Atossa Genetics Announces Institutional Review Board Approval of Oral Endoxifen as Post-Mastectomy Treatment for a U.S. Breas...
March 26 2019 - 8:30AM
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
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Sep 2023 to Sep 2024