Full Press Release Details
SEATTLE, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced the appointment of Dr. Arezoo Mirad as Senior Medical Director.
“We are excited to welcome Dr. Mirad to Atossa and look forward to leveraging her extensive experience in the clinical development of oncology candidates to further accelerate our (Z)-endoxifen development program,” said Dr. Steven Quay, CEO and Chairman of Atossa Therapeutics. “With four ongoing Phase 2 trials in three distinct settings, several years of working capital and important data expected in 2024, we are well positioned to achieve our goal of meaningfully improving the current standard of care for cancer patients.”
Prior to joining Atossa, Dr. Mirad served as Medical Director for Corcept Therapeutics, a commercial-stage biotech engaged in the discovery and development of medications to treat severe endocrine, oncology, metabolism and neurology disorders. In this role she acted as the lead medical monitor for global phase 2 and 3 registrational oncology clinical trials, led global site selection, and oversaw regulatory interactions. Dr. Mirad previously served as Medical Director for Alkermes, a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. In this role, she oversaw a multi-center phase 3 registrational clinical trial and developed clinical trial designs for gynecologic & aerodigestive tract tumors.
Earlier in her career, Dr. Mirad oversaw the clinical development of a peptide-based mRNA vaccine for COVID-19 while serving as Medical Director for Silicon DynamiX and served as Chief Research Analyst at the University of Colorado, where she received her M.D. She also received a M.S. in Mathematics from The University of North Carolina at Charlotte.
“(Z)-endoxifen is a compelling asset that I believe will meaningfully improve outcomes for breast cancer patients,” remarked Dr. Mirad. “I look forward to working with the Atossa team and study investigators to advance each of the ongoing Phase 2 trials and regulatory authorities as we continue to think through plans for Phase 3 registrational studies, with the goal of getting (Z)-endoxifen approved and to patients as quickly as possible.”
(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. (Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, 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.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. For more information, please visit www.atossatherapeutics.com
VP, Investor and Public Relations
FORWARD LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or other comparable words. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim and final clinical results; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.