Atossa Genetics Announces Phase 2 Study Contract for Oral Endoxifen to Reduce Mammographic Breast Density in Women
December 19 2019 - 8:30AM
Atossa Genetics Inc. (Nasdaq:
ATOS), a
clinical-stage biopharmaceutical company developing novel
therapeutics and delivery methods for breast cancer and other
breast conditions, today announced that it has contracted with
Stockholm South General Hospital in Sweden to conduct a Phase 2
study of Atossa’s proprietary oral Endoxifen to reduce mammographic
breast density (MBD) in women. 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.
MBD is an emerging public health issue, as studies conducted by
others have shown that MBD increases the risk of developing breast
cancer and that reducing MBD can reduce the incidence of breast
cancer.
“Atossa’s primary strategic objective is to develop oral
Endoxifen to reduce MBD and this Phase 2 study is a major milestone
in advancing this objective,” commented Steve Quay, M.D., Ph.D.,
President and CEO of Atossa. “Dr. Hall and his clinic are uniquely
qualified to lead this study as they recently successfully
completed the Phase 2 study of our topical Endoxifen, which
demonstrated MBD reduction and they have conducted numerous studies
using tamoxifen in both the treatment and prevention setting.”
The primary endpoint of the new Phase 2 study is to determine
whether oral Endoxifen administration results in an individual
change in MBD, which will be measured after three and six months of
treatment. The secondary endpoints are safety and tolerability.
Assuming the institutional review board (IRB) approves the
study, enrollment is expected to open in the first quarter of
2020.
Significant progress has been made with Atossa’s lead Endoxifen
program:
- Atossa has completed multiple Phase 1 clinical studies using
both a topical and oral (capsule and modified-release tablet)
formulations of Endoxifen, the results of which indicated that oral
Endoxifen was safe and well tolerated.
- Atossa’s recently completed Phase 2 study of topical Endoxifen
found that, despite study participants reporting skin rashes and
irritation, a statistically significant reduction in MBD was
achieved in women taking the higher dose form of topical Endoxifen
in as little as three months of dosing.
- In an FDA-approved, single patient, expanded access (or
“compassionate use”) study, a breast cancer patient receiving
Atossa’s oral Endoxifen experienced a significant reduction in
cancer cell biological activity - the Ki-67 activity decreased by
50 percent, and the estrogen receptor content decreased by over 20
percent.
Atossa’s Proprietary Endoxifen
Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an
FDA-approved drug to prevent new breast cancer as well as recurrent
breast cancer in breast cancer patients. Tamoxifen itself must be
broken down by the liver into active compounds (metabolites), of
which Endoxifen is the most active. Although oral tamoxifen is
approved to prevent breast cancer in "high-risk" women, it is used
by less than 5 percent of women with an increased risk of
developing breast cancer, including women with MBD, because of the
actual or perceived side effects and risks of tamoxifen.
Mammographic Breast Density (MBD)
Legislation has been recently enacted in over 35 states
requiring that women be notified if they have MBD and those
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 MBD and inform women
about their MBD status. There is no FDA-approved treatment for
MBD.
MBD has been shown in studies conducted by others to be an
independent risk factor for developing breast cancer. It is
estimated that approximately ten million women in the Unites States
have MBD. Atossa Genetics believes its Endoxifen may provide an
option for women to proactively reduce the mammographic density of
their breasts. Moreover, the company's Endoxifen may improve
mammography accuracy and patient care by unmasking cancerous tumors
that are otherwise obscured by high breast density.
Based on the number of women with MBD and the number of patients
who have survived breast cancer but are not fully benefiting from
taking tamoxifen, Atossa estimates that the potential markets for
its proprietary formulations of Endoxifen could potentially exceed
$1 billion in annual sales. Moreover, reducing the incidence of
breast cancer could significantly reduce healthcare costs.
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:
800-351-3902kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott GordonCoreIR377 Oak StreetConcourse 2Garden City, NY
11530Office: 516.222.2560scottg@CoreIR.com
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