Atossa Genetics Contracts with Additional Manufacturer of Endoxifen
August 01 2018 - 8:00AM
Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a
clinical-stage biopharmaceutical company developing novel
therapeutics and delivery methods to treat breast cancer and other
breast conditions, today announced that is has added Alchem
Laboratories as a U.S. contract manufacturer to supply Endoxifen.
Subject to successful bioequivalence and other testing, the
material will be used to produce both oral and topical drug product
presentations. Atossa clinical programs using its proprietary
Endoxifen include:
- Phase 2 study to determine if oral Endoxifen reduces tumor
activity in early stage breast cancer patients in the “window of
opportunity” between diagnosis of breast cancer and surgery (now
open for enrollment in Australia)
- Phase 2 study to determine if topical Endoxifen reduces
mammographic breast density (now open for enrollment in
Sweden)
- Phase 1 study of topical Endoxifen in men (enrollment and
dosing complete; results to be announced this quarter)
- Phase 2 study of topical Endoxifen to treat gynecomastia in men
being treated for prostate cancer (study targeted to open in Q4
2018)
- Phase 2 study of oral Endoxifen for patients who are
“refractory” to Tamoxifen (study targeted to open in 2H 2018)
“Our needs for the ongoing clinical supply of Endoxifen are
dramatically increasing as we advance our clinical studies,”
commented Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa.
“As a second Endoxifen manufacturer, Alchem will begin supplying
Endoxifen for one or more of our studies slated for later this
year. They will be an excellent partner, with their experience and
capabilities, to ensure we are poised to move our development
programs forward quickly, particularly in the U.S.,” added
Quay.
About Alchem Laboratories
Alchem is located in Gainesville, Florida. It has supplied APIs
for 16 active clinical studies, 13 of which were led by the
National Cancer Institute (NCI) and that Alchem has been supporting
through multiple R&D contracts for over fifteen years. In 2018,
Alchem added oral and injectable products to its topical product
manufacturing capabilities in its GMP clinical manufacturing
facility expansion.
Alchem provides qualified infrastructure and trained personnel
for all stages of drug development including design and synthesis
of novel compounds, synthesis of analogs of lead compounds, process
development and optimization, analytical method development and
validation, stability studies for drugs and intermediates, cGMP
manufacturing of APIs and products for clinical studies, and
documentation for all stages of drug development. Its partners and
collaborators include the NCI, part of the National Institutes of
Health (NIH), the National Institute of Standards and Technology
(NIST), the U.S. Army Medical Research Acquisition Activity
(USAMRAA), the U.S. Department of Agriculture (USDA), the Dr.
Margarete Fischer-Bosch-Institute of Clinical Pharmacology (ICP),
Gemphire Therapeutics, Inc., Cerenis Therapeutics Holding SA,
Brickell Biotech, Inc., FLUCEL LLC, Nanopharmaceutics, MRIGlobal,
Pace Analytical Labs, Southern Research, and the University of
Florida UF|INNOVATE - Sid Martin Biotech.
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
Source: Atossa Genetics Inc.
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