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Find Clinical Drug Pipeline Developments & Deals by Atossa Therapeutics
Endoxifen (z-endoxifen) is the most active metabolite of the FDA approved selective estrogen receptor modulator (SERM), tamoxifen. It has demonstrated that the anti-estrogenic effects and is being evaluated for ER+/HER2+ breast cancer.
Endoxifen (z-endoxifen) is the most active metabolite of the FDA approved selective estrogen receptor modulator (SERM), tamoxifen. It has demonstrated that the anti-estrogenic effects and is being evaluated for ER+/HER2+ breast cancer.
Under the agreement, Societal CDMO will provide a range of its Clinical Trial Services offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, the most active metabolite of the FDA approved SERM, tamoxifen.
(Z)-endoxifen is the most active metabolite of the FDA approved selective estrogen receptor modulator (SERM), tamoxifen. It has demonstrated that the anti-estrogenic effects and is being evaluated for ER+/HER2+ breast cancer.
Endoxifen, an active metabolite of tamoxifen, which is an FDA-approved drug to treat ovarian and breast cancer. Endoxifen administered to breast cancer patients prior to surgery.
The positive assessment by the safety committee allows the study to now enroll the next cohort, which will be the third of a total of four cohorts and the first of two multi-dose, placebo controlled cohorts evaluating AT-301A over AT-301B.
The Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.
Atossa has enrolled and first dose of AT-301 in Phase 1 being administered by nasal spray. This group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active).
The study results show that treatment with Atossa’s proprietary Endoxifen for 20 days prior to unilateral mastectomy and for 18 months after surgery as an adjuvant did not lead to vasomotor symptoms commonly associated with tamoxifen.
The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.