Atossa Genetics Announces Preliminary Results from Phase 1 Study of Modified-Release Tablet Oral Endoxifen
September 30 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 reported preliminary results from its
Phase 1 study of its proprietary modified-release tablet form of
oral Endoxifen. All objectives were successfully met:
- Safety: There were no unexpected
and serious adverse events; no clinically significant adverse
safety signals; and no clinically significant adverse events in
participants receiving the tablet form of oral Endoxifen. No
participants withdrew or were removed from the study due to skin
rashes and irritation or other adverse events (side
effects).
- Tolerability: The tablet form of oral
Endoxifen was well tolerated by each participant throughout the
study.
These results demonstrate the suitability of the tablet form of
oral Endoxifen for further clinical development.
“This was an important study because the results support
advancing our modified-release tablet into a Phase 2 study to
reduce mammographic breast density (MBD), which we plan to begin in
the fourth quarter by contracting with a CRO,” commented Dr. Steven
C. Quay, Ph.D., M.D., CEO and President of Atossa. “We will
continue our analysis of the Phase 1 data and plan to announce
additional results in the coming weeks. We also recently completed
a successful Phase 2 study of our topical form of Endoxifen in
which a significant reduction of MBD was achieved among study
participants who applied the stronger dose of topical Endoxifen.
Our success with the topical Phase 2 study and now the successful
Phase 1 study of the tablet, supports our plan to advance our
proprietary tablet into a Phase 2 study to reduce MBD.”
The Phase 1 Study
The Phase 1 study was conducted in Australia. The objectives of
the study were to assess safety and tolerability and to ascertain
the pharmacokinetics of the tablet. The study was randomized,
double-blinded and placebo-controlled with both single and
multiple-doses (daily for 14-days) in two groups with a total of 24
healthy female volunteers. Atossa's oral Endoxifen capsule served
as the comparator.
Mammographic Breast Density (MBD)
Legislation has been recently enacted in approximately 35 states
requiring that women be notified if they have mammographic breast
density (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 breast density and inform women about their breast
density.
It is 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, it is used by less than 5 percent of
women with an increased risk of developing breast cancer because of
the actual or perceived side effects and risks of tamoxifen. Atossa
Genetics believes its Endoxifen may provide an option for women to
proactively reduce the 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.
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 GordonCoreIR377 Oak StreetConcourse 2Garden City, NY
11530Office: 516.222.2560scottg@CoreIR.com
*Joanne E. Mortimer, Shirley W. Flatt, Barbara A.
Parker, Ellen B. Gold et al. Breast Cancer Res Treat. 2008 Apr;
108(3): 421–426. Published online 2007 May
31. doi: 10.1007/s10549-007-9612-x
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