Atossa Therapeutics Announces Clinical Progress
April 02 2020 - 8:00AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company developing novel therapeutics and
delivery methods to treat breast cancer and other breast
conditions, today announced recent progress with its Phase 2 study
administering oral Endoxifen in the “window of opportunity” between
diagnosis of breast cancer and surgery, as well as the company’s
proposed Phase 2 clinical trial to reduce mammographic breast
density (MBD).
Updates on the company’s “window of opportunity” (WOO) Phase 2
trial include:
- Completed treating a sufficient number of patients to permit an
initial report of study results from the pilot portion of the
study.
- Contracted with Avance Clinical to open a second site for the
study in Geelong, Victoria, Australia, with the goal of increasing
the rate of enrollment.
- Applied to the Institutional Review Board for approval to open
the second site in Geelong, Australia.
- Manufactured sufficient Endoxifen necessary for all patients
expected to enroll in this study.
Updates on the company’s planned Phase 2 trial to reduce MBD
include:
- In February 2020, we applied with the Swedish regulatory
authorities (the MPA and IRB) for approval to begin our Phase 2
clinical study of our oral Endoxifen to reduce MBD. The MPA
provided questions about our application, as is typical, and we
will be addressing those questions over the coming weeks. Because
of the outbreak of COVID-19, health facilities in Sweden are not
currently providing screening mammograms. As a practical
matter, we cannot begin enrolling patients until screening
mammograms recommence in Stockholm. We plan to begin this study as
soon as we receive approval from the Swedish regulatory authorities
and screening mammograms recommence.
- The company has manufactured all of the drug necessary for
three months of dosing for the first 90 patients to be enrolled in
the planned Phase 2 study.
Additionally, Atossa submitted materials to the FDA in advance
of its scheduled April 30 meeting, and has confirmed at least three
years of stability data on its proprietary Endoxifen.
“We are very pleased with the recent progress,” said Dr. Steven
Quay, Atossa’s President and Chief Executive Officer. “Once a
patient is diagnosed with early stage breast cancer, it typically
takes two to three weeks for surgery. During that time, the tumor
continues to grow and we believe there is a compelling opportunity
to treat these women during this ‘window of opportunity’ to reduce
the tumor growth activity. Now that we have competed the treatment
on a sufficient number of patients in the WOO study, we look
forward to reporting initial study results. Last year, we provided
oral Endoxifen on a ‘compassionate use’ basis to a pre-menopausal
woman in the United States during this window of opportunity and
saw a 50% reduction in tumor cell activity, as measured by
Ki-67.”
The WOO Study and Market Opportunity
Atossa’s Phase 2 study of its oral Endoxifen in the window of
opportunity between diagnosis of breast cancer and surgery is
currently being conducted in Australia. The study will enroll up to
25 newly-diagnosed patients with ER+ and human epidermal growth
factor receptor 2 negative (HER2-) stage 1 or 2 invasive breast
cancer, requiring mastectomy or lumpectomy. Patients will receive
Atossa’s proprietary oral Endoxifen for at least 14 days from the
time of diagnosis up to the day of surgery. The primary endpoint is
to determine if the administration of oral Endoxifen reduces the
tumor activity as measured by Ki-67 (a measure of cellular
proliferation that correlates with tumor growth). A small study
showed that a reduction of Ki-67 during the window of opportunity
suggests a better outcome in these patients (Fasching et al. BMC
Cancer 2011, 11:486). 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 Avance
Clinical, which successfully completed four Phase 1 studies of
Atossa’s Endoxifen.
The American Cancer Society (ACS) estimates that in 2020,
276,480 women will be diagnosed with breast cancer in the
U.S. Every two minutes an American woman is diagnosed with breast
cancer and 42,170 die each year. Although about 100 times less
common than in women, breast cancer also affects men. The ACS
estimates that the lifetime risk of men getting breast cancer is
about 1 in 1,000; 2,620 new cases of invasive breast cancer
will be diagnosed in 2020; and 520 men will die from
breast cancer in 2020.
The MBD Study and Market Opportunity
The primary objective of the company’s MBD study is to determine
if breast density changes compared to placebo and among different
doses, with secondary endpoints to assess and characterize safety
and tolerability. South General Hospital in Stockholm, Sweden will
be conducting this study at multiple sites, after having recently
completed the company’s Phase 2 study of its topical form of
Endoxifen. The study is being led by principal investigator Per
Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology
and Biostatistics at Karolinska Institutet.
Legislation that has been recently enacted in over 40 states
requiring that women be notified if they have MBD. These
notifications typically state that women with MBD have a higher
risk of developing breast cancer, and that mammography may not be
as effective in detecting breast cancer because the MBD can “mask”
the detection of cancers. In February 2019, Federal legislation was
enacted that requires that the FDA adopt rules requiring that
mammography reports include information about breast density and
inform women about their breast density.
It has been estimated that approximately ten million women in
the Unites States have MBD, for which there is no FDA-approved
treatment. Although oral tamoxifen is approved to prevent breast
cancer in “high-risk” women (typically based on responses to a
questionnaire), it is used by less than 5% of women with an
increased risk of developing breast cancer because of the actual or
perceived side effects and risks of tamoxifen. We believe our
Endoxifen may provide an option for women to proactively reduce the
density of their breasts. Moreover, our Endoxifen may improve
mammography accuracy and patient care by unmasking cancerous tumors
that are otherwise hidden by breast density.
About Atossa Therapeutics
Atossa Therapeutics, 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.atossatherapeutics.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 Form10-K and 10-Q, each
as amended and supplemented from time to time.
Company Contact: Atossa Therapeutics, Inc. Kyle Guse CFO and
General Counsel Office: 866 893-4927 kyle.guse@atossainc.com
Investor Relations Contact: Scott Gordon Core IR377 Oak
StreetConcourse 2Garden City, NY 11530Office:(516)
222-2560scottg@corprominence.com
Source: Atossa Therapeutics, Inc.
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