Atossa Genetics Announces Completion of Enrollment and Dosing in Phase 1 Clinical Trial of New Proprietary Modified-Release O...
September 03 2019 - 8:00AM
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 all participant activities
have been completed in its Phase 1 clinical trial of a new
proprietary modified-release oral tablet form of its Endoxifen.
This is the next generation of oral Endoxifen following the
successful clinical studies of the capsule form of the company’s
oral Endoxifen.
Steven C. Quay, Ph.D., M.D., CEO and president of Atossa,
commented: “We are very pleased that this study enrolled so
quickly, with all 24 participants enrolled and dosed over the past
six weeks. This is a very important study for Atossa as we plan to
use the new modified-release oral tablet in our upcoming Phase 2
study to reduce breast density. We expect to report preliminary
results from the Phase 1 study in the next 30 days and then move
forward with the Phase 2 study in the fourth quarter. Ultimately,
the goal of the modified-release aspect of the drug is to create
more even uptake of the drug which we believe may reduce side
effects and improve efficacy.”
The Phase 1 study is being conducted in Australia. The
objectives of the study are to assess safety and tolerability and
to ascertain the pharmacokinetics of the tablet. The study is
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.
About 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.
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 Counsel(O)
866-893-4927kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott GordonCoreIR377 Oak StreetConcourse 2Garden City, NY
11530Office: 516.222.2560scottg@CoreIR.com
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