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 FDA has approved an “expanded
access” of Atossa’s proprietary oral Endoxifen in the preoperative
setting in a U.S. patient awaiting surgery for breast cancer.
Steven C. Quay, Ph.D., MD, President and CEO commented, “A
physician recently contacted Atossa and requested our proprietary
oral Endoxifen for a pre-menopausal, estrogen-receptor positive
(ER+) breast cancer patient awaiting surgery. In this setting, the
recommended preoperative endocrine systemic therapy is typically an
aromatase inhibitor and a drug for ovarian suppression. The
patient’s physician was reluctant to use this preoperative therapy
as it typically induces menopause and can have other potentially
serious side effects. We worked with the physician to apply to the
FDA to provide “expanded access” (formerly known as compassionate
use) to this patient under an Investigational New Drug (IND)
application. We are very pleased to report that the FDA approved
this single-patient study, and the patient is currently receiving
our proprietary oral Endoxifen preoperatively.”
Quay added, “This is the same clinical setting as our Phase 2
‘window of opportunity’ study of preoperative systemic oral
Endoxifen in breast cancer patients which is open for enrollment in
Australia.”
Under the FDA Expanded Access IND program, the use of Atossa’s
proprietary Endoxifen is restricted to this patient
only.
About FDA Expanded Access
Sometimes called “compassionate use,” expanded access is a
potential pathway for a patient with an immediately
life-threatening condition or serious disease or 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. Expanded access may be appropriate when all the
following apply: patient has a serious disease or condition, or
whose life is immediately threatened by their disease or condition;
there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition; patient
enrollment in a clinical trial is not possible; potential patient
benefit justifies the potential risks of treatment; providing the
investigational medical product will not interfere with
investigational trials that could support a medical product’s
development or marketing approval for the treatment indication.
Investigational drugs, biologics or medical devices have not yet
been approved or cleared by FDA and FDA has not found these
products to be safe and effective for their specific use.
Furthermore, the investigational medical product may, or may not,
be effective in the treatment of the condition, and use of the
product may cause unexpected serious side effects.
For more information, see the FDA website: FDA Expanded Use
Website
About Atossa's Proprietary Endoxifen in Breast
Cancer
Endoxifen is a cytochrome P450 mediated, active metabolite of
tamoxifen, 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% 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.
Atossa’s Phase 2 Study of Preoperative Systemic Oral
Endoxifen
Atossa is currently conducting a Phase 2 study of its oral
Endoxifen in Australia in the "window of opportunity" between
diagnosis of breast cancer and surgery. "Once a patient is
diagnosed with breast cancer, there is a window of time, typically
a few weeks, before surgery is performed," commented Dr. Quay. "Our
goal with this study is to show that our proprietary oral Endoxifen
can modify the cancer activity in ER+ breast cancer during this
'window of opportunity.' Because our Phase 1 study indicated that
our oral Endoxifen reaches therapeutic levels within 8 hours and
therapeutic steady-state levels in only seven days, we are
optimistic we can achieve a valuable treatment effect," added Dr.
Quay.
The Pilot Phase of the study will initially enroll up to eight
newly-diagnosed patients with ER+ and HER2 negative (HER2-) stage 1
or 2 invasive breast cancer, requiring mastectomy or lumpectomy.
Patients will receive Atossa's proprietary oral Endoxifen for at
least 21 days from the time of diagnosis up to the day of surgery.
Provided tumor activity reduction is demonstrated in at least two
patients, an additional 17 patients will be enrolled for a total of
25. The primary endpoint is to determine if the administration of
oral Endoxifen reduces the tumor activity as measured by Ki-67,
which is a marker of cellular proliferation. The secondary
endpoints are safety and tolerability and assessment of the study
drug on expression levels of both estrogen and progesterone
receptors. The impact on additional markers of cellular activity
will also be explored. The Phase 2 study is being conducted on
behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA,
Australia. CPR Pharma recently completed the successful Phase
1 study of Atossa's oral and topical Endoxifen in women.
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 any variation between
preliminary 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, lower than
anticipated rate of patient enrollment, estimated market size of
drugs under development, 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 with respect to fulvestrant, such
as patent rights, potential market sizes for Atossa’s drugs under
development 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 GuseCFO and General CounselOffice: 866
893-4927kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott GordonCorProminence LLC377 Oak StreetConcourse 2Garden
City, NY 11530Office: (516) 222-2560scottg@corprominence.com
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