Atossa Genetics’ Preliminary Phase 2 Study Achieves Primary Endpoint: Topical Endoxifen Rapidly Reduces Breast Density
June 27 2019 - 8:00AM
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 a preliminary analysis from
its recently completed Phase 2 study of the company’s proprietary
20mg daily topical Z Endoxifen (“Endoxifen”) showed significant and
rapid reduction in mammographic breast density (MBD). Studies by
others using tamoxifen have demonstrated that density reduction
induced by tamoxifen is associated with a significant reduction in
breast cancer incidence.
A summary of preliminary results of the study follows:
- MBD was reduced by an average of 14.3 percent in the group
applying 20mg daily topical Endoxifen, which was statistically
significant (p = 0.02). In the lower dose group (10mg), MBD was
reduced by an average of 9.0 percent. These results are based on
MBD measurements at the time of enrollment in the study and again
at the time dosing ended, which was a mean of 55 and 88 days for
the 20mg and 10mg groups, respectively.
- Approximately 70 percent of participants receiving 20mg topical
Endoxifen experienced a reduction in MBD, and of those, the mean
reduction in MBD was 27 percent.
- There were no significant differences in systemic endocrine or
vascular side effects (for example, hot flashes) in the placebo
versus active groups. Systemic side effects were measured using a
modified validated symptom questionnaire. The most commonly
experienced side effect for both groups receiving active drug were
skin rashes and local irritation.
- The results indicate a study with approximately 50-100 subjects
per dosage group would be appropriate to demonstrate efficacy for
regulatory approval purposes.
Steven C. Quay, Ph.D., M.D., CEO and President of Atossa,
commented “We are thrilled that our proprietary topical Endoxifen
significantly reduced breast density. We believe that no other
drug, other than tamoxifen, has been clinically demonstrated to
significantly reduce breast density. We observed both a strong and
a rapid treatment effect, as demonstrated by our topical Endoxifen
producing treatment results in only 55 days of dosing for the 20mg
dose. This compares to the one year of dosing previously used in
oral tamoxifen studies. Our study also demonstrated that topical
Endoxifen did not produce the systemic endocrine and vascular side
effects that are often experienced with tamoxifen, such as hot
flashes. Because the 20mg dose produced a treatment effect in only
55 days and because daily dosing eventually produced skin rashes
and local irritation in most women, the topical form appears to be
particularly well-suited for short-term use – perhaps less than 60
days with dosing every-other day. These data will now inform our
decisions about dosing as well as development of our oral form of
Endoxifen. Our goal is to ultimately reduce the incidence of breast
cancer – by reducing MBD with our Endoxifen, which we believe can
reduce the number of women getting estrogen dependent (ER+) breast
cancer. This is analogous to statins rapidly reducing cholesterol
which has now been shown to reduce the risk of heart attack long
term.”
The Phase 2 MBD Study of Topical Endoxifen
Atossa’s Phase 2 study of topical Endoxifen was led by principal
investigator Dr. Per Hall, MD, Ph.D., Head of the Department of
Medical Epidemiology and Biostatistics at Karolinska Institutet,
Stockholm, Sweden. The double-blinded, placebo-controlled study
enrolled 90 participants who were randomized to one of three
different dose groups (30 per group): placebo; 10mg daily topical
Endoxifen; and 20mg daily topical Endoxifen. Participants applied
the topical product to the skin of each breast daily for up to six
months. The primary objective was to determine if there was a
change in breast density compared to placebo in order to permit
sample size calculations for statistical significance in a future
Phase 3 trial. The primary endpoint was individual reduction of MBD
as measured by mammography, and the secondary endpoints were to
assess and characterize safety and tolerability. Each participant
received a baseline (pre-treatment) mammogram with additional
mammograms taken at month 3 and 6, or at the time of study
exit.
Approximately 72 participants eventually developed skin rashes
and local irritation and did not complete a full six months of
dosing. However, the study yielded sufficient data to meet the
primary objective of determining sample size calculation for
subsequent studies. Based on the results achieved here, a
subsequent MBD study using topical Endoxifen would require
approximately 50 participants for the high dose formulation and
approximately 100 participants for the low dose group to achieve a
successful efficacy end point. Moreover, the study produced
valuable information about dosing duration and because there was a
treatment effect in only 55 days, the topical form of Endoxifen may
be particularly well suited for short-term use – for example fewer
than 60 days.
A study led by Sir Jack Cusick, director of the Wolfson
Institute of Preventive Medicine in London and head of the Centre
for Cancer Prevention, concluded that a 10 percent reduction in MBD
after one year of oral tamoxifen conferred at 63 percent reduction
in ER+ breast cancer (the most common form of breast cancer) after
five years (“Tamoxifen-Induced Reduction in Mammographic Density
and Breast Cancer Risk Reduction: A Nested Case–Control Study,”
Jack Cuzick, et. al. Journal of the National Cancer Institute, Vol
103, May 2011, pp. 744–752). Based on this and other work, the
company believes the positive results from this study are
clinically meaningful in the context of breast cancer risk
reduction.
Further Development of Atossa’s Endoxifen
Preliminary results of the study produced useful information
regarding dosing frequency and duration. A significant treatment
effect was achieved in only 55 days in the higher dose group.
Because daily dosing will eventually result in rashes and local
skin irritation in most patients, the company believes the topical
form of Endoxifen may be particularly well suited for short-term
use. Atossa will now be evaluating alternative dosing
regimens, such as every other day, as well as shorter overall
dosing such as fewer than 60 days.
Atossa is also preparing a Phase 2 study of its oral Endoxifen
to reduce MBD which we will begin as soon as possible.
About MBD
Legislation has been recently enacted in approximately 35 states
requiring that women be notified if they have MBD and those
notifications typically state that women with MBD have a higher
risk of developing breast cancer, and that mammography may not be
as effective in detecting breast cancer because the MBD can “mask”
the detection of cancers. In February 2019, Federal legislation was
enacted that requires that the FDA adopt rules requiring that
mammography reports include information about breast density and
inform women about their breast density. There is no FDA-approved
treatment to reduce MBD.
Atossa estimates that approximately ten million women in the
Unites States have MBD. Although oral tamoxifen is approved to
prevent breast cancer in “high-risk” women, it is used by less than
5 percent of women with an increased risk of developing breast
cancer because of the actual or perceived side effects and risks of
tamoxifen. The company believes its Endoxifen may provide an option
for women to proactively reduce the density of their breasts,
thereby reducing their risk of developing breast cancer. Moreover,
Atossa’s Endoxifen may improve mammography accuracy and patient
care by unmasking cancerous tumors that are otherwise obscured by
high breast density.
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
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Sep 2023 to Sep 2024