Atossa Therapeutics Inc (ATOS)

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Atossa Therapeutics Announces Receipt of FDA Safe to Proceed Letter for Treatment of an Ovarian Cancer Patient with Oral Endoxifen Under Expanded Access Pathway
March 11, 2021 09:30 ET | Source: Atossa Therapeutics, Inc.




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SEATTLE, March 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases today announced the FDA has issued a “Safe to Proceed” letter under their Expanded Access Pathway, permitting the use of Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief.

“Dr. Goff recently contacted Atossa with an interest in gaining access to our Endoxifen under the FDA’s expanded access, or compassionate use, program for one of her patients,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient has recurrent ovarian cancer and recently underwent functional molecular genomic testing, using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor. The organoid testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We are gratified to be able to help this patient and are anxious to follow her response to this drug combination. If the drug combination shows promise in this patient, Atossa will consider doing additional clinical studies in patients with ovarian cancer.”

Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient. Approval from the Institutional Review Board (IRB) must be obtained prior to providing oral Endoxifen to this patient.

About FDA Expanded Access

Sometimes called "compassionate use," expanded access is a potential pathway for a patient with serious disease or condition, or an immediately life-threatening condition, to gain access to 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 more information about this process, please see the FDA website: FDA Expanded Use Website

https://www.globenewswire.com/news-release/2021/03/11/2191501/0/en/Atossa-Therapeutics-Announces-Receipt-of-FDA-Safe-to-Proceed-Letter-for-Treatment-of-an-Ovarian-Cancer-Patient-with-Oral-Endoxifen-Under-Expanded-Access-Pathway.html