Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announces that the United States Patent and Trademark Office (USPTO) has granted a new patent (No. 11,680,036) directed to enterically encapsulated endoxifen compositions formulated as a suspension. These include all liquid suspension formulations suitable for oral administration and dispersible tablets, powders, granules, pellets or sprinkles for reconstitution, which are commonly used for pediatric administration. A short video explaining the new patent can be found here: Suspension Patent Update.
A suspension is a heterogeneous mixture. It differs from a solution, which is a homogeneous mixture, in that the particles in a solution are much smaller and are dissolved in a solvent, therefore staying mixed together. In a suspension, the particles are large, do not dissolve, and will separate. Advantages of suspension formulations may include ease of delivery of low soluble therapeutic agents, increased bioavailability of drug dosage, controlled drug delivery and resistance to degradation.
“Our new patent covering suspension formulations is important as we continue to learn more about the potential therapeutic role of endoxifen beyond breast cancer and mammographic breast density,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Suspension formulations are particularly useful in pediatric applications where drugs are often dosed by weight and delivered via powders or sprinkles mixed with food and dispersible tablets, which are easier for children to ingest compared to tablets.”
About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.
Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. The Company is currently studying (Z)-endoxifen in three Phase 2 studies: one in healthy women with measurable breast density and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.
