Atossa Therapeutics Completes Pre-IND Meeting with U.S. Food & Drug Administration
Atossa Therapeutics (Nasdaq: ATOS) announced a significant milestone with the completion of a pre-investigational new drug (PIND) meeting with the FDA regarding its proprietary Z-endoxifen for treating breast cancer in the neoadjuvant setting. The FDA's feedback will aid in preparing a request to open an IND for a Phase 2 study, focusing on pre-menopausal women with ER+/HER2- breast cancer. Atossa plans to initiate the IND request in Q2 2022 and conduct a pharmacokinetic study alongside the Phase 2 trial, seeking to compare Z-endoxifen against standard treatment options.
- Completion of pre-investigational new drug meeting with FDA for Z-endoxifen.
- Plans to initiate an IND request for a Phase 2 study, indicating progress in development.
- Focus on a specific patient demographic (pre-menopausal women with ER+/HER2- breast cancer) which may enhance market potential.
- Regulatory approval risks associated with the IND application and subsequent studies.
- Potential delays in patient enrollment affecting study timelines.
Input Received on Pathway for Proprietary Z-Endoxifen to Treat Breast Cancer in Neoadjuvant Setting
SEATTLE, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces that it has completed a pre-investigational new drug (PIND) meeting with the FDA. The purpose of the meeting was to obtain input from the FDA on pre-clinical, clinical, manufacturing and regulatory matters in the U.S. for Atossa’s proprietary Z-endoxifen to treat breast cancer in the neoadjuvant (prior to surgery) setting.
“Holding a PIND meeting is a critical milestone in the regulatory pathway,” said Dr. Heather Fraser, Atossa’s VP Clinical, Regulatory and CMC. “The feedback we received will be very helpful in preparing our request to the FDA to open an IND for a multi-center Phase 2 study to further advance our Z-endoxifen in the neoadjuvant setting. We plan to focus our development on pre-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer for whom the current treatment options typically include drugs that suppress ovarian function and essentially force the patient into menopause. We look forward to opening an IND in the second quarter of 2022 and then commencing a Phase 2 study in this setting.”
“Despite the uncertainties and challenges created by the worldwide, COVID-19 pandemic in 2021, it is gratifying to be able to announce this major step forward for our proprietary Z-endoxifen program development in the U.S., the largest market for pharmaceuticals for the treatment of breast cancer,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The guidance from this meeting with the FDA, together with the ongoing non-clinical studies with Z-endoxifen and the initiation of a technology transfer process to establish a commercial cGMP manufacturing supplier to support the further drug development and ultimate commercial launch of Z-endoxifen, will put Atossa in an excellent position to continue the development of Z-endoxifen in 2022.”
Based in part on the feedback received from the FDA and subject to its approval, Atossa’s current plan, is to continue developing Z-endoxifen for the treatment of pre-menopausal women with ER+/HER2- breast cancer in the neoadjuvant setting. Atossa plans to apply to the FDA for an IND to conduct a Phase 2 study in the U.S. to compare Z-endoxifen to standard of care, which is typically ovarian functional suppression along with either an aromatase inhibitor or tamoxifen. Atossa also plans to conduct a pharmacokinetic run-in study as a part of the Phase 2 study to further define potential dose levels.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.
Forward-Looking Statements
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Z-endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse CFO and General Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com
Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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