Atossa Therapeutics Announces New Patent Despite PTAB Ruling
Atossa Therapeutics Responds to Patent Trial Decisions
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical enterprise focused on innovative treatments for breast cancer, has recently made headlines regarding U.S. Patent No. 11,572,334. This patent was subject to a ruling by the Patent Trial and Appeal Board (PTAB), which determined all claims challenging its validity as unpatentable.
Understanding the Impact of the PTAB Decision
According to the company, this ruling is disappointing, but they are evaluating their options moving forward. Importantly, Atossa reassures that the ruling will not affect ongoing clinical development of their formulations. While the company expressed disagreement with the PTAB, they have decided against pursuing an appeal due to the associated costs and time. Instead, Atossa plans to file a new Continuation Patent Application with the U.S. Patent Office to secure protection for formulations currently in development.
New Patent Issued for Endoxifen Composition
In a positive turn, Atossa announced the issuance of U.S. Patent No. 12,201,591, which pertains to “Sustained Release Compositions of Endoxifen.” This new patent includes 31 claims focused on the sustained release of this active compound, potentially enhancing therapeutic efficacy.
A Comprehensive Patent Estate
Atossa Therapeutics possesses a strong patent estate that encompasses various assets, including U.S. Patent No. 11,261,151, U.S. Patent No. 11,680,036, and U.S. Patent No. 12,071,391. These patents collectively support their innovative range of formulations in clinical trials. The issuance of the new patent reinforces Atossa’s commitment to broadening its patent portfolio as it continues to innovate in breast cancer treatments.
Leadership’s Perspective on the Future
Dr. Steven Quay, M.D., Ph.D., FCAP, the CEO of Atossa Therapeutics, reinforced the company’s commitment to providing improved treatment options for patients. He stated, “While we respectfully disagree with the PTAB’s decision, since it has no impact on the formulations that are currently under clinical development, we will focus on getting additional patent protection.” This focus is expected to drive Atossa’s ongoing efforts in the quest to advance its pharmaceutical offerings.
The Role of (Z)-Endoxifen in Breast Cancer Treatment
(Z)-endoxifen is recognized as a powerful Selective Estrogen Receptor Modulator (SERM) effective in inhibiting estrogen receptors, paving the way for potential degradation of these receptors. Notably, this compound has shown efficacy in treating patients who exhibit tumor resistance to typical hormonal therapies. Besides its excellent anti-estrogen performance, (Z)-endoxifen targets PKC?1, a protein associated with oncogenic processes.
Clinical Development of (Z)-Endoxifen
Atossa is actively developing an oral formulation of (Z)-endoxifen that is designed to bypass stomach acid, which could otherwise convert a significant portion of the compound into an inactive form. This innovative solution could significantly improve bioavailability. The clinical trials involving (Z)-endoxifen are underway, with five Phase 2 trials targeted at different groups, including healthy women and those diagnosed with ductal carcinoma.
Current Studies and Advancements
The ongoing studies in women with ER+/HER2- breast cancer include significant trials such as the EVANGELINE study, reflecting Atossa's commitment to gathering comprehensive data on the safety and effectiveness of (Z)-endoxifen. This research is paramount in expanding treatment options for patients facing breast cancer.
About Atossa Therapeutics
As a dedicated clinical-stage biopharmaceutical firm, Atossa Therapeutics, Inc. seeks to fill critical voids in oncology with innovative medicines, particularly using (Z)-endoxifen for breast cancer prevention and therapy. The company continues to cultivate its intellectual property and clinical advancements to better societal health outcomes significantly.
Frequently Asked Questions
What was the PTAB ruling regarding U.S. Patent No. 11,572,334?
The PTAB ruled that all challenged claims in the patent were unpatentable.
Will the PTAB ruling affect Atossa's clinical developments?
No, Atossa stated that the ruling will not impact the formulations currently in clinical development.
What new patent was issued recently by Atossa?
Atossa was issued U.S. Patent No. 12,201,591, which focuses on sustained release compositions of endoxifen.
Who is at the helm of Atossa Therapeutics?
Dr. Steven Quay serves as CEO of Atossa Therapeutics, guiding its strategic direction and commitment to improving patient outcomes.
What is (Z)-endoxifen, and why is it significant?
(Z)-endoxifen is a potent SERM that may treat breast cancer effectively and is currently undergoing multiple clinical trials to validate its efficacy.
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