Atossa Genetics Announces New Proprietary Modified-Release Oral Endoxifen Tablet; Phase 1 Clinical Trial Initiated
July 11 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 is developing a new
proprietary modified-release oral tablet form of its Endoxifen,
which is the form of the drug that the company intends for future
clinical studies and commercialization. This is the next generation
of oral Endoxifen following the successful clinical studies of the
capsule form of the company’s oral Endoxifen. A patent application
covering the new table has also been filed with the U.S. Patent and
Trademark Office.
Steven C. Quay, Ph.D., M.D., CEO and president of Atossa,
commented: “We are excited to take this next step in our oral
Endoxifen product development. Based on the abundance of
information from our previous clinical studies, we strongly believe
in the potential efficacy of oral dosing and intend for this
modified-release tablet to be the commercial form of our oral
Endoxifen. 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.”
As part of the development of this new oral tablet, Atossa has
commenced a Phase 1 study in Australia to ascertain the
pharmacokinetics of the tablet. The study is randomized,
double-blinded and placebo-controlled with both single and
multiple-doses in 2 groups with a total of 24 healthy female
volunteers who will be dosed for 14 days. Atossa’s oral Endoxifen
capsule, which has been used in previous clinical studies, will
serve as the comparator. The first group of the study has now been
enrolled and dosed.
Dr. Quay continued: “This new study builds on the success of our
Phase 1 studies of the oral capsule and topical forms of our
Endoxifen, our recent successful Phase 2 study of topical
Endoxifen, which demonstrated significant efficacy in reducing
breast density, and our single-patient compassionate use study of
oral Endoxifen. Following completion of this Phase 1 trial, we will
continue to use this proprietary modified-release formulation for
future clinical studies -- including a Phase 2 trial that we have
already indicated is in development -- and ultimately regulatory
approval. We look forward to completing the study in the next
quarter.”
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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