Atossa Genetics Announces Institutional Review Board Approval of Oral Endoxifen as Post-Mastectomy Treatment for a U.S. Breast Cancer Patient
SEATTLE, March 26, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that the Institutional Review Board (IRB) has approved the use of Atossa's oral Endoxifen as a post-mastectomy treatment in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient. This IRB approval follows the FDA's recent "safe to proceed" letter and permits Atossa's oral Endoxifen to be provided to the patient.
"IRB approval was the final step in making our oral Endoxifen available to this patient," commented Dr. Steven C. Quay, President and CEO of Atossa. "We are encouraged that the regulatory authorities recognize the potential for additional treatment options for pre-menopausal breast cancer patients. The impact of our proprietary oral Endoxifen on this patient's tumor during the pre-surgical treatment window is consistent with research by others, and strongly supports the continued development of our proprietary oral Endoxifen."
Under the FDA expanded access IND program, the use of Atossa's proprietary oral Endoxifen is restricted solely 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
About Atossa's Proprietary Endoxifen in Breast Cancer
Endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to prevent new as well as recurrent disease in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Studies by others have shown that breast cancer patients with endoxifen levels of 30 nM and above have a lower risk for developing future breast cancer. Up to half of the patients taking tamoxifen do not produce therapeutic levels of endoxifen, frequently because of limited liver metabolism capability.
Studies by others indicate that endoxifen's molecular mechanisms of action are concentration dependent and different than that of other anti-estrogens, including fulvestrant. Pathway analysis of differentially regulated genes revealed substantial differences related to endoxifen concentrations including significant induction of cell cycle arrest and markers of apoptosis following treatment with high, but not low, concentrations of endoxifen.
Many patients taking tamoxifen eventually stop responding, becoming tamoxifen refractory. In a small study by others of oral endoxifen use by tamoxifen refractory patients, endoxifen provided an acceptable safety profile and promising antitumor activity. Another class of drugs called aromatase inhibitors are also frequently used to treat breast cancer. However, they are not FDA-approved for use in pre-menopausal women and can only be given to pre-menopausal women in conjunction with drugs for ovarian suppression/oblation, which can cause cardiovascular and other toxicities. Additionally, 20-30 percent of those taking aromatase inhibitors may experience factures, bone pain or osteoporosis. Because of these potential advantages, Atossa is developing oral and topical forms of Endoxifen.
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 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, higher than anticipated drop-outs by study participants including because of skin irritations in our Phase 2 breast density study, 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, 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.
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