Atossa Genetics Announces FDA Approval of Oral Endoxifen for “Expanded Access” as Post-Mastectomy Treatment for a U.S. Br...
March 14 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 FDA has issued a “Safe to
Proceed” letter under their “expanded access” program permitting
the use of Atossa’s oral Endoxifen as a post-mastectomy treatment
in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer
patient. This patient completed a 3-week course of Atossa’s oral
Endoxifen prior to her surgery under an FDA-approved expanded
access program.
The tumor activity from the initial biopsy was compared to the
tumor activity at surgery, finding that the cancer cell biological
activity was reduced by two measures: the Ki-67 activity decreased
by 50 percent, and the estrogen receptor content decreased by over
20 percent. There were no safety or tolerability issues, including
vasomotor symptoms such as hot flashes and night sweats. The latter
symptoms are often a tolerability challenge for patients on
tamoxifen.
"We are extremely pleased that this patient not only benefitted
from Endoxifen prior to her surgery, but that the FDA agrees that
continued Endoxifen therapy is appropriate for this pre-menopausal
patient,” commented Dr. Steven C. Quay, President and CEO of
Atossa. “This positive progress supports our expansion of oral
Endoxifen clinical trials. After surgery is completed, the
current standard of care in the USA to prevent a recurrence and/or
a new cancer is for patients to undergo ovarian ablation (chemical
treatment to induce menopause) and take aromatase inhibitors (AI)
for 5 to 10 years. Alternatively, tamoxifen therapy can be
used for 5-10 years for those patients who do not want to take AIs,
or for whom these medications are contraindicated. This patient,
like many others, was not a good candidate for tamoxifen therapy
due to low liver enzyme (CYP2D6) activity which means her liver
would not adequately metabolize tamoxifen. Unlike tamoxifen, oral
Endoxifen does not require liver metabolism so it may be a better
treatment approach.”
The importance of Ki-67 as a marker of estrogen-receptor breast
cancer cell activity has evolved over the past few years. In a 2017
peer-reviewed paper1 in which a meta-analysis was conducted and
included 49 studies and 14,046 patients, five studies reported and
compared the change of Ki-67 following pre-surgery hormonal therapy
treatment and the disease-free survival (DFS). The authors reported
that from their analysis, a Ki-67 change that is either low or
none, as well as an increase, is associated with worse DFS. The
reduction of Ki-67 in the tumor of the patient who received oral
Endoxifen prior to her mastectomy is considered large, based on the
criteria of this paper.
Under the FDA expanded access IND program, the use of Atossa's
proprietary oral Endoxifen is restricted solely to this patient.
Approval from the Institutional Review Board (IRB) must be obtained
prior to providing oral Endoxifen 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
_______________________________
1Lun Li, Dongdong Han, Xiaowei Wang, Quan Wang, et al.
2017. Prognostic values of Ki-67 in neoadjuvant setting for
breast cancer: a systematic review and meta-analysis. Future
Oncol. https://www.ncbi.nlm.nih.gov/pubmed/28088868
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