Atossa Genetics Reports Results From “Expanded Access” Program for a U.S. Breast Cancer Patient Taking Oral Endoxifen: Si...
February 07 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 updated the status of the pre-menopausal,
estrogen-receptor positive (ER+) breast cancer patient who received
preoperative oral Endoxifen therapy under an FDA-approved “expanded
access” program. The purpose of this therapeutic approach was to
reduce activity of the cancer cells prior to surgery.
The patient received daily doses of Atossa’s oral Endoxifen for
approximately three weeks prior to surgery. There were no safety or
tolerability issues and her surgery was completed successfully. To
determine if the oral Endoxifen reduced the biological activity of
the cancer cells, the test results obtained from the initial biopsy
were compared with those from the specimen obtained during surgery.
A reduction of the cancer cell biological activity was observed by
a significant reduction in estrogen receptor content of the tumor.
Endoxifen interacts with the estrogen receptor preventing it from
functioning. Recent research by others suggests that endoxifen also
destroys the receptor.
“We are very encouraged by these results,” commented Dr. Steven
C. Quay, President and CEO of Atossa. “There is a significant
opportunity and need to reduce cancer cell activity prior to
surgery. As such, we are currently conducting a Phase 2 study with
our proprietary oral Endoxifen in this pre-operative, or ‘window of
opportunity,’ setting in Australia.”
Following her diagnosis, the patient sought options to the
current standard of care following surgery, which typically consist
of ovarian suppression and aromatase inhibitors. Because she was
not a candidate for tamoxifen therapy due to low liver enzyme
(CYP2D6) activity, and she did not want to go into early menopause,
her physician explored other treatment options. This search led to
Atossa’s oral Endoxifen and the request to the FDA for expanded
access (single-patient) in the “window of opportunity” setting in
the U.S.
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 a cytochrome P450 mediated, 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.
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. 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. 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 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 MBD 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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