Atossa Genetics Completes Enrollment in Phase 2 Study of Topical Endoxifen in Women with Mammographic Breast Density
11 October 2018 - 11:00PM
Atossa Genetics Inc. (NASDAQ:
ATOS), a
clinical-stage biopharmaceutical company developing novel
therapeutics and delivery methods for breast cancer and other
breast conditions, has completed enrollment in its Phase 2 study of
Atossa’s proprietary Topical Endoxifen in women with mammographic
breast density, or MBD.
This double-blinded, placebo-controlled Phase 2 study is being
conducted at Stockholm South General Hospital in Sweden. The study
is being led by principal investigator Dr. Per Hall, MD, Ph.D.,
Head of the Department of Medical Epidemiology and Biostatistics at
Karolinska Institutet. “We are very pleased with the speed at
which the study has fully enrolled 90 participants in under 6
weeks,” commented Dr. Hall. “This fast enrollment is a testament to
the hard work and superlative service of my dedicated staff and the
positive experience patients have had with this novel topical
drug,” continued Dr. Hall.
Steve Quay, MD, Ph.D., CEO and President of Atossa, commented,
“We are thrilled with Dr. Hall’s and his team’s work on our lead
Endoxifen program and the rapid progress at his clinic. Quick
enrollment in clinical trials can be a good indicator that there is
strong demand for a therapy in an underserved market.”
The primary endpoint of the study is to determine if daily
Topical Endoxifen administration results in an individual change in
MBD, which will be measured after three and six months of entering
the study. The secondary endpoints are safety and tolerability.
Ninety participants were randomized to one of three groups (one
placebo group and two groups of different strengths of Topical
Endoxifen) with 30 participants per group. The objective of the
study is to determine if MBD is reduced, and if so, the results
will drive sample size calculations for a future a Phase 3
study.
Summary of Atossa’s Clinical Pipeline
Atossa has two development programs: Endoxifen (topical and oral
forms) and a program for the targeted delivery of drugs and
immunotherapies via its proprietary intra ductal microcatheters to
treat early breast cancer.
Atossa’s Endoxifen program consists of clinical studies to
address the three segments of the Breast Cancer Continuum as well
as gynecomastia, and include:
- Phase 2 study to determine if Oral Endoxifen reduces tumor
activity in early stage breast cancer patients in the “window of
opportunity” between diagnosis of breast cancer and surgery (now
open for enrollment in Australia)
- Phase 2 study to determine if Topical Endoxifen reduces MBD
(enrollment completed in Sweden)
- A completed Phase 1 study of Topical Endoxifen in men that
supports further development in men with gynecomastia induced by
androgen deprivation therapy
- Phase 2 study of Topical Endoxifen to treat gynecomastia in men
being treated with androgen deprivation therapy for prostate cancer
(retaining CRO in Q4 2018)
- Phase 2 study of Oral Endoxifen for patients who are not
benefiting from (meaning they are “refractory”) Tamoxifen
(retaining CRO in Q4 2018)
Atossa’s Proprietary Topical Endoxifen
Atossa is developing its proprietary Topical Endoxifen to treat
or prevent breast health conditions in both men and women. For
women, the proprietary Topical Endoxifen is being developed to
treat MBD. Legislation that has been recently enacted in over 30
states requires 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.
As many as approximately 10 million women in the United States
have high MBD, for which there is no FDA-approved treatment. MBD
increases the risk of developing breast cancer. Although oral
tamoxifen is approved to prevent new or recurrent estrogen-receptor
positive early stage breast cancer and to treat metastatic breast
cancer patients, it is rarely used in women who have not developed
breast cancer who have an increased risk of developing breast
cancer. Tamoxifen can have side effects that are difficult to
tolerate and it has the risk of more serious side effects such as
blood clots and strokes.
For men, Atossa is developing Topical Endoxifen to prevent a
condition called gynecomastia, for which there is no FDA-approved
pharmaceutical. Gynecomastia is male breast enlargement and
accompanying pain, which according to the Mayo Clinic affects 25%
of men in the U.S. between the ages of 50-69, or approximately 10
million men. It is the most common male breast disorder and is
caused by a hormone imbalance where testosterone is low compared to
estrogen. Gynecomastia is caused by, among other things, any number
of commonly prescribed medications, such as androgen deprivation
therapy to treat prostate enlargement and prostate cancer,
anti-anxiety medications, cancer treatments (chemotherapy), and
some heart medications. Subject to further clinical studies and
regulatory approval, Topical Endoxifen could fill a significant
unmet medical need in reducing gynecomastia in men taking androgen
deprivation therapy to treat prostate cancer.
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 Guse CFO and General Counsel Office:
866 893-4927 kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott Gordon CoreIR 377 Oak Street Concourse 2 Garden City, NY
11530 Office: 516 222-2560 scottg@CoreIR.com
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