Atossa Genetics provides information on FDA Expanded Acess policy
Atossa Genetics 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. In December 2018, Atossa began providing its oral Endoxifen to a pre-menopausal, estrogen-receptor positive 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.