Susan G. Komen is hosting the 2025 Tulsa Race for the Cure to raise money for breast cancer research and support services. The event aims to raise $210K, which will fund Komen's investment in research, patient care, and public policy initiatives. Breast cancer affects 1 in 8 women in the U.S. and 1 in 1,000 men, with an estimated 316,950 women and 2,800 men diagnosed with the disease in 2025. Komen provides direct support to Oklahomans through its Patient Care Center and has provided assistance to 277 patients in fiscal year 2025.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has selected PSI as the contract research organization (CRO) for its pivotal dose-ranging study of Z-endoxifen in metastatic breast cancer. The study, designed with input from the U.S. Food and Drug Administration (FDA), is expected to inform a subsequent Phase 3 trial. Patient enrollment is anticipated following the Investigational New Drug (IND) filing in Q4 2025, with topline data expected in 2026 [1].
Z-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with dual mechanisms of action: estrogen receptor inhibition and degradation, and direct inhibition of protein kinase C beta 1 (PKCβ1). It has demonstrated clinical activity in tumors resistant to existing endocrine therapies and could reshape the standard of care in breast cancer treatment [1].
PSI is recognized for its excellence in global oncology trial execution, with 93 percent of its studies enrolling on time or ahead of schedule in 2024. Atossa selected PSI following a competitive process for its proven ability to deliver regulatory-grade data, achieve on-time enrollment, and seamlessly scale programs into Phase 3 trials [1].
The market opportunity for Z-endoxifen is substantial, with approximately 5.6 percent of newly diagnosed invasive breast cancers in women in the U.S. being diagnosed at the metastatic stage. In total, there are an estimated 170,000 women living with metastatic breast cancer in the United States. Current therapies often fail due to resistance, leaving patients with limited options [1].
Atossa's pipeline includes additional Phase 2 studies in the ER+/HER2- neoadjuvant breast cancer setting, including monotherapy of Z-endoxifen in early stage breast cancer, combination therapy with abemaciclib in women with early stage breast cancer at high risk of recurrence, and monotherapy in women with a biopsy-proven diagnosis of ductal carcinoma in situ (DCIS) [1].
References:
[1] https://www.biospace.com/press-releases/atossa-therapeutics-selects-psi-as-contract-research-organization-for-pivotal-dose-ranging-study-of-z-endoxifen-in-metastatic-breast-cancer
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