Atossa Genetics Completes Enrollment in Endoxifen Phase 1 Study and Provides Update on Fulvestrant Microcatheter Phase 2 Stud...
July 25 2017 - 9:16AM
Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical
company developing novel therapeutics and delivery methods for
breast cancer and other breast conditions, has now completed
enrollment in its Phase 1 dose escalation study of Atossa's
proprietary Endoxifen. Endoxifen is an active metabolite of the
FDA-approved drug tamoxifen, which is currently used to treat
breast cancer and for breast cancer prevention in high risk
patients.
“We have now completed enrollment in both the oral and topical
arms of our proprietary Endoxifen Phase 1 dose escalation study,”
commented Dr. Steven Quay, CEO and President of Atossa. “The speed
at which this study fully-enrolled is a testament to the enthusiasm
for potential new therapies in the breast cancer field, as well as
the hard work and dedication of our CRO, CPR Pharma, and the
personnel at Atossa. We hope to report initial top-line data
before the end of the quarter and then, subject to favorable Phase
1 results and other regulatory requirements, proceed to one or more
Phase 2 studies using both our oral and topical formulations,”
added Dr. Quay.
The objectives of this double-blinded, placebo-controlled,
repeat dose study of 48 healthy female subjects is to assess the
pharmacokinetics of proprietary formulations of both oral and
topical Endoxifen dosage forms over 28 days, as well as to assess
safety and tolerability. The study is being conducted in two parts
based on route of administration.
Atossa has also now completed the transfer of its Fulvestrant
Microcatheter Phase 2 study from Columbia University Medical Center
Breast Cancer Programs, where the study was initiated, to
Montefiore Medical Center, New York, NY.
“We are pleased to report that the study has been transferred to
Montefiore, which is a nationally-ranked hospital,” commented Dr.
Quay. “While we cannot project the timing of completing enrollment
in the study at this time, we look forward to providing updates as
this clinical trial continues to advance,” stated Dr. Quay.
The Fulvestrant Microcatheter Phase 2 study includes 30 women
with ductal carcinoma in-situ (DCIS) or invasive breast cancer
slated for mastectomy or lumpectomy. This study will assess the
safety, tolerability and distribution of fulvestrant when delivered
directly into breast milk ducts of these patients via
microcatheters compared to those who receive the same product
intramuscularly. The secondary objective 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 specimen. 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. Six study
participants will receive the standard intramuscular fulvestrant
dose of 500 mg to establish the reference drug distribution, and 24
participants will receive fulvestrant by intraductal instillation
utilizing Atossa’s proprietary microcatheter technology.
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 actions and inactions by
the FDA, the outcome or timing of regulatory approvals needed by
Atossa, lower than anticipated rate of patient enrollment, 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 with respect to fulvestrant, 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:
Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
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
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