Atossa Genetics Inc. (NASDAQ:
ATOS), a
clinical-stage biopharmaceutical company developing novel
therapeutics and delivery methods for breast cancer and other
breast conditions, and The Dr. Susan Love Research Foundation,
announced today that the Institutional Review Board (IRB) has
approved a Phase 2 clinical study of Atossa’s intraductal
microcatheter technology for the administration of fulvestrant in
patients with early-stage breast cancer or ductal carcinoma in situ
(DCIS). Susan Love, M.D., inventor of the technology, will advise
Atossa as it conducts the trial.
“We have contracted with a world-class teaching, research and
healthcare organization based in the United States to conduct this
study,” commented Steven C. Quay, Ph.D., M.D., CEO and President of
Atossa. “Atossa’s intraductal technology was invented by Dr. Love
and subsequently acquired by Atossa. We are honored that Dr. Love
has agreed to work with us on this important new study. This work
begins as Atossa increases its corporate focus on its proprietary
Endoxifen for the reduction of mammographic breast density.”
For the past 20 years, Dr. Love has dedicated her career to the
eradication of breast cancer and pioneered some of the world’s more
innovative research. From spearheading a partnership with NASA’s
Jet Propulsion Laboratory to mapping the breast ductal system, to
harnessing the power of artificial intelligence to develop a
handheld, self-reading ultrasound for breast cancer screening in
underserved populations, Dr. Love’s goal is to end breast
cancer.
“While the origin of breast cancer is still not well understood,
we do know a few things,” stated Dr. Love. “Each breast is
comprised of six to 12 duct-lobule units that develop from one or a
few stem cells at the time of puberty. In the vast majority of
cases, when a woman gets breast cancer it is one and only one of
those units; the rest of the breast is without disease. It was on
the basis of this understanding that, years ago, I began to
envision treatments that focused on the ‘sick duct’ only. Over the
years a number of clinical trials have been conducted that
demonstrate this approach leads to strong tumor treatment effects,
because of the local delivery, and reduced systemic exposure, which
hopefully produces fewer side effects. I am pleased that Atossa
Genetics and a leading institution are carrying on the research I
began and I look forward to advising on this important clinical
trial.”
Intraductal Breast Cancer Treatment: The Phase 2
Study
Fulvestrant is FDA-approved for metastatic breast cancer. It is
administered as a monthly intramuscular injection of two
injections, typically into the buttocks. The AstraZenica branded
drug, Faslodex, had worldwide sales of over $1 billion US in
2018.
This trial is a Phase 2 study in women with Stage 1 or 2 breast
cancer (invasive ductal carcinoma) or DCIS scheduled for mastectomy
or lumpectomy within 14 to 45 days. This study will assess the
safety, tolerability, cellular activity and distribution of
fulvestrant when delivered directly into breast milk ducts via
Atossa’s intraductal technology, compared to those who receive the
same drug by injection. Of the 30 patients required for full
enrollment, six will receive the standard intramuscular injection
of fulvestrant and 24 will receive fulvestrant with Atossa’s
intraductal technology.
The primary endpoint of the clinical trial is to compare the
safety, tolerability and distribution of fulvestrant between the
two routes of administration (intramuscular injection or through
Atossa’s intraductal technology). The secondary endpoint of the
study is to determine if there are changes in the expression of
Ki67 as well as estrogen and progesterone receptors between a
pre-fulvestrant biopsy and post-fulvestrant surgical specimens.
Digital breast imaging before and after drug administration in both
groups will also be performed to determine the effect of
fulvestrant on any lesions as well as breast density of the
participant. This Phase 2 study is currently underway at Montefiore
Medical Center, which will transition all future work to the new
study site.
Additional information can be found in our SEC filings at:
https://www.sec.gov/Archives/edgar/data/1488039/000143774919020029/atos20191011_8k.htm
and in the NIH website at:
https://www.clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2#contacts
Atossa Genetics is the owner of issued patents, pending patent
applications, and medical device FDA 510(k) premarket notifications
related to the treatment of breast conditions, including breast
cancer and DCIS.
About Dr. Susan Love Breast Foundation for
Research
The Dr. Susan Love Foundation for Breast Cancer Research’s
mission is to end breast cancer. It challenges the status quo to
end breast cancer and improve the lives of people impacted by it
now through education and advocacy. The Foundation drives
collaborative, cutting-edge research with nontraditional partners,
brings to light the collateral damage of treatment and seeks ways
to diminish it, and interprets science to empower patients. Fast,
flexible, and project-based, the Foundation actively engages the
public in scientific research to ensure that it produces accurate
and meaningful results.
For more information please visit
https://drsusanloveresearch.org/.
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
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