Atossa Genetics Provides Information on FDA Expanded Access Policy and Requests

Date : 07/17/2019 @ 1:30PM
Source : GlobeNewswire Inc.
Stock : Atossa Genetics Inc (ATOS)
Quote : 2.02  0.01 (0.50%) @ 1:00AM

Atossa Genetics Provides Information on FDA Expanded Access Policy and Requests

Atossa Genetics (NASDAQ:ATOS)
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Atossa Genetics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today reported that patients and their doctors can now visit the company’s website to obtain information about gaining access to the company’s proprietary Endoxifen pursuant to the FDA’s “Expanded Access” guidelines. The company’s website includes its  Expanded Access policy as well as an automated form that can be used by physicians to request that their patients be considered for this program: http://www.atossagenetics.com/clinical-trials/ - ea-form.

Sometimes called "compassionate use", Expanded Access is a potential pathway for a physician to access an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available for their patient with a serious disease or condition, or an immediately life-threatening condition. For more information about this process, please see the FDA website: FDA Expanded Use Website.

In December 2018, Atossa began providing its oral Endoxifen to a pre-menopausal, estrogen-receptor positive (ER+), lacking CYP2D6 function, breast cancer patient under an FDA-approved "Single-Patient Expanded Access" IND. The purpose of this therapeutic approach was to reduce activity of the cancer cells prior to surgery. The patient received daily doses of Atossa’s oral Endoxifen for approximately three weeks prior to surgery. There were no safety or tolerability issues and her surgery was successfully completed. The cancer cell biological activity was reduced, based on the estrogen receptor activity of the tumor cells and a 50 percent reduction in Ki-67. The FDA subsequently approved the use of Atossa’s oral Endoxifen for this patient following her surgery under the same program.

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

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