On May 9, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported that the Institutional Review Board associated with Montefiore Medical Center (Biomedical Research Alliance of New York IRB) has approved the Fulvestrant Microcatheter Phase 2 study that was recently transferred to Montefiore (Press release, Atossa Genetics, MAY 9, 2017, View Source [SID1234518985]). Schedule your 30 min Free 1stOncology Demo! The Fulvestrant Microcatheter Phase 2 study includes women with ductal carcinoma in-situ (DCIS) or invasive breast cancer slated for mastectomy or lumpectomy. This study will assess the safety, tolerability and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same product intramuscularly. The secondary objective 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 specimen. 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. Six study participants will receive the standard intramuscular fulvestrant dose of 500 mg to establish the reference drug distribution, and 24 participants will receive fulvestrant by intraductal instillation utilizing Atossa’s microcatheter device.
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"This study was initiated at The Columbia University Medical Center Breast Cancer Program and then transferred to Montefiore Medical Center at the beginning of 2017 when the principal investigator moved his practice to Montefiore," commented Steven Quay, CEO and President. "We are pleased that the study continues to move forward at Montefiore, which is a leading center for breast cancer treatment."