SEATTLE, March 26, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company
developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that the
Institutional Review Board (IRB) has approved the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in a
pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient. This IRB approval follows the FDA’s recent “safe to
proceed” letter and permits Atossa’s oral Endoxifen to be provided to the patient.
"IRB approval was the final step in making our oral Endoxifen available to this patient,” commented Dr. Steven C. Quay,
President and CEO of Atossa. “We are encouraged that the regulatory authorities recognize the potential for additional treatment
options for pre-menopausal breast cancer patients. The impact of our proprietary oral Endoxifen on this patient’s tumor during the
pre-surgical treatment window is consistent with research by others, and strongly supports the continued development of our
proprietary oral Endoxifen.”
Under the FDA expanded access IND program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this
patient.
About FDA Expanded Access
Sometimes called "compassionate use," expanded access is a potential pathway for a patient with serious disease or condition, or
an immediately life-threatening condition, to gain access to an investigational medical product (drug, biologic, or medical device)
for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. For
more information about this process, please see the FDA website: FDA Expanded Use Website
About Atossa's Proprietary Endoxifen in Breast Cancer
Endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to prevent new as well as recurrent disease in
breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen
is the most active. Studies by others have shown that breast cancer patients with endoxifen levels of 30 nM and above have a lower
risk for developing future breast cancer. Up to half of the patients taking tamoxifen do not produce therapeutic levels of
endoxifen, frequently because of limited liver metabolism capability.
Studies by others indicate that endoxifen's molecular mechanisms of action are concentration dependent and different than that
of other anti-estrogens, including fulvestrant. Pathway analysis of differentially regulated genes revealed substantial differences
related to endoxifen concentrations including significant induction of cell cycle arrest and markers of apoptosis following
treatment with high, but not low, concentrations of endoxifen.
Many patients taking tamoxifen eventually stop responding, becoming tamoxifen refractory. In a small study by others of oral
endoxifen use by tamoxifen refractory patients, endoxifen provided an acceptable safety profile and promising antitumor activity.
Another class of drugs called aromatase inhibitors are also frequently used to treat breast cancer. However, they are not
FDA-approved for use in pre-menopausal women and can only be given to pre-menopausal women in conjunction with drugs for ovarian
suppression/oblation, which can cause cardiovascular and other toxicities. Additionally, 20-30 percent of those taking aromatase
inhibitors may experience factures, bone pain or osteoporosis. Because of these potential advantages, Atossa is developing oral and
topical forms of Endoxifen.
About Atossa Genetics
Atossa Genetics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat
breast cancer and other breast conditions. For more information, please visit www.atossagenetics.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 actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by
Atossa, lower than anticipated rate of patient enrollment, higher than anticipated drop-outs by study participants including
because of skin irritations in our Phase 2 breast density study, results of clinical studies, the safety and efficacy of Atossa's
products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary
rights held by others, such as patent rights, 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.
Atossa Genetics Company Contact:
Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott Gordon
CorProminence LLC
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: (516) 222-2560
scottg@corprominence.com
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