Atossa Genetics Provides Information on FDA Expanded Access Policy and Requests
July 17 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 that patients and their doctors
can now visit the company’s website to obtain information about
gaining access to the company’s proprietary Endoxifen pursuant to
the FDA’s “Expanded Access” guidelines. The company’s website
includes its Expanded Access policy as well as an automated
form that can be used by physicians to request that their patients
be considered for this program:
http://www.atossagenetics.com/clinical-trials/ - ea-form.
Sometimes called "compassionate use", Expanded Access is a
potential pathway for a physician to access an investigational
medical product (drug, biologic, or medical device) for treatment
outside of clinical trials when no comparable or satisfactory
alternative therapy options are available for their patient with a
serious disease or condition, or an immediately life-threatening
condition. For more information about this process, please see
the FDA website: FDA Expanded Use Website.
In December 2018, Atossa began providing its oral Endoxifen to a
pre-menopausal, estrogen-receptor positive (ER+), lacking CYP2D6
function, breast cancer patient under an FDA-approved
"Single-Patient Expanded Access" IND. The purpose of this
therapeutic approach was to reduce activity of the cancer cells
prior to surgery. The patient received daily doses of Atossa’s oral
Endoxifen for approximately three weeks prior to surgery. There
were no safety or tolerability issues and her surgery was
successfully completed. The cancer cell biological activity was
reduced, based on the estrogen receptor activity of the tumor cells
and a 50 percent reduction in Ki-67. The FDA subsequently approved
the use of Atossa’s oral Endoxifen for this patient following her
surgery under the same program.
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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