Atossa Therapeutics, Inc. has received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) for its investigational new drug application concerning the treatment of metastatic breast cancer with (Z)-endoxifen. This regulatory approval represents a significant milestone for the Seattle-based biopharmaceutical company as it seeks to expand treatment options for patients with metastatic ER+/HER2- breast cancer.
Dr. Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa Therapeutics, stated, “This letter marks an important regulatory milestone for Atossa and potentially expands the use of (Z)-endoxifen. We believe its activity, even in tumors that have developed resistance to other endocrine therapies, may provide a new tool in treating this disease.”
Potential of (Z)-Endoxifen in Oncology
(Z)-endoxifen is recognized as a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated efficacy across multiple mechanisms of action. The drug is currently under evaluation for its potential applications in oncology and rare diseases. Atossa’s proprietary oral formulation boasts a favorable safety profile and pharmacological properties that are distinct from tamoxifen, including targeted effects on estrogen receptors and inhibition of the protein kinase C beta 1 (PKCβ1) pathway.
While (Z)-endoxifen is not yet approved for any specific medical indication, the company is advancing its clinical investigation with a growing global intellectual property portfolio. This includes multiple recently issued U.S. patents and several pending applications worldwide, underscoring Atossa’s commitment to developing innovative therapies.
Company Overview and Future Directions
Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on creating innovative treatments in oncology and other areas of significant unmet medical need. The company’s lead product candidate, (Z)-endoxifen, is currently in development across various clinical settings.
As the company progresses with its clinical studies, it is essential to note that forward-looking statements in this announcement reflect expectations about the development and regulatory strategy concerning (Z)-endoxifen. Risks and uncertainties may affect the results of clinical trials, the likelihood of regulatory approvals, and the company’s ability to maintain compliance with listing requirements on Nasdaq.
Dr. Quay expressed gratitude for the FDA’s review and emphasized the importance of advancing this clinical investigation. As Atossa Therapeutics continues to push the boundaries of cancer treatment, the potential impact of (Z)-endoxifen could be significant for patients facing challenging metastatic breast cancer diagnoses.
For further details about Atossa Therapeutics and its ongoing research, visit the company’s official website at https://atossatherapeutics.com.
