SEATTLE, WA, USA I June 26, 2017 I Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has received a positive interim safety assessment of the first cohort receiving proprietary oral Endoxifen in its Phase 1 dose escalation study. Endoxifen is an active metabolite of the FDA approved drug tamoxifen, which is indicated for breast cancer and breast cancer prevention in high-risk patients. The Independent Safety Committee reviewed the blinded data generated from the first cohort receiving the oral formulation (8 subjects) and concluded that the study may advance to the next oral dosing level.
The study includes two arms: one receiving a topical formulation of Endoxifen and another receiving an oral formulation, each with three cohorts. The topical arm has been fully enrolled and dosed and the first of the three oral cohorts has now been dosed.
“Our Phase 1 study of our proprietary Endoxifen is progressing quickly and as planned,” stated Dr. Steve Quay, CEO and President. “This interim safety determination allows us to proceed to the next dosing level and, based on the progress to date, we expect to complete enrollment in the next six weeks.”
The Phase 1 study is a double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects and its objectives are to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
About Atossa Genetics
Atossa Genetics Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
SOURCE: Atossa Genetics
Post Views: 31
SEATTLE, WA, USA I June 26, 2017 I Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has received a positive interim safety assessment of the first cohort receiving proprietary oral Endoxifen in its Phase 1 dose escalation study. Endoxifen is an active metabolite of the FDA approved drug tamoxifen, which is indicated for breast cancer and breast cancer prevention in high-risk patients. The Independent Safety Committee reviewed the blinded data generated from the first cohort receiving the oral formulation (8 subjects) and concluded that the study may advance to the next oral dosing level.
The study includes two arms: one receiving a topical formulation of Endoxifen and another receiving an oral formulation, each with three cohorts. The topical arm has been fully enrolled and dosed and the first of the three oral cohorts has now been dosed.
“Our Phase 1 study of our proprietary Endoxifen is progressing quickly and as planned,” stated Dr. Steve Quay, CEO and President. “This interim safety determination allows us to proceed to the next dosing level and, based on the progress to date, we expect to complete enrollment in the next six weeks.”
The Phase 1 study is a double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects and its objectives are to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
About Atossa Genetics
Atossa Genetics Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
SOURCE: Atossa Genetics
Post Views: 31
