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Atossa Therapeutics has selected PSI as the contract research organization (CRO) to manage its planned Z-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer. The study aims to evaluate safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity. Patient enrollment is expected to begin in Q4 2025, with topline data anticipated in 2026.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) has announced the selection of PSI as the contract research organization (CRO) to manage its planned Z-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer (mBC). The study, designed with input from the U.S. Food and Drug Administration (FDA), aims to evaluate safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity [1].

Patient enrollment for the study is expected to begin in Q4 2025, following the Investigational New Drug (IND) filing. Topline data is anticipated in 2026. The selection of PSI underscores Atossa's commitment to advancing Z-endoxifen into its final steps before Phase 3 development [1].

PSI, known for its excellence in global oncology trial execution, has a proven track record of delivering regulatory-grade data and achieving on-time enrollment across diverse geographies. The company's proprietary machine-learning feasibility platform, VISIONAL™, has contributed to its success in moving swiftly from Phase 2 into Phase 3 trials [1].

Atossa believes Z-endoxifen has the potential to become a first-in-class therapy in the multi-billion-dollar market for metastatic breast cancer. The drug, a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D), has demonstrated clinical activity even in tumors resistant to existing endocrine therapies [1].

The study is part of Atossa's broader pipeline, which includes additional Phase 2 studies in the ER+/HER2- neoadjuvant breast cancer setting and combination therapy with abemaciclib in women with early stage breast cancer at high risk of recurrence [1].

References:
[1] https://www.prnewswire.com/news-releases/atossa-therapeutics-selects-psi-as-contract-research-organization-for-pivotal-dose-ranging-study-of-z-endoxifen-in-metastatic-breast-cancer-302534234.html