeks for surgery. During that ...