Atossa Genetics President and CEO Dr. Steven C. Quay Issues Annual Letter to Shareholders Highlighting Key Accomplishments a...
January 28 2019 - 8:00AM
Atossa Genetics Inc. (Nasdaq:ATOS) today issued the following
letter from Dr. Steven C. Quay, President and CEO, to Atossa
shareholders:
To Our Valued Shareholders:
I begin this letter with a sense of great pride about our
accomplishments at Atossa. In 2018, we completed our transformation
into a Phase 2 clinical-stage pharmaceutical company. Building on
that momentum, our 2019 goals are a three-fold, laser-focused
clinical program to continue the development of novel therapeutics
and delivery methods to: 1) treat breast cancer, 2) reduce the risk
of breast cancer, and 3) prevent/reduce gynecomastia.
Throughout 2018, we advanced our Endoxifen programs into Phase 2
clinical studies for estrogen receptor positive (ER+) breast cancer
and executed a research and development program of immunotherapies
(such as Chimeric Antigen Receptor Therapy, or CAR-T) intended for
targeted delivery via our proprietary microcatheters for the
potential treatment of “triple negative” breast cancer (TNBC) and
BRCA+ breast cancer. Our key achievements in 2018 include:
- Expanded Access Oral Endoxifen U.S. Clinical Study:
Window of Opportunity. The FDA approved the use of our
oral Endoxifen (4 mg per day) for a pre-menopausal, ER+ breast
cancer patient awaiting surgery. Endoxifen has been reported in the
literature to play an important role in reducing breast cancer cell
activity. Additionally, higher endoxifen levels correlate to lower
recurrence/new tumors in ER+ breast cancer patients after
surgery. We have previously reported that during our prior
Phase I study of oral Endoxifen, a 4 mg daily dose reached
steady-state, therapeutic blood levels within one week, which were
over 200 percent higher than the endoxifen blood levels achieved
with the current standard of care, 20 mg daily tamoxifen (as
reported in the literature), in patients who metabolize tamoxifen
effectively and over 900 percent higher in those who do not. We
look forward to reporting on progress.
- Phase 2 Oral Endoxifen Study: Window of
Opportunity. We commenced our Phase 2 clinical study in
Australia using our proprietary oral Endoxifen in the “window of
opportunity” between diagnosis of ER+ breast cancer and surgery, to
determine if pre-surgical dosing actually reduces the biological
activity of the tumor, as measured by the tissue biomarker, Ki-67,
and other parameters.We previously reported that oral Endoxifen
administered in our Phase 1 study was not associated with a
significant change in vasomotor symptoms, i.e., hot flashes and
night sweats, and in fact had a level of endocrine symptoms that
was not different from placebo. Current conventional hormone
therapy (tamoxifen or aromatase inhibitors) are associated with a
significant and substantial change in endocrine symptoms. If our
oral Endoxifen continues to maintain this tolerance profile, it
could provide a “gentler” approach to breast cancer therapy. This
study is open for enrollment.
- Phase 2 Topical Endoxifen Study: Mammographic Breast
Density. We have advanced our Phase 2 clinical study in
Sweden using our proprietary topical Endoxifen in women with high
mammographic breast density, or MBD. The study was fully enrolled
in October 2018 and we expect to finish dosing by the end of the
second quarter of 2019, and to report initial results thereafter.In
a study of woman taking oral tamoxifen, a 10 percent reduction of
MBD at one year conferred a 63 percent reduction in breast cancer
at five years.1
- Phase 1 Study: Topical Endoxifen in Men. We
completed a Phase 1 clinical study in male subjects with all safety
and tolerance objectives achieved.
- Intraductal Immunotherapy R&D. We launched
our intraductal microcatheter immunotherapy R&D program. This
is a novel approach using our proprietary intraductal microcatheter
technology for the potential of TRAnsPapillary, or “TRAP,” delivery
of genetically modified cells or immunomodulatory cytokines to
attack breast cancer cells. This method has several potential
advantages, such as: reducing potential toxicity by delivering the
immunotherapy directly to the breast milk ducts, thus limiting
systemic exposure; improving efficacy by placing the modified cells
in direct contact with the target the malignant ductal epithelial
cells; and, the potential for the modified cells to migrate through
the regional lymphatic system and extending their cytotoxic
actions, which could limit tumor cell dissemination.During 2018, we
received an opinion from the World Intellectual Property
Organization that certain claims in our patent application for TRAP
therapy were “novel.” The invention is related to: “A
transpapillary method of adoptive cell therapy for treatment of a
subject having or at risk of having a breast disorder comprising
administering cells into a breast duct of the subject, wherein the
cells comprise modified ceils expressing one or more recombinant
receptors that bind a target antigen on a breast cell, wherein the
one or more recombinant receptors comprises a chimeric antigen
receptor (CAR).” While there can be no assurance this opinion will
be upheld or that a patent will issue with this claim, it is
gratifying that our ground-breaking science is being
recognized.
- Additional U.S. Manufacturing. We have
contracted with an additional manufacturer in the United States for
the production of Endoxifen.
- Capital Raising. In May, we completed a rights
offering that resulted in approximately $13.4 million in gross
proceeds for our company. This financing significantly added to our
capital resources, allowing us to execute on our ongoing clinical
trials and other related activities.
- Strategic Board. We formed a strategic
advisory board comprised of prominent executives from the
pharmaceutical industry and academia to play a key role in a number
of important initiatives, including seeking key industry partners
to accelerate the clinical development of our Endoxifen
programs.
In 2019, we will continue to focus on advancing the clinical
development of our proprietary Endoxifen and our intraductal
microcatheter programs:
- Oral Endoxifen. The 2019 goal for our oral
Endoxifen program is to continue clinical studies to help us
understand the full “metes and bounds” of the clinical potential of
this therapeutic. Specifically, we plan to determine if Endoxifen
has an improved safety and tolerability profile compared to other
hormone treatments. If so, we will determine whether Endoxifen,
because of clinical data suggesting superiority to other hormone
therapies, might augment or even replace other hormone therapies in
important, clinical settings. We hope to end the year with a
pharmacological profile for oral Endoxifen that can inform both
further clinical trials as well as partnering
discussions.
- Topical Endoxifen. The 2019 goal for our
topical Endoxifen program is to determine whether an important,
clinically-validated imaging biomarker -- mammographic breast
density -- can be reduced by Endoxifen formulated for transdermal
(through the skin) administration. We anticipate that dosing in the
Phase 2 MBD study will conclude in the second quarter 2019 with
initial results to follow. The results of this study will drive the
further development of our proprietary topical Endoxifen, not only
for MBD but also for preventing and/or reducing gynecomastia in men
being treated for prostate cancer.
- Intraductal Microcatheter Technology. We will
continue to advance our intraductal microcatheter technology
program: continuing the Phase 2 clinical study using our
proprietary intraductal microcatheter technology to administer
fulvestrant in the Window of Opportunity for women with ER+ breast
cancer, and continuing our R&D program to develop TRAP to
administer immunotherapies for women with triple negative breast
cancer and/or BRCA+ breast cancer. We developed and validated
preclinical methods to administer immunotherapy to the site of
tumor initiation.These studies are the first of several steps to
develop our intraductal microcatheter technology to treat breast
cancer with cell-based immunotherapy, and will form the basis for
supporting human studies, with the ultimate goal of treating breast
cancer by administering an immunotherapy with our proprietary
microcatheter technology.
Atossa is an exceptional company focused on novel therapeutics
and delivery methods for breast diseases for which additional or
new treatments are needed. We look forward to reporting our
progress on our priorities throughout the year and we thank you for
your continued support of Atossa.
Sincerely,
Dr. Steven C. Quay, MD, Ph.D.President and Chief Executive
Officer
About Atossa Genetics
Atossa Genetics Inc. (NASDAQ:ATOS) is a clinical-stage
pharmaceutical 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 actions and inactions by
the FDA, the outcome or timing of regulatory approvals needed by
Atossa, lower than anticipated rate of patient enrollment, higher
than anticipated drop-outs by study participants including because
of skin irritations in our Phase 2 MBD study, results of clinical
studies, 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, such as
patent rights, 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:
Kyle Guse CFO and General Counsel (O) 866 893-4927
kyle.guse@atossagenetics.com
Investor Relations ContactScott Gordon CorProminence LLC 377 Oak
Street Concourse 2 Garden City, NY 11530 Office: 516.222.2560
scottg@coreir.com
Source: Atossa Genetics Inc
1 https://academic.oup.com/jnci/article/103/9/744/918777
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