Atossa Genetics Inc. (NASDAQ:ATOS) Files An 8-K Other Events
Item 8.01
On October 14, 2019, Atossa Genetics Inc. (“Atossa”) entered into a clinical trial agreement with The Johns Hopkins University to conduct a Phase 2 clinical study of Atossa’s intraductal microcatheter technology for the administration of fulvestrant in patients with early-stage breast cancer or ductal carcinoma in situ (DCIS). The Institutional Review Board (IRB) has approved the study. Susan Love, M.D., inventor of the technology, which was subsequently acquired by Atossa, will advise Atossa on the study.
This trial is a Phase 2 study in women with Stage 1 or 2 breast cancer (invasive ductal carcinoma) or DCIS scheduled for mastectomy or lumpectomy within 14 to 45 days. This study will assess the safety, tolerability, cellular activity and distribution of fulvestrant when delivered directly into breast milk ducts via Atossa’s intraductal technology, compared to those who receive the same drug by injection. Of the 30 patients required for full enrollment, six will receive the standard intramuscular injection of fulvestrant and 24 will receive fulvestrant with Atossa’s intraductal technology. Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two injections, typically into the buttocks.
The primary endpoint of the clinical trial is to compare the safety, tolerability and distribution of fulvestrant between the two routes of administration (intramuscular injection or through Atossa’s intraductal technology). The secondary endpoint 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 specimens. 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. This Phase 2 study is currently underway at Montefiore Medical Center, which will transition all future work to Johns Hopkins.
Atossa Genetics is the owner of issued patents, pending patent applications, and medical device FDA 510(k) premarket notifications related to the treatment of breast conditions, including breast cancer and DCIS.
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About Atossa Genetics Inc. (NASDAQ:ATOS)
Atossa Genetics Inc. is a clinical-stage pharmaceutical company focused on the development of therapeutics and delivery methods for the treatment of breast cancer and other breast conditions. The Company’s leading program uses its intraductal microcatheters, which deliver pharmaceuticals through the breast ducts. It has initiated a Phase II clinical study using its microcatheters to deliver fulvestrant as a treatment of ductal carcinoma in-situ (DCIS) and breast cancer. Its second pharmaceutical program under development is Afimoxifene Topical Gel (AfTG) for the treatment and prevention of hyperplasia of the breast. It is also engaged in the process of evaluating other therapeutic candidates to treat other breast conditions, including breast cancer. Its medical devices include the ForeCYTE Breast Aspirator and the FullCYTE Breast Aspirator. These devices are intended for the collection of nipple aspirate fluid (NAF) for cytological testing at a laboratory.