Atossa Genetics Announces Preliminary Results from Phase 1 Study of Topical Endoxifen
September 14 2017 - 1:00PM
***All Objectives Successfully
Met***
Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical
company developing novel therapeutics and delivery methods for
breast cancer and other breast conditions, reported preliminary
results from its Phase 1 dose escalation study of its proprietary
topical Endoxifen. All objectives were successfully met:
- Safety: There were no clinically significant
safety signals and no clinically significant adverse events in
participants receiving topical Endoxifen.
- Tolerability: Topical Endoxifen was well
tolerated at each dose level and for the dosing duration utilized
in the study.
- Pharmacokinetics: Topical Endoxifen crossed
the skin barrier when applied daily to the breast, as demonstrated
by low but measurable Endoxifen blood levels detected in a
dose-dependent fashion.
These data demonstrate the suitability of topical endoxifen for
further clinical development.
Atossa expects to announce results from the oral arm of the
Phase 1 study in the next 30-60 days.
The Phase 1 Study
The Phase 1 study was a double-blind, placebo-controlled, repeat
dose study of 48 healthy female subjects. Atossa assessed
safety, tolerability and the pharmacokinetics of proprietary
formulations of both topical and oral Endoxifen dosage forms in
varying dose levels over 28 days. The study was conducted in two
parts based on route of administration. Results from the oral
arm of the study are expected in the next 30 to 60 days.
Atossa’s Proprietary Endoxifen
Endoxifen is an active metabolite of tamoxifen. Tamoxifen
is an FDA-approved drug to prevent new breast cancer as well as
recurrent breast cancer in breast cancer patients. Tamoxifen
itself must be broken down by the liver into active compounds
(metabolites), of which Endoxifen is the most active.
Topical Endoxifen. A condition called breast
density (or, MBD), typically diagnosed by a mammogram, has been
shown to be an independent breast cancer risk factor. To
date, 30 states require that findings of MBD be directly
communicated to the patient. We believe a topical form of
Endoxifen could potentially reduce MBD. Although oral
tamoxifen has been shown to reduce MBD, the benefit-cost ratio is
not acceptable to most physicians and their patients. For example,
it is estimated that only ~ 2% of women at high-risk of developing
breast cancer including those with MBD take oral tamoxifen to
prevent breast cancer because of the risk of, or actual
side-effects of, oral tamoxifen. Therefore we expect our next study
to focus on the potential for Atossa’s topical Endoxifen to reduce
MBD.
Oral Endoxifen. Although approximately one
million breast cancer survivors take tamoxifen annually, up to half
of them do not benefit from tamoxifen, meaning they are
“refractory,” for a number of reasons including that they do not
properly metabolize tamoxifen. Low endoxifen levels in breast
cancer patients taking oral tamoxifen are associated with an
increased risk of recurrence or the development of new breast
tumors. Thus providing oral Endoxifen directly to the patient
without having to be metabolized may help to address this
problem.
Based on the number of women at high-risk of developing breast
cancer and the number of patients who have survived breast cancer
but are not benefiting from tamoxifen, Atossa estimates that the
potential markets for its proprietary oral and topical formulations
of Endoxifen could each potentially exceed $1 billion in annual
sales.
Next Steps
“Based on these positive preliminary results, we are advancing
our topical Endoxifen into Phase 2 studies,” commented Dr. Steven
C. Quay, CEO and President. “We look forward to announcing
the results from the oral arm of our Phase 1 study in the coming 30
to 60 days,” continued Dr. Quay.
Breast Cancer Statistics
The American Cancer Society (ACS) estimates that approximately
250,000 women will be diagnosed with breast cancer in the United
States this year and that approximately 40,000 will die from the
disease. It is the second leading cause of cancer death in
American women. Although about 100 times less common than women,
breast cancer also affects men. The ACS estimates that the
lifetime risk of men getting breast cancer is about 1 in 1,000;
2,470 new cases of invasive breast cancer will be diagnosed; and
460 men will die from breast cancer in 2017.
Conference Call
Atossa Genetics will host a conference call to discuss
preliminary results today at 2pm eastern time.
To listen to the call by phone, interested parties within the
U.S. should call 1-844-824-3830 and International callers should
call 1-412-317-5140. All callers should ask for the Atossa Genetics
conference call. The conference call will also be available through
a live webcast at www.atossagenetics.com. Details for the webcast
may be found on the Company’s IR events page at
http://ir.atossagenetics.com/ir-calendar.
A replay of the call will be available approximately one hour
after the end of the call through October 14, 2017. The replay can
be accessed via Atossa's website or by dialing 877-344-7529
(domestic) or 412-317-0088 (international) or Canada Toll Free at
855-669-9658. The replay conference ID number is 10112105.
About Atossa Genetics
Atossa Genetics Inc., 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 any variation between
preliminary and final clinical results, actions and inactions by
the FDA, the outcome or timing of regulatory approvals needed by
Atossa, 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 Mar 2024 to Apr 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
From Apr 2023 to Apr 2024