Atossa Therapeutics Completes Pre-IND Meeting with U.S. Food & Drug Administration
December 06 2021 - 8:15AM
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 CounselOffice: (866) 893-4927kyle.guse@atossainc.com
Investor Relations Contact:Core IROffice: (516)
222-2560ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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